Summary: Drugs which have received FDA approval for human testing but have yet to be approved for commercial marketing. This includes drugs used for treatment while they still are undergoing clinical trials (Treatment IND). The main heading includes drugs under investigation in foreign countries.
Publications263 found, 100 shown here
- Can single-patient investigational new drug studies hurry slow trains to the fast track?Dale Chenoweth
Drug Discov Today 11:185-6. 2006..Tips from an Irish playwright and a Finnish oncologist could help the United States' National Cancer Institute reach its 2015 goal...
- Trends in risks associated with new drug development: success rates for investigational drugsJ A DiMasi
Tufts Center for the Study of Drug Development, Tufts University, Boston, Massachusetts, USA
Clin Pharmacol Ther 87:272-7. 2010..The estimated transition probabilities were also higher for all clinical phases with respect to large molecules...
- Preclinical evaluation of long-acting muscarinic antagonists: comparison of tiotropium and investigational drugsPaola Casarosa
Department of Pulmonary Diseases Research, BI Pharma, Birkendorferstrasse 65, Biberach an der Riss, Germany
J Pharmacol Exp Ther 330:660-8. 2009....
- Comparison of maximum drug concentration and area under the time-concentration curve between humans and animals for oral and intravenous investigational drugsTomoe Fujita
Clinical Investigation Center, Kitasato East Hospital, Asamizodai 2 1 1, Sagamihara, Kanagawa 228 8520, Japan
J Clin Pharmacol 46:674-92. 2006..and developed relationships for C(max) and AUC between humans and animals for 75 oral and 10 intravenous investigational drugs. For the oral drugs, animal-human ratios of C(max) were different among animals in both normalizations...
- Current investigational drugs for major depressionShrinivas K Kulkarni
University Institute of Pharmaceutical Sciences, Pharmacology Division, Panjab University, Chandigarh, India
Expert Opin Investig Drugs 18:767-88. 2009..The World Health Organization (WHO) report has predicted that major depression will become a key cause of illness-induced disability by the year 2020, second only to ischemic heart diseases...
- Drug development for neglected diseases: a deficient market and a public-health policy failurePatrice Trouiller
Centre Hospitalier Universitaire, BP 217, 38043 Grenoble Cedex 9, France
Lancet 359:2188-94. 2002..Private-sector research obligations should be explored, and a public-sector not-for-profit research and development capacity promoted...
- "Promiscuous" anticancer drugs that hit multiple targets may thwart resistanceTracy Hampton
JAMA 292:419-22. 2004
- Investigational drugs for hepatitis CRobert Flisiak
Medical University of Bialystok, Department of Infectious Diseases and Hepatology, 15 540 Bialystok, Poland
Expert Opin Investig Drugs 19:63-75. 2010..Sustained virological response rate achieved with this standard of care medication is around 50% for HCV genotype 1, the most prevalent worldwide genotype. So there is an obvious need to enhance efficacy of treatment...
- Bioavailability and bioequivalence: an FDA regulatory overviewM L Chen
Office of Pharmaceutical Science, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20857, USA
Pharm Res 18:1645-50. 2001....
- Standardized order form for investigational drugs: effect on completeness of the prescriptionValérie Ollivier
Pharmacy Service, G Doumergue Hospital Medical Center, 5 rue Hoche, 30029 Nimes Cedex 9, France
Pharm World Sci 26:178-9. 2004..and quality of orders written before and after introduction of a preprinted medication order form for investigational drugs. Completeness of physician's orders for investigational drugs was compared during two successive periods: ..
- Developing a paradigm of drug innovation: an evaluation algorithmLuciano Caprino
Department of Human Physiology and Pharmacology, University La Sapienza, Rome, 00185, Italy
Drug Discov Today 11:999-1006. 2006..IAA provides a score of drug innovation by assessing information generated during both the pre-marketing and the post-marketing authorization phase...
- Pharmaceutical development of a parenteral lyophilized formulation of the investigational polymer-conjugated platinum anticancer agent AP 5280M Bouma
Department of Pharmacy and Pharmacology, Slotervaart Hospital The Netherlands Cancer Institute, Amsterdam, The Netherlands
Drug Dev Ind Pharm 29:981-95. 2003..The first clinical experiences indicate that the proposed formulation is fully applicable for use in the clinical setting...
- Magic shotguns versus magic bullets: selectively non-selective drugs for mood disorders and schizophreniaBryan L Roth
Department of Biochemistry, School of Medicine, Case Western Reserve University, 2109 Adelbert Road, Cleveland, Ohio 44106, USA
Nat Rev Drug Discov 3:353-9. 2004
- Technology evaluation: cantuzumab mertansine, ImmunoGenSuzanne V Smith
Australian Nuclear Science and Technology Organisation, Materials Engineering and Science, Menai, NSW 2234
Curr Opin Mol Ther 6:666-74. 2004..Cantuzumab mertansine is undergoing phase II trials for the potential treatment of CanAg-expressing cancers, including pancreatic and colorectal cancers and non-small-cell lung cancer...
- Emerging chemotherapeutic strategies for Huntington's diseaseHoon Ryu
Boston University School of Medicine, Edith Nourse Rogers Veterans Administration Medical Center, Bedford, Massachusetts 01730, USA
Expert Opin Emerg Drugs 10:345-63. 2005..These compounds are discussed herein...
- Lerisetron. FAESRichard Huckle
Axovan Ltd, Gewerbestrasse 16, 4123 Ailschwil, Switzerland
Curr Opin Investig Drugs 4:874-7. 2003..Phase I trials of lerisetron were underway in Spain by 1994, and as of June 2000, the compound was in phase II trials in the UK. By the end of 2001, phase II trials had been completed and phase III trials had commenced...
- Technology evaluation: ING-1, XOMALionel D Lewis
Section of Clinical Pharmacology, Dartmouth Hitchcock Medical Center and Dartmouth Medical School, Lebanon, NH 03756, USA
Curr Opin Mol Ther 5:433-6. 2003..In November 2000, ING-1 entered phase I trials in the US and by February 2002, phase I/II trials had been initiated...
- [Contact and dialogue between drug companies and the global regulatory authorities throughout research and development phase]Marianne Kock
Ugeskr Laeger 165:1649-52. 2003..The authority dialogue secures that authorities and companies exploit their resources optimally and patients get access to new, safe and efficacious drugs without delay...
