Summary: The relative equivalency in the efficacy of different modes of treatment of a disease, most often used to compare the efficacy of different pharmaceuticals to treat a given disease.
Publications238 found, 100 shown here
- Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statementGilda Piaggio
Statistics and Informatics Services Group, Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland
JAMA 295:1152-60. 2006..The intent is to improve reporting of noninferiority and equivalence trials, enabling readers to assess the validity of their results and conclusions...
- Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and meta-analysisAaron S Kesselheim
Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women s Hospital, Harvard Medical School, Boston, MA 02120, USA
JAMA 300:2514-26. 2008..Use of generic drugs, which are bioequivalent to brand-name drugs, can help contain prescription drug spending. However, there is concern among patients and physicians that brand-name drugs may be clinically superior to generic drugs...
- Abacavir-lamivudine-zidovudine vs indinavir-lamivudine-zidovudine in antiretroviral-naive HIV-infected adults: A randomized equivalence trialS Staszewski
Klinikum der Johann Wolfgang Goethe Universitat, Zentrum der Inneren Medizin, Infektionsambulanz, Haus 68, Theodor Stern Kai 7, D 60596 Frankfurt, Germany
JAMA 285:1155-63. 2001..However, the role of abacavir in a triple nucleoside combination regimen has not been evaluated against a standard protease inhibitor-containing regimen for initial antiretroviral treatment...
- The challenge of biosimilarsH Mellstedt
Cancer Centre Karolinska, Department of Oncology, Karolinska University Hospital Solna, Stockholm, Sweden
Ann Oncol 19:411-9. 2008..The purpose of this report was to review issues associated with the introduction of alternative versions of biosimilars used in the oncology setting...
- Biopharmaceutics classification system: the scientific basis for biowaiver extensionsLawrence X Yu
Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Science, Rockville, Maryland 20857, USA
Pharm Res 19:921-5. 2002..3. Use the intrinsic dissolution method for solubility classification. 4. Define an intermediate solubility class for BCS Class II drugs. 5. Include surfactants in in vitro dissolution testing...
- Evaluation of bioequivalence for highly variable drugs with scaled average bioequivalenceLaszlo Tothfalusi
Department of Pharmacodynamics, Semmelweis University, Budapest, Hungary
Clin Pharmacokinet 48:725-43. 2009..Standardized open software could be very useful in this regard. A small program script is presented to calculate SABE confidence limits...
- Bioequivalence approaches for highly variable drugs and drug productsSam H Haidar
Office of Generic Drugs, Food and Drug Administration, 7500 Standish Place, Rockville, Maryland, 20855, USA
Pharm Res 25:237-41. 2008..A partial replicated-treatment design with this new data analysis methodology will thus provide a more efficient design for BE studies with highly variable drugs and drug products...
- Loss of response after switching from brand name to generic formulations: three cases and a discussion of key clinical considerations when switchingHoward C Margolese
Department of Psychiatry, McGill University, Montreal, Quebec, Canada
Int Clin Psychopharmacol 25:180-2. 2010..Generic switching should be decided on a case-by-case basis with disclosure of potential consequences to the patient...
- Pharmacokinetic and pharmacodynamic profile of new biosimilar filgrastim XM02 equivalent to marketed filgrastim Neupogen: single-blind, randomized, crossover trialHeinz Lubenau
BioGeneriX AG, Mannheim, Germany
BioDrugs 23:43-51. 2009..This study was conducted to compare the pharmacokinetic and pharmacodynamic characteristics of the new biosimilar filgrastim XM02 with the marketed filgrastim (Neupogen)...
- Pharmacokinetic comparison of fast-disintegrating and conventional tablet formulations of risperidone in healthy volunteersErno A van Schaick
Johnson and Johnson Pharmaceutical Research and Development, Beerse, Belgium
Clin Ther 25:1687-99. 2003..In recent years, rapidly dissolving oral drug formulations have been developed to overcome problems related to swallowing difficulties...
- Seizure outcomes following the use of generic versus brand-name antiepileptic drugs: a systematic review and meta-analysisAaron S Kesselheim
Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women s Hospital and Harvard Medical School, Boston, Massachusetts 02120, USA
Drugs 70:605-21. 2010..In the absence of better data, physicians may want to consider more intensive monitoring of high-risk patients taking AEDs when any switch occurs...
- The therapeutic equivalence of complex drugsHuub Schellekens
Department of Pharmaceutical Sciences, Utrecht University, P O Box 80 082, 3508 TB Utrecht, The Netherlands
Regul Toxicol Pharmacol 59:176-83. 2011....
- Generic products of antiepileptic drugs: a perspective on bioequivalence and interchangeabilityMeir Bialer
Faculty of Medicine, Institute of Drug Research, School of Pharmacy and David R Bloom Center for Pharmacy, The Hebrew University of Jerusalem, Jerusalem, Israel
Epilepsia 51:941-50. 2010....
- Characterization of the human upper gastrointestinal contents under conditions simulating bioavailability/bioequivalence studiesLida Kalantzi
Laboratory of Biopharmaceutics and Pharmacokinetics, School of Pharmacy, University of Athens, Panepistimiopolis, 157 71, Zografou, Greece
Pharm Res 23:165-76. 2006....
- Comparison of skin stripping, in vitro release, and skin blanching response methods to measure dose response and similarity of triamcinolone acetonide cream strengths from two manufactured sourcesLynn K Pershing
Department of Dermatology, University of Utah School of Medicine, 4B454 SOM, 30 N 1900 E, Salt Lake City, UT 84132, USA
J Pharm Sci 91:1312-23. 2002..Data support the use of dermatopharmacokinetic methods for bioequivalence and bioavailability assessment of topical drug products...