- Inhibition of angiogenesis in cancer patientsHenk M W Verheul
Dept of Internal Medicine, University Medical Center, Utrecht, The Netherlands
Expert Opin Emerg Drugs 10:403-12. 2005..In combination with chemotherapy, other serious side effects, such as bleeding and thrombosis, also occur. Here, the preclinical and clinical data of antiangiogenic agents in clinical trials at this moment are summarised...
- Developing inhibitors of the epidermal growth factor receptor for cancer treatmentViktor Grünwald
The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD 21231 1000, USA
J Natl Cancer Inst 95:851-67. 2003....
- Research retreat: Pfizer eliminates Sugen, shrinks cancer infrastructureKen Garber
J Natl Cancer Inst 95:1036-8. 2003
- BMS-247550 Bristol-Myers Squibb/GBFNancy Lin
Division of Hematology and Oncology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA 02114, USA
Curr Opin Investig Drugs 4:746-56. 2003..By April 2002, phase I trials in children had also been initiated. As of May 2002, phase II studies had been conducted in patients with non-small-cell lung cancer and breast cancer...
- BAY-43-9006 Bayer/OnyxJohn T Lee
Department of Microbiology and Immunology, Brody School of Medicine, East Carolina University, East Fifth Street, Greenville, NC 27858 4553, USA
Curr Opin Investig Drugs 4:757-63. 2003..A US IND was filed in May 2000 and by February 2003 BAY-43-9006 was in phase II trials, with phase III trials expected to begin later in 2003...
- Arzoxifene Eli LillyCristina Marchisano-Karpman
University of California, Davis, Department of Internal Medicine, Division of Hematology Oncology, 4501 X Street Room 3016, Sacramento, CA 95817, USA
IDrugs 6:880-5. 2003..Arzoxifene is a benzothiophene second-generation selective estrogen receptor modulator (SERM) under development by Eli Lilly & Co as a potential treatment for cancer...
- Lapatinib ditosylate GlaxoSmithKlineTracy E Kim
449 S Doheny Drive, Beverly Hills, CA 90211, USA
IDrugs 6:886-93. 2003..Lapatinib ditosylate, an ErbB-2 and EGFR dual tyrosine kinase inhibitor, is being developed by GlaxoSmithKline plc for the potential treatment of solid tumors...
- Emerging drugs in cutaneous T-cell lymphomasReinhard Dummer
Department of Dermatology, University Hospital of Zurich, Gloriastrasse 31, CH 8091 Zurich, Switzerland
Expert Opin Emerg Drugs 10:381-92. 2005....
- Investigational drug access taken to task in lawsuit against FDAJudith Randal
J Natl Cancer Inst 95:1818-20. 2003
- The quest for surrogate markers of angiogenesis: a paradigm for translational research in tumor angiogenesis and anti-angiogenesis trialsCurzio Ruegg
Centre Pluridisciplinaire d Oncologie, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland
Curr Mol Med 3:673-91. 2003..Future anti-angiogenesis trials integrating biological endpoints and surrogate markers or angiogenesis will require close collaboration between clinical investigators and laboratory-based researchers...
- Accelerated approval of oncology products: a decade of experienceRamzi Dagher
Division of Oncology Drug Products, Center for Drug Evaluation and Research, U S Food and Drug Administration, 1451 Rockville Pike, Rockville, MD 20852, USA
J Natl Cancer Inst 96:1500-9. 2004....
- First International Symposium on Melanoma and Other Cutaneous MalignanciesAhmad A Tarhini
Division of Hematology Oncology, UPMC Cancer Pavilion, 5th Floor, 5150 Centre Avenue, Pittsburgh, PA 15232, USA
Expert Opin Biol Ther 4:1541-6. 2004..Sessions also included case-based learning and devoted ample time to providing 'how to' information for practising physicians...
- TLK-286Claire F Verschraegen
University of New Mexico, Cancer Research and Treatment Center, 900 Camino de Salud NE, Albuquerque 87131, USA
IDrugs 7:771-81. 2004..Telik Inc is developing TLK-286, a modified glutathione analog prodrug, for the potential treatment of cancer...
- New drugs in cancer therapy, National Tumor Institute, Naples, 17-18 June 2004Francesco Caponigro
National Tumor Institute, Fondazione G Pascale, Naples, Italy
Anticancer Drugs 16:211-21. 2005..Phase I/II clinical trials have shown low toxicity and evidence of anti-tumor activity; on the other hand, this compound has potential for synergism with radiotherapy, chemotherapy and biologicals...
- [Urogenital cancer studies in view of new legislation]D Rohde
Arbeitsgemeinschaft Urologische Onkologie, Urologische Klinik, Klinikum, Darmstadt
Urologe A 44:294-6. 2005..Therefore, two pharmaceutical hearings took place at the University of Frankfurt...
- Antitumor efficacy testing in rodentsMelinda G Hollingshead
Biological Testing Branch, Developmental Therapeutics Program, Fairview Center, Frederick, MD 21701, USA
J Natl Cancer Inst 100:1500-10. 2008..Improved preclinical selection criteria can aid in reducing unnecessary human studies, thus reducing the overall costs of anticancer drug development...
- Heat-shock protein 90 inhibitors as novel cancer chemotherapeutics - an updateLen Neckers
National Cancer Institute, Urologic Oncology Branch, 9610 Medical Ctr, Suite 300, Rockville, MD 20850, USA
Expert Opin Emerg Drugs 10:137-49. 2005..Other Hsp90 inhibitors are either in Phase I clinical trial or under development. This update will focus on how the latest developments in Hsp90 biology may better inform the clinical development of Hsp90 inhibitors...
- Emerging analgesics in cancer pain managementLukas Radbruch
University of Aachen, Department of Palliative Medicine, Pauwelsstrasse 30, 52074 Aachen, Germany
Expert Opin Emerg Drugs 10:151-71. 2005....
- Drug development and the heart hospitalJay H Kleiman
Division of Cardiovascular Metabolic Research, Pharmacia Corporation, Lake Forest, IL 60045, USA
Am Heart Hosp J 1:188-91. 2003..Meticulous attention to patient safety and privacy, good clinical practice, and high-quality data collection are imperative...