- Bioequivalence evaluation of two strengths of risperidone tablet formulations in healthy volunteersM Canovas
R and D area, Laboratorios Lesvi, S L, Invent Farma Group, Universitat Autonoma de Barcelona, Servei de Farmacologia Clinica, IDIBAPS, Hospital Clinic, Barcelona, Spain
Int J Clin Pharmacol Ther 47:124-31. 2009..A., Barcelona, Spain, reference product manufactured by Janssen-Cilag Ltd., UK)...
- Biosimilars: pharmacovigilance and risk managementLeyre Zuñiga
Faculty of Pharmacy, Pharmaceutical Technology Department, University of the Basque Country, Vitoria Gasteiz, Spain
Pharmacoepidemiol Drug Saf 19:661-9. 2010..Biologicals should always be commercialized with a brand name or the INN plus the manufacturer's name...
- Assessing bioequivalence of generic antiepilepsy drugsGregory L Krauss
Department of Neurology, Johns Hopkins University, Baltimore, MD, USA
Ann Neurol 70:221-8. 2011....
- Truncated area under the urinary excretion rate curve in the evaluation of alendronate bioequivalence after a single dose in healthy volunteersAntonio Portolés
Clinical Pharmacology Studies Unit, Department of Clinical Pharmacology, Hospital Clinico San Carlos, Madrid, Spain
Arzneimittelforschung 59:397-402. 2009..The results of the present study suggest that the test formulation is bioequivalent to the reference formulation. The analyses of truncated AURC to shorter times showed similar values, which were within the range of bioequivalence...
- EMEA guidelines on biosimilars and their clinical implicationsJerome Rossert
Amgen Global Safety, Thousand Oaks, Calif 91320, USA
Kidney Blood Press Res 30:13-7. 2007
- Existing and new criteria for bioequivalence evaluation of new controlled release (CR) products of carbamazepineM Bialer
Department of Pharmaceutics, School of Pharmacy, Faculty of Medicine, The Hebrew University of Jerusalem, Israel
Epilepsy Res 32:371-8. 1998....
- FDA critical path initiatives: opportunities for generic drug developmentRobert A Lionberger
Office of Generic Drugs, Food and Drug Administration, 7519 Standish Place, Rockville, Maryland 20850, USA
AAPS J 10:103-9. 2008....
- An alternative approach for assessment of rate of absorption in bioequivalence studiesM L Chen
Division of Bioequivalence, HFD 655, Office of Generic Drugs MPN II, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20857
Pharm Res 9:1380-5. 1992..The method was shown to be useful in the assessment of rate of absorption in bioequivalence studies...
- Exposure measures applied to the bioequivalence of two sustained release formulations of bupropionK K Midha
PharmaLytics Inc, Drug Metabolism, Drug Disposition Institute, University of Saskatchewan, Canada
Int J Clin Pharmacol Ther 43:244-54. 2005..The ratio C(max)/AUC (sensitive to rate of absorption) was also evaluated...
- Differences in bioavailability between 60 mg of nifedipine osmotic push-pull systems after fasted and fed administrationM Anschütz
SocraTec R and D, 61440 Oberursel, Germany
Int J Clin Pharmacol Ther 48:158-70. 2010....
- Exposure-response analysis reveals that clinically important toxicity difference can exist between bioequivalent carbamazepine tabletsLaszlo Tothfalusi
Department of Pharmacodynamics, Semmelweis University, Budapest, Hungary
Br J Clin Pharmacol 65:110-22. 2008..A secondary goal was to demonstrate quantitatively the relationship between the risk of neurological adverse effects to orally ingested CBZ and the rate of absorption...
- Bioequivalence studies on bisphosphonates: the example of alendronateAudrey Lainesse
SFBC Anapharm, Sainte Foy, Quebec, Canada
Arzneimittelforschung 54:569-72. 2004..96 and 1.11 for Rmax, and thus within the acceptance range for bioequivalence trials. In the light of the present study it can be concluded that alendronate test tablets are bioequivalent to the reference formulation...
- Use of partial AUC to demonstrate bioequivalence of Zolpidem Tartrate Extended Release formulationsRobert A Lionberger
Office of Generic Drugs, Office of Pharmaceutical Science Center for Drug Evaluation and Research, Food and Drug Administration, 7519 Standish Pl, Rockville, Maryland 20855, USA
Pharm Res 29:1110-20. 2012..Modeling and simulation studies were performed to aid in understanding the need for pAUC measures and also the proper pAUC truncation times...
- In vitro and in vivo equivalence studies of alendronate monosodium tabletsEmilio José Antonio Roldán
Scientific Direction, Gador SA, Buenos Aires, Argentina
Arzneimittelforschung 55:93-101. 2005....
- Assuring quality and performance of sustained and controlled release parenterals: workshop reportDiane J Burgess
Department of Pharmaceutics, University of Connecticut, 372 Fairfield Road, Storrs, CT 06269, USA
AAPS PharmSci 4:E7. 2002..Recommendations were made for future workshops, meetings and working groups in this area...
- An alternative single dose parameter to avoid the need for steady-state studies on oral extended-release drug productsPaulo Paixão
iMed UL, Faculdade de Farmacia, Universidade de Lisboa, Lisboa, Portugal
Eur J Pharm Biopharm 80:410-7. 2012..This proposed approach results in the reduction in the number of studies and volunteers enrolled in clinical bioequivalence trials, without compromising the quality assurance of a new extended-release oral formulation...
- How critical is the duration of the sampling scheme for the determination of half-life, characterization of exposure and assessment of bioequivalence?Philippe Colucci
J Pharm Pharm Sci 14:217-26. 2011..Additionally, individual subject's pharmacokinetic parameters should be removed from the pivotal statistical analysis when their associated calculated half-life is longer than half of the total sampling interval...