- New, expanded, and modified use of approved antineoplastic agents in ovarian cancerMaurie Markman
Department of Gynecologic Medical Oncology, University of Texas M D Anderson Cancer Center Mail Box 121, 1515 Holcombe Boulevard, Houston, Texas 77030, USA
Oncologist 12:186-90. 2007..g., gemcitabine, docetaxel, etoposide, irinotecan, vinorelbine, and bevacizumab). It can be anticipated that future studies involving novel approved agents will further expand the oncologist's weapons against ovarian cancer...
- Obstacles and opportunities in new drug developmentK I Kaitin
Tufts Center for the Study of Drug Development, Tufts University School of Medicine, Boston, Massachusetts, USA
Clin Pharmacol Ther 83:210-2. 2008
- MEN-10755. MenariniKellie Jones
University of Texas MD Anderson Cancer Center, Department of Pharmacy, 1515 Holcombe Boulevard, Houston, TX 77030, USA
Curr Opin Investig Drugs 4:1473-8. 2003..Six phase II trials began in 2000 to verify the therapeutic activity of the drug in a variety of tumors, including sarcoma and those of the ovary, breast, prostate and lung...
- ZD-6126 AstraZenecaJens Soltau
Tumor Biology Center, Department of Medical Oncology, Breisacher Strasse 117, 79106 Freiburg, Germany
IDrugs 7:380-7. 2004..AstraZeneca is developing ZD-6126, one of the ANG-400 series of vascular-targeting and tubulin-binding agents under license from Angiogene Pharmaceuticals Ltd, for the potential treatment of cancer...
- Statistical inference for cancer trials with treatment switchingJun Shao
University of Wisconsin, Madison, WI 53706, USA
Stat Med 24:1783-90. 2005..Statistical inference procedures under both models are provided. A simulation study is performed to investigate the performance of the proposed methods...
- Pediatric clinical trial experience: government, child, parent and physician's perspectiveJuan C Salazar
Department of Pediatrics, University of Connecticut Medical School, Hartford, USA
Pediatr Infect Dis J 22:1124-7. 2003..Although children now have access to new medicines during the development process, their participation in clinical trials must still protect them from undue risk and secure their well being...
- Good drug, bad luck: business, regulatory issues can create obstacles for drug developmentBruce Goldman
J Natl Cancer Inst 96:1573-4. 2004
- [New drugs and European procedures of approval. The European Agency for the Evaluation of Medicinal Products' role]Mark A Ainsworth
Afdeling for Laegemiddelgodkendelse, Laegemiddelstyrelsen, Frederikssundsvej 378, DK 2700 Brønshøj
Ugeskr Laeger 165:1648-9. 2003..As a large proportion of clinical drug trials is sponsored by industry and aims at obtaining regulatory approval, the guidance provided by EMEA will have increasing influence on clinical drug research in Europe...
- Preclinical and clinical development of novel agents that target the protein kinase C familyMaria Serova
U716, Hopital Saint Louis, Paris, France
Semin Oncol 33:466-78. 2006....
- The role of the National Cancer Institute in drug developmentJames Doroshow
Division of Cancer Treatment and Diagnosis, National Cancer Institute, MD, USA
Clin Adv Hematol Oncol 3:257-8. 2005
- Antisense oligonucleotides: the state of the artT aboul-Fadl
Department of Pharmaceutical Medicinal Chemistry, Faculty of Pharmacy, Assiut University, Assiut, Egypt
Curr Med Chem 12:2193-214. 2005..This review outlines the basic concept of the antisense technology, its development and recent potential therapeutic applications...
- Preclinical predictors of clinical safety: opportunities for improvementF D Sistare
Safety Assessment, Merck and Co Inc, West Point, Pennsylvania, USA
Clin Pharmacol Ther 82:210-4. 2007....
- Drug development process for a product with a primary pediatric indicationAlbert J Allen
Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, USA
J Clin Psychiatry 63:44-9. 2002....
- Age disparity between a cancer population and participants in clinical trials submitted as a new drug application of anticancer drugs in JapanAkiko Hori
Office of New Drug I, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan
Cancer 109:2541-6. 2007..Underrepresentation of older patients in cancer clinical trials has been reported previously...
- Development of novel anticancer agents in older patients: pharmacokinetic, pharmacodynamic, and other considerationsAnthony J Murgo
National Cancer Institute, National Institutes of Health, Rockville, Maryland 20852, USA
Cancer J 11:481-7. 2005..Furthermore, data obtained from studies in older patients may provide valuable information applicable to the development of novel agents in younger patients and to a better understanding of cancer biology and treatment in general...
- Cancer drugs. Weighing the risks and benefitsLinda Bren
FDA Consum 41:10-9. 2007..Few deliberations have greater bearing on human health than when the Food and Drug Administration weighs the risks and benefits of drugs designed to treat life-threatening diseases, such as cancer...
- Promoting, improving and accelerating the drug development and approval processesA I Graul
Drug News Perspect 20:45-55. 2007..This article reviews the three programs and provides a capsule view of new developments in these vital areas during the year 2006...
- Safety biomarkers and the clinical development of oncology therapeutics: considerations for cardiovascular safety and risk managementHoward Fingert
Pfizer Global Research and Development, 50 Pequot Ave B4258, New London, CT, USA
AAPS J 8:E89-94. 2006....
- Investigational treatments for multiple myelomaSara Bringhen
Divisione di Ematologia dell Universita di Torino, Azienda Ospedaliera San Giovanni Battista, Via Genova 3, 10126 Torino, Italy
Expert Opin Investig Drugs 15:1565-82. 2006..Their mechanisms of action, the available knowledge on their efficacy, safety and possible future clinical application are reviewed...
- Discontinued drugs in 2005: pulmonary-allergy, dermatological, gastrointestinal and arthritis drugsKenneth K C Lee
School of Pharmacy, Faculty of Medicine, Chinese University of Hong Kong, Shatin, NT, Hong Kong, China
Expert Opin Investig Drugs 15:1497-505. 2006..A survey of discontinued drugs from 2005 is provided, based on data from the Pharmaprojects database, along with an analysis of economic considerations in developing new drugs...
- Restricted treatments, inducements, and research participationSarah J L Edwards
Centre for Bioethics and Philosophy of Medicine UCL, Research and Development Directorate, University College London Hospitals NHS Trust, London W1P 9LL, UK
Bioethics 20:77-91. 2006..Some participants may therefore be exploited for scientific purposes in the name of public interest. There are nonetheless compelling reasons for keeping some restrictive regulation in this area...