- Evaluation of bioequivalence of highly variable drugs using clinical trial simulations. II: Comparison of single and multiple-dose trials using AUC and CmaxA A el-Tahtawy
Food and Drug Administration, Center for Drug Evaluation and Research, Rockville, Maryland 20857, USA
Pharm Res 15:98-104. 1998..The main methodology was Monte Carlo simulation, and we also used deterministic simulation, and examination of clinical trials. The results are compared with those previously observed for Cmax (maximum concentration.)..
- Pharmacokinetics, efficacy and toxicity of different pegylated liposomal doxorubicin formulations in preclinical models: is a conventional bioequivalence approach sufficient to ensure therapeutic equivalence of pegylated liposomal doxorubicin products?Rao N V S Mamidi
Preclinical Development, Johnson and Johnson Pharmaceutical Research Development LLC, 1000 US 202S, Raritan, NJ, USA
Cancer Chemother Pharmacol 66:1173-84. 2010....
- Using partial area for evaluation of bioavailability and bioequivalenceMei Ling Chen
Office of Pharmaceutical Science Center for Drug Evaluation and Research Food and Drug Administration, 10903 New Hampshire Avenue, Building 51, Rm 4108, Silver Spring, Maryland 20993 0002, USA
Pharm Res 28:1939-47. 2011..The partial area metric is useful in PK/PD characterization as well as in the evaluation of bioavailability, bioequivalence and/or comparability...
- Do regulatory bioequivalence requirements adequately reflect the therapeutic equivalence of modified-release drug products?Laszlo Endrenyi
Department of Pharmacology and Toxicology, University of Toronto, Toronto, ON, Canada
J Pharm Pharm Sci 13:107-13. 2010..To demonstrate that current regulatory requirements for bioequivalence (BE) do not always reflect therapeutic equivalence. To investigate the potential usefulness of an additional metric, the partial AUC...
- Investigation on the need of multiple dose bioequivalence studies for prolonged-release generic productsAlfredo García-Arieta
División de Farmacología y Evaluación Clínica, Subdirección de Medicamentos de Uso Humano, Agencia Española de Medicamentos y Productos Sanitarios, C Campezo 1, Edificio 8, Planta 2 Oeste, E 28022 Madrid, Spain
Int J Pharm 423:321-5. 2012....
- Measures of exposure versus measures of rate and extent of absorptionM L Chen
Office of Pharmaceutical Science, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20857, USA
Clin Pharmacokinet 40:565-72. 2001..The 3 systemic exposure measures for bioavailability and bioequivalence studies can provide critical links between product quality and clinical outcome and thereby reduce the current emphasis on rate of absorption...
- Oral vinorelbine pharmacokinetics and absolute bioavailability study in patients with solid tumorsM Marty
, Paris, France
Ann Oncol 12:1643-9. 2001..Reliable, corresponding doses between oral and i.v. vinorelbine were established, which will result in bioequivalent AUC...
- An evaluation of consumers' knowledge, perceptions and attitudes regarding generic medicines in AucklandZaheer Ud Din Babar
School of Pharmacy, Faculty of Medical and Health Sciences, University of Auckland, Private Mail Bag 92019, Auckland, New Zealand
Pharm World Sci 32:440-8. 2010..The aim of this project was to evaluate the perceptions, knowledge and attitudes regarding generic medicines...
- Current approaches to the use of generic antiepileptic drugsG Kramer
Swiss Epilepsy Center, Bleulerstrasse 60, Ch 8008 Zurich, Switzerland
Epilepsy Behav 11:46-52. 2007..Both physicians and patients have a right to be informed and approve before pharmacists make a generic substitution or switch between generics...
- Basic facts about biosimilarsMichał Nowicki
Department of Nephrology, Hypertension and Kidney Transplantation, Medical University of Łódź, Łódź, Poland
Kidney Blood Press Res 30:267-72. 2007..Other specific problems which will also be addressed in this review are safety of biosimilars, pharmacovigilance, automatic substitution, naming and labeling/prescription rules...
- 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....
- Are the current bioequivalence standards sufficient for the acceptance of narrow therapeutic index drugs? Utilization of a computer simulated warfarin bioequivalence modelS E Walker
Department of Pharmacy, Sunnybrook Health Sciences Center, Toronto, Canada
J Pharm Pharm Sci 2:15-22. 1999..The bioequivalence testing was performed initially as G(1 )vs. R, then G(2) vs. R, and finally G(2) vs. G(1). The tests were performed according to current criteria for therapeutic index drugs...
- How similar do 'biosimilars' need to be?Huub Schellekens
Utrecht University, Central Laboratory Animal Institute and Department of Innovation Studies, Bolognalaan 50, Utrecht 3584 CJ, Netherlands
Nat Biotechnol 22:1357-9. 2004
- Biosimilarity of HX575 (human recombinant epoetin alfa) and epoetin beta after multiple subcutaneous administrationF Sorgel
IBMP Institute for Biomedical and Pharmaceutical Research, Nürnberg Heroldsberg, Germany
Int J Clin Pharmacol Ther 47:391-401. 2009..Welwyn Garden City, UK)...
- Impact of a generic substitution reform on patients' and society's expenditure for pharmaceuticalsKarolina Andersson
Social Medicine, Department of Public Health and Community Medicine, Sahlgrenska Academy at Goteborg University, P O Box 453, SE 405 30 Goteborg, Sweden
Health Policy 81:376-84. 2007..This suggests that generic substitution has contributed to a reduction in the growth of pharmaceutical expenditure...