- Investigational PPAR-gamma agonists for the treatment of Type 2 diabetesRajesh S Savkur
Eli Lilly and Company, Diabetes Research, Lilly Research Laboratories, Indianapolis, IN 46285, USA
Expert Opin Investig Drugs 15:763-78. 2006..This review focuses on the currently marketed compounds and also describes the discovery and development of the next generation of PPAR ligands that are under investigation for the potential treatment of T2D and the metabolic syndrome...
- Pegylated arginine deiminase: a novel anticancer enzyme agentLynn Feun
University of Miami, Sylvester Comprehensive Cancer Center, 1475 Northwest 12th Avenue, Miami, FL 33136, USA
Expert Opin Investig Drugs 15:815-22. 2006..Large Phase II trials and randomised, controlled Phase III trials are needed to determine its overall efficacy in the treatment of these malignancies and others...
- Anticancer carrier-linked prodrugs in clinical trialsFelix Kratz
Tumor Biology Center, Macromolecular Prodrugs, Freiburg, Germany
Expert Opin Investig Drugs 16:1037-58. 2007..This review summarizes the Phase I-III studies that have been performed with these macromolecular prodrugs...
- Emerging drugs for ovarian cancerLloyd R Kelland
Antisoma Research Laboratories, St Georges Hospital Medical School, Cranmer Terrace, London, SW17 0QS, UK
Expert Opin Emerg Drugs 10:413-24. 2005..g., 5,6-dimethyl xanthenone 4-acetic acid). At the pre-clinical level, agents being developed to target the phosphatidylinositol 3 kinase/AKT/mTOR pathway, and K-Ras inhibitors, may offer efficacy in the future...
- Business barriers slowing the pace of cancer immunotherapy research and developmentRabiya S Tuma
J Natl Cancer Inst 99:1570-3. 2007
- Antibody World Summit 2007--SRI's Sixth Annual Meeting. Discovery & development/manufacturing & processing. 16-17 July 2007, New Brunswick, NJ, USAK John Morrow
Newport Biotechnology Consultants, 625 Washington Avenue, Newport, KY 41071, USA
IDrugs 10:686-9. 2007
- Heat-shock protein 90 inhibitors in antineoplastic therapy: is it all wrapped up?Jennifer S Isaacs
Urologic Oncology Branch, Center for Cancer Research, NCI, National Institutes of Health, Rockville, MD, USA
Expert Opin Investig Drugs 14:569-89. 2005..Elucidation of these nuances will undoubtedly lead to better targeting of relevant oncogenic pathways and translate into the development of more effective anticancer regimens...
- The review of drug applications submitted to the European Medicines Evaluation Agency: frequently raised objections, and outcomeFrancesco Pignatti
Safety and Efficacy, Oncology, European Agency for the Evaluation of Medicinal Products, 7 Westferry Circus, Canary Wharf, London E14 4HB, UK
Eur J Clin Pharmacol 58:573-80. 2002..To study the issues raised during the review of drug applications submitted to the European Medicines Evaluation Agency for approval in the European Union and to identify important predictors of outcome...
- Use of genotoxicity data to support clinical trials or positive genetox findings on a candidate pharmaceutical or impurity .... now what?David Jacobson-Kram
Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20852, USA
Int J Toxicol 24:129-34. 2005..In addition, this paper discusses factors to consider when setting limits for genotoxic impurities in drug substances and products...
- New paradigm in dose-finding trials: patient-specific dosing and beyond phase IAndre Rogatko
Winship Cancer Institute, Atlanta, Georgia 30322, USA
Clin Cancer Res 11:5342-6. 2005..These examples should be interpreted as an enticement for the development of new methods to implement the proposed new paradigm...
- Conflicting signals on US accelerated approvalsJeffrey L Fox
Nat Biotechnol 23:1027-8. 2005
- Emerging drugs for adult acute lymphoblastic leukaemiaXavier Thomas
Department of Hematology, Edouard Herriot Hospital, Lyon, France
Expert Opin Emerg Drugs 10:591-617. 2005..With a better understanding of the disease, more target-specific therapies could be designed. The aim of this review is to highlight new pharmacotherapies and those emerging drug treatments for patients with adult ALL...
- Novel agents and strategies to treat herpes simplex virus infectionsGerald Kleymann
Expert Opin Investig Drugs 12:165-83. 2003..This review summarises the current therapeutic options, discusses the potential of preclinical or investigational drugs and provides an up-to-date interpretation of the challenge to establish novel treatments for herpes ..
- Informed consent and investigational new drug abuses in the U.S. militaryMary L Cummings
Systems Engineering, University of Virginia, PO Box 400747, Charlottesville, VA 22904 4747, USA
Account Res 9:93-103. 2002..was to research the ethical issues surrounding the military's requests for informed consent waivers when using investigational drugs, and the recent debate surrounding the anthrax vaccine as an investigational new drug (IND).
- Old and new antiarrhythmic drugs for converting and maintaining sinus rhythm in atrial fibrillation: comparative efficacy and results of trialsGerald V Naccarelli
Division of Cardiology and the Penn State Cardiovascular Center, Penn State University College of Medicine, The Milton S Hershey Medical Center, Hershey, Pennsylvania 17033, USA
Am J Cardiol 91:15D-26D. 2003..Recently approved antiarrhythmics, such as dofetilide, and promising investigational drugs, such as azimilide and dronedarone, may change the treatment landscape for AF...
- [A randomized, controlled, double-blind trial of Huannao Yicong capsule in senile patients with mild cognitive impairment]Hao Li
Department of Geriatrics, China Academy of Chinese Medical Sciences, Beijing 100091, China
Zhong Xi Yi Jie He Xue Bao 6:25-31. 2008..To observe the effect and explore the mechanism of Huannao Yicong capsule in treating senile patients with mild cognitive impairment (MCI)...
- Clinical, double-blind, placebo-controlled study investigating the combination of acetylsalicylic acid and pseudoephedrine for the symptomatic treatment of nasal congestion associated with common coldIrene Loose
Bayer HealthCare AG, Consumer Care EU, R and D Medical Affairs, Leverkusen, Germany
Arzneimittelforschung 54:513-21. 2004..The investigational drugs ASA and PSE were both provided as granules in sachets and the granules were dissolved in water before ..