- Quality of reporting of noninferiority and equivalence randomized trialsAnne Le Henanff
Institut National de la Santé et de la Recherche Médicale INSERM U738, Paris, France
JAMA 295:1147-51. 2006..These study objectives imply particular planning and analysis...
- Biosimilar epoetins and other "follow-on" biologics: update on the European experiencesWolfgang Jelkmann
Institute of Physiology, University of Luebeck, Ratzeburger Allee 160, Luebeck, Germany
Am J Hematol 85:771-80. 2010..Only on proof of quality, efficacy and safety, biosimilars are a viable option because of their lower costs...
- Therapeutic equivalency of low-molecular-weight heparinsGary M McCart
Department of Clinical Pharmacy, School of Pharmacy, University of California, San Francisco 94143 0622, USA
Ann Pharmacother 36:1042-57. 2002..To review the recent literature on the approved uses of enoxaparin, dalteparin, ardeparin, and tinzaparin and the evidence for therapeutic equivalence...
- Solid state NMR and bioequivalence comparison of the pharmacokinetic parameters of two formulations of clindamycinZ A Al-Talla
Analytical Core Lab, King Abdullah University of Science and Technology, KAUST, Thuwal, Kingdom of Saudi Arabia
Int J Clin Pharmacol Ther 49:469-76. 2011....
- Active-control equivalence trials and antihypertensive agentsF A McAlister
Division of General Internal Medicine, University of Alberta, Alberta, Canada
Am J Med 111:553-8. 2001..The methodological criteria outlined in this article for judging the validity of active-control equivalence trials are not specific to antihypertensive trials and may be applied to trials that test a wide variety of interventions...
- 6th Annual European Antibody Congress 2010: November 29-December 1, 2010, Geneva, SwitzerlandAlain Beck
Physio Chemistry Department, Centre d Immunologie Pierre Fabre, Saint Julien en Genevois, France
MAbs 3:111-32. 2011....
- Are needle-free injections a useful alternative for growth hormone therapy in children? Safety and pharmacokinetics of growth hormone delivered by a new needle-free injection device compared to a fine gauge needleH G Dorr
Department of Paediatric Endocrinology, University Erlangen Nurnberg, Erlangen, Germany
J Pediatr Endocrinol Metab 16:383-92. 2003....
- Neoimmun versus Neoral: a bioequivalence study in healthy volunteers and influence of a fat-rich meal on the bioavailability of NeoimmunF Kees
Department of Pharmacology and Toxicology, University of Regensburg, Universitatsstrasse 31, 93053 Regensburg, Germany
Naunyn Schmiedebergs Arch Pharmacol 375:393-9. 2007..In conclusion, our data show that Neoimmun exhibits a lower bioavailability than the microemulsion Neoral and that food has a significant but variable and sex-dependent impact on the bioavailability of Neoimmun capsules...
- Bioequivalence of HX575 (recombinant human epoetin alfa) and a comparator epoetin alfa after multiple intravenous administrations: an open-label randomised controlled trialFritz Sorgel
IBMP Institute for Biomedical and Pharmaceutical Research, Nurnberg, Germany
BMC Clin Pharmacol 9:10. 2009....
- Application of microbiological assay to determine pharmaceutical equivalence of generic intravenous antibioticsAndres F Zuluaga
Grupo Investigador de Problemas en Enfermedades Infecciosas, University of Antioquia, Medellin, Colombia
BMC Clin Pharmacol 9:1. 2009....
- Challenges and opportunities in establishing scientific and regulatory standards for assuring therapeutic equivalence of modified-release products: workshop summary reportMei Ling Chen
U S Food and Drug Administration, USA
Eur J Pharm Sci 40:148-53. 2010....
- Assessment of cutaneous drug delivery using microdialysisMads Kreilgaard
Department of Neurochemistry and Discovery ADME, H Lundbeck A S, Ottiliavej 9, DK 2500, Valby, Denmark
Adv Drug Deliv Rev 54:S99-121. 2002..Furthermore, it has been indicated that cutaneous microdialysis in rats may be useful for prediction of dermal pharmacokinetic properties of novel drugs/topical formulations in man...
- Transgenic avian-derived recombinant human interferon-alpha2b (AVI-005) in healthy subjects: an open-label, single-dose, controlled studyT B Patel
Department of Pharmacology and Experimental Therapeutics, Thomas Jefferson University, Philadelphia, PA 19107, USA
Int J Clin Pharmacol Ther 45:161-8. 2007..This study characterized the safety and pharmacological properties of AVI-005, a novel glycosylated recombinant human interferon-alpha2b produced from the egg whites of chickens transfected with human cDNA...
- Generic substitution in the treatment of epilepsy: case evidence of breakthrough seizuresM J Berg
Strong Epilepsy Center, University of Rochester Medical Center, Rochester, NY 14642 8673, USA
Neurology 71:525-30. 2008..There are concerns that generic and brand antiepileptic drugs (AEDs) may not be therapeutically equivalent. This study investigated how generic AED substitution may have negative consequences...
- Are there potential problems with generic substitution of antiepileptic drugs? A review of issuesP Crawford
York Hospital, Wigginton Road, York YO31 8HE, UK
Seizure 15:165-76. 2006....
- Choice of delta: requirements and reality--results of a systematic reviewS Lange
Institute for Quality and Efficiency in Health Care, Cologne, Germany
Biom J 47:12-27; discussion 99-107. 2005..Overall, it seems that a more global definition of 'irrelevance' might be warranted...
- Generic substitution of antihypertensive drugs: does it affect adherence?Boris L G Van Wijk
Department of Pharmacoepidemiology and Pharmacotherapy, Faculty of Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands
Ann Pharmacother 40:15-20. 2006..However, pharmacists and physicians often find that patients and brand-name manufacturers have doubt about the equivalence of the substituted drug. This may be reflected by decreased adherence to therapy...
- What do primary care patients think about generic drugs?W Himmel
Department of General Practice, University of Gottingen, Germany
Int J Clin Pharmacol Ther 43:472-9. 2005....
- Bioequivalence of topical formulations in humans: evaluation by dermal microdialysis sampling and the dermatopharmacokinetic methodEva Benfeldt
Department of Dermatology, University of Copenhagen, Gentofte Hospital, Hellerup, Denmark
J Invest Dermatol 127:170-8. 2007..Thus, intersubject variability accounted for 61% of the variance. DMD sampling proved effective and variability analyses demonstrated the feasibility of BE studies in as little as 18 subjects...
- Generic substitution in the treatment of epilepsy: patient and physician perceptionsMichel J Berg
Department of Neurology, University of Rochester Medical Center and Strong Epilepsy Center, Rochester, NY, USA
Epilepsy Behav 13:693-9. 2008..Additional investigation on bioequivalence may help address ongoing concerns and inform policy-making decisions...
- Pharmacokinetic comparison of generic and trade formulations of lamivudine, stavudine and nevirapine in HIV-infected Malawian adultsMina C Hosseinipour
University of North Carolina Project, Lilongwe Malawi
AIDS 21:59-64. 2007..The Malawian antiretroviral program uses generic Triomune (stavudine, lamivudine, and nevirapine)...
- A new approach for outliers in a bioavailability/bioequivalence studyJason J Z Liao
Merck Research Laboratories, West Point, PA 19486, USA
J Biopharm Stat 17:393-405. 2007..A real data set is used to demonstrate the proposed approach...
- Position statement on the coverage of anticonvulsant drugs for the treatment of epilepsyK Liow
Via Christi Comprehensive Epilepsy Center, University of Kansas School of Medicine Wichita, Wichita, KS 67214 3800, USA
Neurology 68:1249-50. 2007
- What's the problem with generic antiepileptic drugs?: a call to actionMichel J Berg
Neurology 68:1245-6. 2007
- Generic products of antiepileptic drugs (AEDs): is it an issue?Meir Bialer
Department of Pharmaceutics, School of Pharmacy and David R Bloom Center for Pharmacy, Faculty of Medicine, The Hebrew University of Jerusalem, Jerusalem, Israel
Epilepsia 48:1825-32. 2007....
- Experience with generic drugs in epilepsy patients: an electronic survey of members of the German, Austrian and Swiss branches of the ILAEGunter Kramer
Epilepsia 48:609-11. 2007
- Compulsory generic switching of antiepileptic drugs: high switchback rates to branded compounds compared with other drug classesFrederick Andermann
Montreal Neurological Institute and Hospital, McGill University, Montreal, Quebec, Canada
Epilepsia 48:464-9. 2007....
- Recommendations of the Italian League against Epilepsy working group on generic products of antiepileptic drugsEmilio Perucca
Clinical Pharmacology Unit and Institute of Neurology IRCCS C Mondino Foundation, University of Pavia, Pavia, Italy
Epilepsia 47:16-20. 2006....
- Pharmacokinetics of recombinant human growth hormone administered by cool.click 2, a new needle-free device, compared with subcutaneous administration using a conventional syringe and needleChris Brearley
Clinical Research, Serono International SA, 1211 Geneva, Swizerland
BMC Clin Pharmacol 7:10. 2007..The objective of this study was to assess the relative bioavailability of r-hGH (Saizen, Merck Serono) administered by a new needle-free device, cool.click 2, and a standard needle and syringe...
- Pharmacokinetic simulation of biowaiver criteria: the effects of gastric emptying, dissolution, absorption and elimination ratesH Kortejärvi
Research and Development, Orion Pharma, P O Box 65, 02101 Espoo, Finland
Eur J Pharm Sci 30:155-66. 2007..Pharmacokinetic simulation model was valuable tool to evaluate biowaiver criteria and to study the effects of drug and physiology gastrointestinal related factors on C(max) and AUC...
- Are all aciclovir cream formulations bioequivalent?L Trottet
GlaxoSmithKline, Weybridge, Surrey, UK
Int J Pharm 304:63-71. 2005..Given the magnitude of the differences seen, there is concern over therapeutic inequivalence of generic ACV creams to the innovator cream...
- Biowaiver extension potential to BCS Class III high solubility-low permeability drugs: bridging evidence for metformin immediate-release tabletChing Ling Cheng
Department of Pharmacy, Chia Nan University of Pharmacy and Science, Tainan, Taiwan
Eur J Pharm Sci 22:297-304. 2004..This study serves as an example for supporting biowaiver for BCS Class III drugs...
- Generic warfarin: implications for clinical practice and perceptions of anticoagulation providersRachel A Bongiorno
University of Maryland School of Pharmacy, Baltimore, Maryland, USA
Semin Thromb Hemost 30:619-26. 2004..The approval of generic formulations of warfarin sodium has generated much debate over the therapeutic equivalency and the appropriateness of therapeutic substitution for the innovator product...
- Understanding the scientific issues embedded in the generic drug approval processL S Welage
Department of Clinical Sciences, College of Pharmacy, University of Michigan Health System, Ann Arbor 48109 1065, USA
J Am Pharm Assoc (Wash) 41:856-67. 2001..To review the major scientific issues embedded in the generic drug approval process...