- Handling of gene-transfer products by the National Institutes of Health Clinical Center pharmacy departmentH J DeCederfelt
Pharmacy Department, Warren Grant Magnuson Clinical Center WGMCC, National Institutes of Health, Bethesda, MD 20892 1196, USA
Am J Health Syst Pharm 54:1604-10. 1997..will be required are prepared in advance; the worksheets are part of a drug fact sheet prepared for all investigational drugs dispensed. Personnel must be properly trained and dressed in protective clothing...
- Purine nucleoside analogues in the treatment of myleoid leukemiasTadeusz Robak
Department of Hematology, Medical University of Lodz, 93 513 Lodz, Pabianicka 62 Poland
Leuk Lymphoma 44:391-409. 2003..An alternative approach to increase FLAG activity might be the addition of investigational drugs with novel mechanism of action, such as topoiromerase I inhibitors...
- A randomized clinical trial of alpha(1)-antitrypsin augmentation therapyA Dirksen
Department of Respiratory Medicine, The Rigshospital, Copenhagen, Denmark
Am J Respir Crit Care Med 160:1468-72. 1999..We conclude that lung density measurements by CT may facilitate future randomized clinical trials of investigational drugs for a disease in which little progress in therapy has been made in the past 30 yr.
- Investigational medications for treatment of patients with Alzheimer diseasePamela E Potter
Department of Pharmacology, Midwestern University Arizona College of Osteopathic Medicine, Glendale, Arizona 85308 6813, USA
J Am Osteopath Assoc 110:S27-36. 2010..Results of clinical trials with many of these investigational drugs have been disappointing, perhaps because of their use with patients in advanced stages of Alzheimer ..
- Primary porcine enterocyte and hepatocyte cultures to study drug oxidation reactionsA Bader
Leibniz Research Laboratories for Biotechnology and Artificial Organs, Forschungszentrum der MHH, Podbielskistr 380, D 30659, Hannover, Germany
Br J Pharmacol 129:331-42. 2000..organ differences in the metabolism of the immunosuppressive compound tacrolimus (FK 506) and of two investigational drugs (KC11346 and KC12291)...
- Drug-induced hypersensitivity: role in drug developmentHelen V Ratajczak
Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, Connecticut, USA
Toxicol Rev 23:265-80. 2004..It is important that investigational drugs with the potential to produce hypersensitivity reactions be identified as early in the development process ..
- Action of anti-HIV drugs and resistance: reverse transcriptase inhibitors and protease inhibitorsTomozumi Imamichi
Applied and Development Research Program, National Institute of Allergy and Infectious Diseases at Frederick, Science Applications International Corporation Frederick, Inc, Frederick, MD 21702, USA
Curr Pharm Des 10:4039-53. 2004..At present, several investigational drugs are being tested in clinical trials...
- Estimation of the interindividual variability of cytochrome 2D6 activity from urinary metabolic ratios in the literatureTakashi Ito
Drug Metabolism and Pharmacokinetics Research Laboratories, R and D Division, Daiichi Sankyo Co Ltd, Shinagawa R and D Center, 1 2 58 Hiromachi, Shinagawa ku, Tokyo, Japan
Drug Metab Pharmacokinet 25:243-53. 2010..The present study should be useful for predicting the interindividual variability in exposure to investigational drugs that are metabolized by CYP2D6.
- Investigational therapies in the treatment of obesityMarcio C Mancini
Sao Paulo University, Obesity and Metabolic Syndrome Group of the Endocrinology and Metabology Service, Faculty of Medicine, Hospital das Clinicas, Sao Paulo, Brazil
Expert Opin Investig Drugs 15:897-915. 2006..b>Investigational drugs stimulating catabolic pathways consist of leptin, agonists of melanocortin receptor-4, 5-HT and dopamine; ..
- Primary eosinophilic disorders: a concise reviewAnimesh Pardanani
Division of Hematology, Mayo Clinic, Rochester, MN 55905, USA
Curr Hematol Malig Rep 3:37-43. 2008..with HES who are refractory to usual therapy and have life-threatening disease complications, the use of investigational drugs such as alemtuzumab or mepolizumab might be considered, but data on long-term efficacy and safety are ..
- Analysis of information submitted by clinical trial sponsors regarding the safety of investigational drugsRisa Takayanagi
Department of Pharmacy, The University of Tokyo Hospital, Faculty of Medicine, The University of Tokyo, Japan
Yakugaku Zasshi 124:225-9. 2004During performance of clinical trials in medical institutions, information regarding the safety of investigational drugs is submitted by trial sponsors according to guidelines for good clinical practice...
- Antiviral L-nucleosides specific for hepatitis B virus infectionM L Bryant
Novirio Pharmaceuticals, Inc, Cambridge, Massachusetts 02140, USA
Antimicrob Agents Chemother 45:229-35. 2001..These investigational drugs, used alone or in combination, are expected to offer new therapeutic options for patients with chronic HBV ..
- Headache and the human immunodeficiency virus type 1 infectionR G Holloway
University of Rochester (NY) School of Medicine and Dentistry, USA
Headache 35:245-55. 1995..need to be alert and adaptable when assessing HIV-infected individuals with headache since multiple causes can exist in the same patient and new syndromes, complications, and investigational drugs are continually being identified.
- Access to investigational medicinal products for minors in Europe: ethical and regulatory issues in negotiating children's access to investigational medicinesWim Pinxten
Katholieke Universiteit Leuven, Centre for Biomedical Ethics and Law, Leuven, Belgium
J Med Ethics 36:791-4. 2010..The paper concludes with a concise reflection on the way forward. The quest for access to investigational drugs is particularly relevant to paediatric practice, in which a significant share of the drugs prescribed has ..
- [Documents for clinical trials of new drugs: results of their reviews prior to submissions to IRB]Risa Takayanagi
Department of Pharmacy, University of Tokyo Hospital, Faculty of Medicine, University of Tokyo, 7 3 1 Hongo, Bunkyo ku, Tokyo 113 8655, Japan
Yakugaku Zasshi 123:249-54. 2003..Among them, 325 (34.0%) were related to the profile/description of investigational drugs themselves, and 252 (26.4%) were related to the trial plan...