- Assessment of dermatopharmacokinetic approach in the bioequivalence determination of topical tretinoin gel productsLynn K Pershing
Department of Dermatology, University of Utah, Salt Lake City, 84132, USA
J Am Acad Dermatol 48:740-51. 2003..A new dermatopharmacokinetic (DPK) approach has been proposed for bioequivalence determination of topical drug products by comparing the drug content kinetics in stratum corneum...
- The bioequivalence and therapeutic efficacy of generic versus brand-name psychoactive drugsGiuseppe Borgheini
Neurological and Psychiatric Department, University of Padua, and Casa di Cura Parco dei Tigli, Padua, Italy
Clin Ther 25:1578-92. 2003..However, bioequivalence and therapeutic effectiveness are not necessarily the same...
- A simple formula for sample size calculation in equivalence studiesPaul Zhang
Pfizer Consumer Healthcare, Morris Plains, New Jersey 07950, USA
J Biopharm Stat 13:529-38. 2003..In this paper, we propose a simple formula for sample size calculation based on central t-distribution. The proposed formula has better properties than those currently available and it can be easily applied in all equivalence studies...
- Biowaiver monographs for immediate release solid oral dosage forms based on biopharmaceutics classification system (BCS) literature data: verapamil hydrochloride, propranolol hydrochloride, and atenololH Vogelpoel
RIVM National Institute for Public Health and the Environment, Center for Quality of Chemical Pharmaceutical Products, P O Box 1, 3720 BA Bilthoven, The Netherlands
J Pharm Sci 93:1945-56. 2004..The development of a database with BCS-related data is announced by the International Pharmaceutical Federation (FIP)...
- Therapeutic equivalency of generic antiepileptic drugs: results of a surveyAndrew N Wilner
Suite 317, Americas Building, Newport, RI 02840, USA
Epilepsy Behav 5:995-8. 2004..Fifty-two (18.4%) neurologists agreed that the Food and Drug Administration standards for AED bioavailability are sufficiently narrow; 231 (81.6%) did not...
- Disintegration/dissolution profiles of copies of Fosamax (alendronate)S Epstein
Mount Sinai School of Medicine, New York, NY, USA
Curr Med Res Opin 19:781-9. 2003..We performed a pilot study to compare the disintegration/dissolution profiles of FOSAMAX (alendronate) 70 mg tablets with those of copies of FOSAMAX that were manufactured outside the United States...
- Bioequivalence and other unresolved issues in generic drug substitutionPeter Meredith
University Department of Medicine and Therapeutics, The Western Infirmary, Glasgow, Scotland, United Kingdom
Clin Ther 25:2875-90. 2003..Under these circumstances, measures of individual and population bioequivalence are proposed to be more accurate than measures of average bioequivalence...
- A combined-formulation tablet of lamivudine/nevirapine/stavudine: bioequivalence compared with concurrent administration of lamivudine, nevirapine, and stavudine in healthy Indian subjectsVishal S Narang
Department of Clinical and Bioequivalence Research, Cipla Ltd, Mumbai Central 400008, Mumbai, India
J Clin Pharmacol 45:265-74. 2005..Both treatments exhibited similar tolerability under fasting conditions...
- Progress in methodologies for evaluating bioequivalence of topical formulationsV P Shah
Office of Pharmaceutical Science, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland, USA
Am J Clin Dermatol 2:275-80. 2001..However, confidence in this methodology needs to be established, particularly regarding its relevance to clinical drug efficacy...
- Glycosylated vs non-glycosylated granulocyte colony-stimulating factor (G-CSF)--results of a prospective randomised monocentre studyH Bonig
Department of Paediatric Haematology and Oncology, Center of Child Health, Heinrich Heine University Medical Center, Dusseldorf, Germany
Bone Marrow Transplant 28:259-64. 2001..In summary, at least at 250 microg/m(2), in terms of their clinical effect on neutropenia, the two G-CSF preparations appear to have identical activity...
- Treatment failure after substitution of generic pancrelipase capsules. Correlation with in vitro lipase activityL Hendeles
College of Pharmacy, University of Florida, Gainesville 32610 0486
JAMA 263:2459-61. 1990..We conclude that the Food and Drug Administration should institute regulations over this group of products...
- A physician survey on generic drugs and substitution of critical dose medicationsB F Banahan
Research Institute of Pharmaceutical Sciences, University of Mississippi, USA
Arch Intern Med 157:2080-8. 1997....
- Analysis of chromameter results obtained from corticosteroid-induced skin blanching. I: Manipulation of dataE W Smith
School of Pharmaceutical Sciences, Rhodes University, Grahamstown, South Africa
Pharm Res 15:280-5. 1998..The purpose of this study was to manipulate the instrumental data from a typical blanching study in a number of ways to investigate the appropriateness of these procedures for comparison with the subjective visually-assessed results...
- The biopharmaceutics classification system (BCS): class III drugs - better candidates for BA/BE waiver?H H Blume
SocraTec R and D, Feldbergstrasse 59, 61440, Oberursel, Germany
Eur J Pharm Sci 9:117-21. 1999..This type of drug substance may be an even better candidate for a waiver as, in this case, bioavailability will not so much depend on the formulation characteristics, as on drug substance properties (e.g. permeability)...
- Issues in the use of generic antiarrhythmic drugsJ A Reiffel
Cardiology Division, Department of Medicine, Columbia University, College of Physician and Surgeons and The Arrhythmia Service, Columbia-Presbyterian Medical Center Campus, The New York Presbyterian Hospital, New York, New York, USA
Curr Opin Cardiol 16:23-9. 2001..Additionally, guidelines for allowance or avoidance of antiarrhythmic drug formulation substitution are suggested...
- Generic substitution: issues for problematic drugsJ D Henderson
Department of Physician Assistant Studies, College of Allied Health Professions, University of South Alabama College of Medicine, Mobile, USA
South Med J 94:16-21. 2001..Yet, misinformation and myths persist regarding the adequacy and proven reliability of the FDA's determination of bioequivalence for these products...
- [The clinical and economic impact of generic drugs in the treatment of epilepsy]A Argumosa
Department of Neuropediatrics, Hospital Universitario Marques de Valdecilla, University of Cantrabria, Avenida Valdecilla s n, E 39008 Santander, Cantabria, Spain
Rev Neurol 41:45-9. 2005..The aim of this study was to determine whether the introduction of generic formulations of antiepileptic drugs (AED) would lead to an economic saving for the public health service...
- Patient and physician reactions to generic antiepileptic substitution in the treatment of epilepsyLisa S Haskins
Harris Interactive Health Care Division, Rochester, NY, USA
Epilepsy Behav 7:98-105. 2005..The clinical and economic consequences of generic antiepileptic drug (AED) substitution are not yet fully understood. This article provides a broad perspective of generic AED substitution in five countries...
- Abacavir/lamivudine/zidovudine as a combined formulation tablet: bioequivalence compared with each component administered concurrently and the effect of food on absorptionG J Yuen
Glaxo Wellcome, Inc, Research Triangle Park, North Carolina 27709, USA
J Clin Pharmacol 41:277-88. 2001..All formulations were well tolerated underfasted and fed conditions...
- Influence of a microemulsion vehicle on cutaneous bioequivalence of a lipophilic model drug assessed by microdialysis and pharmacodynamicsM Kreilgaard
The Royal Danish School of Pharmacy, Department of Pharmaceutics, Copenhagen
Pharm Res 18:593-9. 2001....
- Substrate requirements of the bile acid transporterJAMES POLLI; Fiscal Year: 2009..This systematic and progressive approach will serve as a prototypical method to elucidate the substrate requirements of other solute carrier (SLC) proteins. ..
- Pharmacotherapy for Minor DepressionRobert Howland; Fiscal Year: 2004..The results of this study will have profound public health implications by improving our understanding of the efficacy of SJW and standard antidepressants for the treatment of MinorD. ..
- Digoxin Chiral Isolates as Improved PharmaceuticalsJohn Somberg; Fiscal Year: 2005..The advantage would be a treatment for AF that did not cause cardiac augmentation and vasoconstriction or a treatment for CHF that does not cause heart rate slowing or conduction disturbances. ..
- Transporter-Enzyme Interplay Evaluation via Microfluidiic HTS Cell Culture DeviceLeslie Benet; Fiscal Year: 2008..unreadable] [unreadable] [unreadable]..
- ACYLCOA FORMATION--COVALENT BINDING, PHARMACOKINETICSLeslie Benet; Fiscal Year: 2002....
- Antiretroviral Pharmacology/Lactating Mother/InfantsMark Mirochnick; Fiscal Year: 2006..This information is needed for the safe and effective use of antiretrovirals in nursing women, and will pioneer a novel approach to the study of breast milk drug transfer. ..
- Delivery of Agents by Modulating Junctions with ZotNatalie Eddington; Fiscal Year: 2006..The potential impact of the Zot technology is significant and comprehensive, since it may be applied to delivering a diversified range of macromolecules to their targets via oral, BBB or nasal delivery. ..
- Glioma Immunotherapy Usingengineered T-CellsMichael Jensen; Fiscal Year: 2006..These data will form the basis for designing Phase I/II trials using enhanced T-cell dosing schedules, imaging techniques, and surrogate marker endpoints. ..
- WT1 Expression in Patients with MDS Treated with ATG an*H Deeg; Fiscal Year: 2007..unreadable] [unreadable]..
- Novel Ternary Ligand 99m Tc-Nitrido Complexes as Heart Imaging AgentsShuang Liu; Fiscal Year: 2007..unreadable] [unreadable] [unreadable]..
- Chemopreventive Actions of Equol EnantiomersKenneth Setchell; Fiscal Year: 2007..These studies are relevant to humans given the ammended health claim for soy and cancer risk-reduction currently being reviewed by the FDA. ..
- Clinical Activity of 17-AAG in LymphomaAnas Younes; Fiscal Year: 2007..In Aim 3 we will correlate the biologic effects of 17-AAG and clinical response in patients with relapsed MCL, ALCL, and HL. [unreadable] [unreadable] [unreadable]..
- Safety Pharmacokinetics & Efficacy of Artemether & Lumefantrine in Pregnant WomenMark Mirochnick; Fiscal Year: 2008..The data from this planned study will provide the information needed to ensure that pregnant women receive the appropriate doses of these anti-malaria drugs. [unreadable] [unreadable] [unreadable]..
- Robust Hierarchical Finite Mixture Modeling of Collagen Fibril DiametersInna Chervoneva; Fiscal Year: 2008..This project focuses on developing novel statistical methods for analyses of such decompositions. [unreadable] [unreadable] [unreadable]..
- Cell Death and Clonal Survival in Myelodysplastic Syndr*H Deeg; Fiscal Year: 2008..To achieve these objectives, we must better understand the underlying mechanisms of MDS and thereby identify ways by which the disease process can be arrested, progression prevented, and the disease hopefully be cured. ..
- Validation of rat models for resistant epilepsy therapyWolfgang Loscher; Fiscal Year: 2005..Our goal is to establish standard assays that can be employed by researchers to continue the search for treatments of drug resistant epilepsy. ..
- P-Glycoprotein and Disposition of PsychostimulantsJOHN MARKOWITZ; Fiscal Year: 2005....
- Enhancing the Prospective Prediction of PsychosisScott Woods; Fiscal Year: 2007..Each site has provefi its ability to recruit prodromal patients in a previous collaboration. ..