- Agents and strategies in development for improved management of herpes simplex virus infection and diseaseGerald Kleymann
Expert Opin Investig Drugs 14:135-61. 2005..This review summarises the current therapeutic options, discusses the potential of preclinical or investigational drugs and provides an up-to-date interpretation of the challenge to establish novel treatments for herpes ..
- New prognostic scoring system for primary myelofibrosis based on a study of the International Working Group for Myelofibrosis Research and TreatmentFrancisco Cervantes
Hematology Department, Hospital Clinic, Institut d Investigacions Biomediques August Pi i Sunyer, University of Barcelona, Barcelona, Spain
Blood 113:2895-901. 2009..is becoming more challenging because of the increasing use of allogeneic stem cell transplantation and new investigational drugs. To enhance this process by developing a highly discriminative prognostic system, 1054 patients ..
- Investigational drug tracking: Phases I-III and NDA submissions--Part IK L Grant
Drug and Poison Information Center, University of Wisconsin Hospital and Clinics, Madison
Hosp Pharm 29:830-6, 839-44, 847-52 passim. 1994The author catalogs over 800 investigational drugs/biologicals currently in Phase I, II or III clinical trials or drugs/biologicals submitted to the FDA as new drug applications...
- Moving beyond interferon alfa: investigational drugs for hepatitis C virus infectionDavid L Wyles
University of California San Diego, La Jolla, CA, USA
Top HIV Med 18:132-6. 2010....
- The systemic treatment of onychomycosisJay A Wenig
Clin Podiatr Med Surg 21:579-89, vi. 2004..Direct-to-the-public advertising has raised interest in patients to seek treatment. There are also some new investigational drugs for fungal infections that may augment or supplant current therapy.
- Advances in Aurora kinase inhibitor patentsMohane Selvaraj Coumar
Division of Biotechnology and Pharmaceutical Research, Zhunan Town, Miaoli County 350, Taiwan, ROC
Expert Opin Ther Pat 19:321-56. 2009..Hence, the use of Aurora kinase small-molecule inhibitors as a potential molecular-targeted therapeutic intervention for cancer is being pursued...
- [Survey of the attitude of master course students of clinical pharmacy toward clinical trials]Risa Takayanagi
Department of Clinical Drug Evaluation, School of Pharmacy, Tokyo University of Pharmacy and Life Science, Horinouchi, Hachioji City, Japan
Yakugaku Zasshi 126:515-20. 2006..On the other hand, over 92% thought that pharmacists should manage investigational drugs and provide information on those drugs for the rational conduct of clinical trials...
- Outbreak of hospital-adapted clonal complex-17 vancomycin-resistant Enterococcus faecium strain in a haematology unit: role of rapid typing for early controlA Deplano
Department of Microbiology, Erasme Hospital, Universite Libre de Bruxelles, Brussels, Belgium
J Antimicrob Chemother 60:849-54. 2007..To describe the investigation and molecular characterization of a vancomycin-resistant Enterococcus faecium (VREF) strain responsible for a nosocomial outbreak in the haematology unit of a tertiary-care university hospital...
- Registered and investigational drugs for the treatment of methicillin-resistant Staphylococcus aureus infectionAngelo Pan
Divisione di Malattie Infettive, Istituti Ospitalieri di Cremona, Cremona, Italy
Recent Pat Antiinfect Drug Discov 3:10-33. 2008....
- Valid treatment options for osteoporosis and osteopenia in HIV-infected personsPatrick G Clay
Dybedal Center for Clinical Research, Kansas City University of Medicine and Biosciences, Kansas City, MO 64106, USA
Ann Pharmacother 42:670-9. 2008..To review clinical data on bone ossification agents that may be considered for use in the treatment of osteoporosis and osteopenia in HIV-infected patients...
- Anti-HBV specific beta-L-2'-deoxynucleosidesM L Bryant
Novirio Pharmaceuticals, Inc, 125 Cambridge Park Dr, Cambridge, Massachussetts 02476, USA
Nucleosides Nucleotides Nucleic Acids 20:597-607. 2001..Plasma viremia is reduced up to 8 logs in a woodchuck model of chronic HBV infection. These investigational drugs, used alone or in combination, are expected to offer new therapeutic options for patients with chronic HBV ..
- Phase I Study in Patients Supporting IV TPM for Neonatal Seizures (9/07, IND7899)James Cloyd; Fiscal Year: 2009..Prior to studies of investigational drugs in newborns, the Food and Drug Administration (FDA) requires that studies first be done in adults...
- The 50th Annual Meeting of the American Society of PharmacognosyBill J Baker; Fiscal Year: 2010..Among the important natural products which are in use in the clinic or which are investigational drugs are taxol, etoposide, topotecan/irinotecan, the halichondrin analog E7389, dolastatin derivatives, the ..
- Concurrent HAART and Tuberculosis Treatment: Drug to Drug InteractionsAWEWURA JACOB KWARA; Fiscal Year: 2010..molecular and clinical models to identify and predict drug interactions involving antiretroviral agents will allow for targeted PK studies of current and investigational drugs relevant to the clinical management of HIV in TB patients.
- TCH/BCM Pediatric Pharmacology Research UnitDavid Poplack; Fiscal Year: 2009..a locus for the Conduct of studies in all aspects of pediatric pharmacology, from preclinical studies of investigational drugs to safety and efficacy studies of drugs already marketed...
- TAS::75 0849::TAS THE CONTRACTOR PROPOSES TO DEVELOP IN VIVIO COMPATIBLE AND REAWYNN VOLKERT; Fiscal Year: 2010..formulation of NBI-29 to meet the standards of safety, identity, strength, quality and purity required for investigational drugs;(ii) determination of the biodistribution and radiation dose delivered to normal organs from NBI-29 ..
- Determining Therapeutic Efficacy of AGE in ADNeelima Chauhan; Fiscal Year: 2005..Current investigational drugs include Xanthine derivatives-Propentofylline and cholesterol-lowering agents [HMG-CoA reductase inhibitors-..
- Response Therapies for MDR-TBIan M Orme; Fiscal Year: 2010..Several promising lead compounds as well new investigational drugs such as PA-824 have recently been tested at CSU and will be explored further in this program against MDR ..
- Transfusion Medicine/Hemostasis Clinical Research NetworkRonald G Strauss; Fiscal Year: 2012..Therapeutic trials have involved the use of investigational drugs or blood products, including those already approved and used, as well as those not currently used...