- TREATMENT OF PANIC DISORDER--LONG TERM STRATEGIESScott Woods; Fiscal Year: 2003..Thus, we are proposing to add these aims. ..
- Ginkgo biloba for ECT-induced Memory DeficitsJOHN MARKOWITZ; Fiscal Year: 2003..will utilize larger groups and additional cognitive tests will be incorporated to provide more definitive conclusions regarding efficacy, optimal dose and duration, persistence of effects, and safety and tolerability ..
- NOVEL THERAPEUTIC STRATEGIES IN MYELODYSPLASTIC SYNDROMEH Deeg; Fiscal Year: 2003..Optimization of therapy, in turn, should reduce morbidity and mortality associated with MDS and improve the quality of life of patients with MDS. ..
- Cellular Immunotherapy for Neuroblastoma With CTL clonesMichael Jensen; Fiscal Year: 2002..4.) To assess in this patient population the development of antibody and cellular immune responses against the scFvFc:zeta and HyTK chimeric proteins. ..
- SLEEP, FATIGUE, AND DEXAMETHOSONE IN CHILDHOOD CANCERPamela Hinds; Fiscal Year: 2003..Our study findings will explicate the relationship between sleep efficiency and fatigue, and between sleep, fatigue, and systemic exposure to dexamethasone. ..
- Modulation of BBB to Enhance CNS ChemotherapyNatalie Eddington; Fiscal Year: 2003..Experience in these areas will enhance her research skills and capabilities and will allow her to contribute to research in the area of anticancer drug delivery and pharmacokinetics...
- TARDIVE DYSKINESIA INCIDENCE AND ATYPICAL ANTIPSYCHOTICScott Woods; Fiscal Year: 2004..The existence of a previous sample at the same site provides a useful additional comparison group. Methods including sample ascertainment and TD assessment are closely modeled after the original work. ..
- Screening Herbs for Drug InteractionsJOHN MARKOWITZ; Fiscal Year: 2002..Further, the proposed studies will complement existing and future NCCAM studies of agents such as St. John's wort and Gingko biloba. ..
- Therapeutic Interventions for HIV-1 CNS Sequestration.Natalie Eddington; Fiscal Year: 2005..Obtaining therapeutic CNS levels of anti-retroviral agents is essential to minimizing HIV-1 in the CNS. As such, this proposal offers a viable approach to address this complication of HIV/AIDS. ..
- Ab Alphavirus Replicon Vaccine against CytomegalovirusRobert Esch; Fiscal Year: 2005..PROPOSED COMMERCIAL APPLICATIONS: An effective CMV vaccine will prevent mental retardation and hearing loss associated with congenital CMV disease, thereby addressing an important unmet public health problem. ..
- A Novel Therapy for Depression with Co-Occurring PanicEllen Frank; Fiscal Year: 2003....
- Depression: The Search for Treatment-Relevant PhenotypesEllen Frank; Fiscal Year: 2009..Signal detection analysis will be used to determine which combination of spectrum assessment scores and other clinical variables describe the profile of patients likely to stabilize or relapse with each of the treatments. ..
- PATIENT AND PUBLIC EDUCATION IN CANCER PAIN MANAGEMENTBetty Ferrell; Fiscal Year: 2002..This course will impact 120 healthcare settings to improve pain management and quality of life in cancer patients and to establish model pain education programs for national dissemination. ..
- Novel Cationic 99mTc Complexes for Heart ImagingShuang Liu; Fiscal Year: 2006..Successful development of new 99mTc perfusion imaging agents will have a profound impact on diagnostic evaluation, risk stratification, and therapeutic decision-making in patients with CAD. ..
- Soy Isoflavone Metabolite Equol--Formation and FateKenneth Setchell; Fiscal Year: 2008..abstract_text> ..
- Epileptogenicity in the Developing BrainRaman Sankar; Fiscal Year: 2007..Our findings will provide the basis for future neuroprotective interventions targeting the developing brain at different stages of status epilepticus in order to interrupt the course of the epileptogenic process. ..
- OPTIMIZATION OF HUMAN FETAL PANCREAS FOR TRANSPLANTATIONHans Sollinger; Fiscal Year: 2001..The results of these studies will provide a sufficient source of HFP tissue for clinical transplantation which responds to glucose challenge and requires minimal immunosuppressive therapy. ..
- Reducing Barriers to Pain and Fatigue ManagementBetty Ferrell; Fiscal Year: 2009....
- End of Life Nursing Education through Graduate ProgramsBetty Ferrell; Fiscal Year: 2006..This proposal includes extensive evaluation planned to monitor individual and institutional dissemination. ..
- DAART+ AS A STRUCTURAL HIV INTERVENTION IN METHADONE MAINTENANCEJames Sorensen; Fiscal Year: 2007..unreadable] [unreadable] [unreadable] [unreadable]..
- Therapeutic Community and Opioid Replacement TherapyJames Sorensen; Fiscal Year: 2005..The research is an important part of the effort to further link the TC and opioid replacement treatment modalities. ..
- Oncology Nursing Education in End of Life CareBetty Ferrell; Fiscal Year: 2007..This proposal includes extensive evaluation planned to monitor individual and institutional dissemination. [unreadable] [unreadable] [unreadable]..
- Structural Domains Essential for Serotonin Receptor PharmacologyBryan Roth; Fiscal Year: 2006..Novel techniques of protein biochemistry (hydroxyl-mediated 1H/2H exchange), cell biology (yeast 2-hybrid screening) and spectroscopy (FRET/BRET) will be used to arrive at testable models for 5-HT2A-Gq interactions. ..