- Community Clinical Oncology Program: FL Pediatric CCOPJames L Talbert; Fiscal Year: 2013..It provides access to protocols, investigational drugs, quality assurance review and an opportunity to participate in cutting edge research that is not available ..
- Novel Therapies in Hemostasis and TransfusionJAMES BRUCE BUSSEL; Fiscal Year: 2012..emphasize clinical trials to facilitate optimal therapy, and conduct therapeutic trials researching investigational drugs or blood products...
- Drug Repurposing using Pharmacological NetworksMICHAEL JAMES KEISER; Fiscal Year: 2010..SEA may thus be applied systematically and comprehensively, querying all target classes with all drugs and investigational drugs. We will therefore predict all likely off-targets for all 3665 FDA, worldwide and investigational drugs, ..
- A platform to predict side-effect targets for drugsMICHAEL JAMES KEISER; Fiscal Year: 2013..This will be done comprehensively across all approved and investigational drugs, all accessible targets, and all adverse reactions for which targets may be associated...
- Parenteral Formulations for Synthetic RetinoidsRalph Parchment; Fiscal Year: 2001SciTech LLC develops novel intravenous (IV) formulations for investigational drugs with poor physical properties...
- Human Subjects Research Enhancements Program, Year 2Nancy King; Fiscal Year: 2003..4. Web-based Training: Managing Investigational Drugs. Building on a new policies and procedures, KFRI proposes to develop an on-line tutorial designed to ..
- SYNTHESIS OF CONGENERS & PRODRUGS OF ANTI-AIDS COMPOUNDSWayne Anderson; Fiscal Year: 1990..The contractor is responsible for receiving shipments of investigational drugs for use in clinical trials, from a variety of pharmaceutical manufacturers and packagers throughout the U...
- CANCER IN CHILDRENJames Whitlock; Fiscal Year: 2002..5. Through committee participation, contribute to the development and analyses of investigational drugs. 6...
- NOVEL ACTIONS OF INVERSE AGONISTSWilliam Clarke; Fiscal Year: 2002..Since many therapeutic and investigational drugs that were previously thought to be antagonists have recently been demonstrated (or are suspected) to be ..
- DRUG MANAGEMENT SOFTWARE FOR NCI CLINICAL TRIALSStephen Burke; Fiscal Year: 2000..awarded a Phase I SBIR contract to create an algorithmic computer model which inventories and tracks all investigational drugs used in NCI-sponsored clinical trials...
- Modification of daptomycin by combinatorial biosynthesisPaul Brian; Fiscal Year: 2005..is produced by the Gram-positive bacterium Streptomyces roseosporus and is the first in a new class of investigational drugs called lipopeptides that is being developed by Cubist for the treatment of serious and life-threatening ..
- Modification of daptomycin by combinatorial biosynthesisPaul Brian; Fiscal Year: 2003..is produced by the Gram-positive bacterium Streptomyces roseosporus and is the first in a new class of investigational drugs called lipopeptides that is being developed by Cubist for the treatment of serious and life-threatening ..
- PEDIATRIC PHARMACOLOGY RESEARCH UNITDavid Poplack; Fiscal Year: 2003..pharmacokinetics, pharmacodynamics, and the safety and efficacy of both commercially available and investigational drugs. An important focus of the CPG is to conduct preclinical and clinical studies aimed at increasing ..
- PEDIATRIC ONCOLOGY GROUPYaddanapudi Ravindranath; Fiscal Year: 2002..are able to share new information and ideas and gain access to new multimodal therapy regimens and investigational drugs which hopefully provide the best available care to these children...
- NSABP MEMBER--UNIVERSITY OF KENTUCKYEdward Romond; Fiscal Year: 2000..In July 1994 an Investigational Drug Pharmacy was established to receive and control investigational drugs and to assure that all investigational and study drugs used will be handled appropriately.
- SACRAMENTO COMMUNITY CLINICAL ONCOLOGY PROGRAMVincent Caggiano; Fiscal Year: 1992..through sound data management, physician involvement in quality control efforts, careful management of investigational drugs and annual reviews of physician participation...
- Dosing & safety trials using csA in severe head injuryALFRED YOUNG; Fiscal Year: 2003..to guide dosing for specific pharmacodynamic endpoints is one of several possible reasons for failure of investigational drugs to demonstrate benefit...
- DRUG MANAGEMENT SOFTWARE FOR NCI CLINICAL TRIALSStephen Burke; Fiscal Year: 1999..of this software, it became apparent that a major gap existed in their ability to monitor and track investigational drugs related to handling, inventory, and patient use...
- SOUTHWEST ONCOLOGY GROUPFRANCIS MORRISON; Fiscal Year: 1980..Patients to be studied are adults with hematologic malignancy or solid tumor. They will be treated with investigational drugs, or investigational combination drug protocols developed by the principal investigator, his associates, or ..
- EASTERN COOPERATIVE ONCOLOGY GROUPMartin Oken; Fiscal Year: 1980..The major tool of investigation by ECOG is the well-designed clinical protocol. Investigational drugs for these studies are made available to the National Cancer Institute...
- HTS Molecules Targeting APP 5'untranslated Region(RMI)Jack Rogers; Fiscal Year: 2007..abstract_text> ..
- MLSN Screen of the PD Alpha Synuclein 5'UTRJack Rogers; Fiscal Year: 2008..Compounds directed to 5'UTRs of other mRNAs will probe mechanism of translation of the Abeta-amyloid precursor protein mRNA in Alzheimer's disease (SOD-1 mRNA in ALS, and PrP mRNA in Cruetzsfeld- Jacob Syndrome). [unreadable]..
- ANTIAIDS AGENTS FROM MARINE ORGANISMSMark Hamann; Fiscal Year: 2007....
- APPROACHES TO CHARACTERIZATION OF ANTIINFECTIVE AGENTSMark Hamann; Fiscal Year: 2002..SAR studies will be conducted utilizing chemical and microbial transformations of biologically active secondary metabolites combined with molecular modeling studies. ..
- NON-PROTEIN AMINO ACIDS AND TAXOID ANTITUMOR AGENTSIwao Ojima; Fiscal Year: 2002..Drug resistance in cancer chemotherapy is a serious problem. In order to solve this problem, the PI will continue his successful approach to the development of MDR reversal agents based on the strategic modification of baccatins. ..
- Apoptosis in myelofibrosis with myeloid metaplasiaRuben Mesa; Fiscal Year: 2006..abstract_text> ..
- RNA Therapeutics and Abeta Precursor Protein TranslationJack Rogers; Fiscal Year: 2006..Small molecules could well act by this pathway to decrease APP synthesis and concomitant ABeta-peptide output. ..
- NEW SYNTHESIS OF BIOCHEMICALS WITH HOMOGENEOUS CATALYSTSIwao Ojima; Fiscal Year: 2003..In this project, we plan to develop new synthetic routes to a variety of enantiopure heterocyclic and carbocyclic compounds of medicinal interest featuring diastereoselective or enantioselective catalytic processes as the key steps. ..
- STIMULANT DEPENDENCE: NEURAL MECHANISMS OF RELAPSEMartin Paulus; Fiscal Year: 2008..This project will link systems neuroscience with clinical research in substance use disorders thereby providing cognitive neuroscience and neuroimaging insights into dysfunctions associated with substance use disorders. ..
- Metalloproteinases in Tumor Progression and MetastasisJeffrey Smith; Fiscal Year: 2009..These chemical leads will be improved by iterative structure-based modifications and will be tested in cell-based assays and ultimately in animal models of tumor progression. ..
- Regulating fibrocyte differentiation in fibrosisRichard H Gomer; Fiscal Year: 2009....
- Molecular and Cellular Characterization of Myeloproliferative DiseaseKATHLEEN MIHO SAKAMOTO; Fiscal Year: 2010..These studies will provide new insights into the molecular pathways leading to MPD. ..
- COGNITIVE BEHAVIOR THERAPY OF ADOLESCENT SOCIAL PHOBIAJames Herbert; Fiscal Year: 2001..It is predicted that both group-CBT and individual-CBT will be more effective than E/SP, and that treatment gains will be maintained through the follow-up period. ..
- NEUROBIOLOGY OF TRANSITION TO STIMULANT DEPENDENCEMartin P Paulus; Fiscal Year: 2010..g. using real-time fMRI?? ..
- Galanin Control of Food Intake: Molecular, Neuroanatomical and Behavioral BasesEric P Zorrilla; Fiscal Year: 2010....
- EFFECTS OF STATINS ON PULMONARY HYPERTENSIONReda Girgis; Fiscal Year: 2007..This award will allow the candidate to develop into a well-trained independent researcher in PH. ..
- DNA Tolerizing Vaccine Therapy for Multiple SclerosisHideki Garren; Fiscal Year: 2002..S. FDA for the evaluation of a DNA tolerizing vaccine in a phase I clinical trial. ..
- DISINTEGRINS & METALLOPROTEINASES IN ORTHOPEDIC DISEASEJeffrey Smith; Fiscal Year: 2002..Homology-based PCR will be used to clone osteoclast ADAMs. Antibodies against these ADAMs will be used in attempts to block osteoclast differentiation. ..
- Phase ii intraperitoneal rhIL 12Ralph Freedman; Fiscal Year: 2002..4) Determine whether expression of proangiogenic factors VEGF, FGF2 and IL-8 are decreased following IF rhIL- 12. ..
- Applied Biosystems QStar Pulsar I with oMALDI SourceJeffrey Smith; Fiscal Year: 2003..The acquisition of the Q-Star instrument will enhance the Burnham Institute's broad, long-term effort of supporting and enabling world-class science at the interface of biology and mass spectrometry. ..
- BLADDER CANCER BIOMARKERS GUIDES TO SURGERY AND THERAPYRobert Hurst; Fiscal Year: 2003..The results of this study should generate biomarker profiles that are based in basic, mechanistic understanding of metastasis that can subsequently be tested in controlled clinical studies. ..
- Urothelial cell response to bacterial infectionRobert Hurst; Fiscal Year: 2004..These data will form an essential element in either an R01 or a program project and will permit the PI to develop a new line of urologic research. ..
- Anti-idiotypic immune regulation by T cell vaccinationJingwu Zhang; Fiscal Year: 2004..The long-term goal of the study is to define the mechanism of T cell vaccination and develop a practical peptide-based vaccination approach. ..
- Molecular Modulation of Cardiac Na+ Channel FunctionKatherine Murray; Fiscal Year: 2004..abstract_text> ..
- Host genes required for P. aeruginosa pathogenesisVincent Lee; Fiscal Year: 2004..abstract_text> ..
- Bleomycin Hydrolase and Alzheimer's DiseaseJOHN LAZO; Fiscal Year: 2004..These studies should provide new mechanistic information concerning the pathogenesis of AD as well as reagents for future therapeutic studies. ..
- MOLECULAR REGULATION OF D1 DOPAMINE RECEPTOR FUNCTIONRichard Mailman; Fiscal Year: 2004..These studies of beta-arrestin binding and recruitment will provide another functional endpoint in the delineation of the molecular mechanisms of D1 receptor desensitization. ..
- New Opioids for AlcoholismJohn Cashman; Fiscal Year: 2006..The potential commercial application of the work is that the research could lead to a 'blockbuster' drug product. [unreadable] [unreadable]..
- In Vitro High Throughput Screening Assay for MKP-1(RMI)JOHN LAZO; Fiscal Year: 2005..No potent or selective small molecule inhibitors of this protein phosphatase are known. This proposal will provide sufficient reagents to permit a high throughput screening of 100,000 compounds. ..
- DETERMINANTS OF ESTRAMUSTINE RESISTANCE AND RESPONSEKenneth Tew; Fiscal Year: 2004..abstract_text> ..
- Symptom Assessment After Stem Cell TransplantJohn Graham Pole; Fiscal Year: 2006..abstract_text> ..
- Ras/Raf & PI3K/Akt Induced Breast Cancer Drug ResistanceJAMES MC CUBREY; Fiscal Year: 2007..Throughthese studies,moreinformationwillbe availableto treatbreast andothercancerpatientswithcombinationsof drugs,whichinhibitsignaltransductionand anti-apoptoticpathwaysleadingtodrug resistance. ..
- BIOCHEMICAL REGULATORS OF BLEOMYCIN INDUCED TUMORSJOHN LAZO; Fiscal Year: 2001..The Specific Aims are to: 1) develop cells and mice deficient in BH, 2) develop cells and mice that overexpress BH, 3) isolate and characterize potential proteins that interact with BH and, 4) analyze the regulation of BH expression. ..