Genomes and Genes
Summary: The presence of organisms, or any foreign material that makes a drug preparation impure.
Publications244 found, 100 shown here
- Isolation and characterization of contaminants in recalled unfractionated heparin and low-molecular-weight heparinChristian Viskov
Sanofi Aventis, 13 quai Jules Guesde, Vitry sur Seine, France
Clin Appl Thromb Hemost 15:395-401. 2009..The process involved in the production of enoxaparin does not significantly degrade OSCS...
- DNA barcode identification of black cohosh herbal dietary supplementsDavid A Baker
Stony Brook University Medical Center, Stony Brook, NY 11794, USA
J AOAC Int 95:1023-34. 2012..cimicifuga, A. dahurica, and A. simplex). Manufacturers should routinely test plant material using a reliable assay to ensure accurate labeling...
- Quality of herbal medicines: challenges and solutionsJunhua Zhang
State Key laboratory of Modern Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China
Complement Ther Med 20:100-6. 2012..Through the use of modern analytical methods and pharmaceutical techniques, previously unsolved internal issues have become solvable. Standard herbal products can be manufactured from the standard herbal extracts...
- An outbreak of streptococcus endophthalmitis after intravitreal injection of bevacizumabRoger A Goldberg
Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida 33136, USA
Am J Ophthalmol 153:204-208.e1. 2012..To report a series of patients with Streptococcus endophthalmitis after injection with intravitreal bevacizumab prepared by the same compounding pharmacy...
- Purity control of some Chinese crude herbal drugs marketed in ItalyG Mazzanti
Department of Human Physiology and Pharmacology, University La Sapienza, Piazzale Aldo Moro 5, 00185 Rome, Italy
Food Chem Toxicol 46:3043-7. 2008..Our results, even if obtained from a small number of herbal drugs, show some purity issues and underline the importance of the quality control, particularly for this kind of products whose therapeutic value is not always demonstrated...
- A case of septicaemic anthrax in an intravenous drug userArfon G M T Powell
Department of Surgical Gastroenterology, Gartnavel General Hospital, Glasgow, UK
BMC Infect Dis 11:21. 2011..In 2008, there were 574 drug related deaths in Scotland, of which 336 were associated with heroin and or morphine. We report a rare case of septicaemic anthrax caused by injecting heroin contaminated with anthrax in Scotland...
- Adverse effects of herbal drugs in dermatologyE Ernst
Department of Complementary Medicine, School of Postgraduate Medicine and Health Sciences, University of Exeter, 25 Victoria Park Road, Exeter EX2 4NT, UK
Br J Dermatol 143:923-9. 2000..It is concluded that adverse effects of herbal medicines are an important albeit neglected subject in dermatology, which deserves further systematic investigation...
- Heavy metal and pesticide content in commonly prescribed individual raw Chinese Herbal MedicinesEric S J Harris
Department of Biological Chemistry and Molecular Pharmacology, Harvard Medical School, 240 Longwood Avenue, Boston, MA 02115, USA
Sci Total Environ 409:4297-305. 2011....
- Oversulfated chondroitin sulfate is a contaminant in heparin associated with adverse clinical eventsMarco Guerrini
Istituto di Ricerche Chimiche e Biochimiche G Ronzoni, Città Studi, via Giuseppe, Colombo 81, 20133 Milan, Italy
Nat Biotechnol 26:669-75. 2008..Our analysis suggests effective screening methods that can be used to determine whether or not heparin lots contain the contaminant reported here...
- Lessons learned from the contamination of heparinHaiying Liu
Department of Chemistry, Rensselaer Polytechnic Institute, Troy, New York 12180, USA
Nat Prod Rep 26:313-21. 2009..Effective assays, which can detect both known and unknown contaminants, are required to monitor the quality of heparin. Safer and better-regulated processes are needed for heparin production...
- Effect of Ca2+ on the 1H NMR chemical shift of the methyl signal of oversulphated chondroitin sulphate, a contaminant in heparinIan McEwen
Medical Products Agency, Box 26, SE 75103 Uppsala, Sweden
J Pharm Biomed Anal 49:816-9. 2009..This Ca2+ effect can be used for OSCS identification as well as to facilitate quantification...
- Analysis of crude heparin by (1)H NMR, capillary electrophoresis, and strong-anion-exchange-HPLC for contamination by over sulfated chondroitin sulfateDavid A Keire
Food and Drug Administration, Division of Pharmaceutical Analysis, 1114 Market St, Saint Louis, MO 63101, USA
J Pharm Biomed Anal 51:921-6. 2010..5M NaCl solution. This SAX-HPLC approach gave a weight percent LOD of 0.02% and a LOQ of 0.07% and had better performance characteristics than that of the protocol used for APIs...
- Lethal outbreak of infection with Clostridium novyi type A and other spore-forming organisms in Scottish injecting drug usersChristopher C McGuigan
Greater Glasgow NHS Board, Scotland
J Med Microbiol 51:971-7. 2002..The findings are consistent with an infection resulting from injection into soft tissue of acidified heroin contaminated with spore-forming bacteria. Toxin production led to a severe local reaction and, in many, multi-system failure...
- Some oral poliovirus vaccines were contaminated with infectious SV40 after 1961Rochelle Cutrone
Thoracic Oncology Program, Cardinal Bernardin Cancer Center, Loyola University, Chicago, Illinois, USA
Cancer Res 65:10273-9. 2005..Moreover, our results indicate possible geographic differences in SV40 exposure and offer a possible explanation for the different percentage of SV40-positive tumors detected in some laboratories...
- Contaminated heparin associated with adverse clinical events and activation of the contact systemTakashi Kei Kishimoto
Momenta Pharmaceuticals, the Harvard Massachusetts Institute of Technology Division of Health Sciences and Technology, Koch Institute for Integrative Cancer Research, Cambridge, MA 02139, USA
N Engl J Med 358:2457-67. 2008....
- Lack of herbal supplement characterization in published randomized controlled trialsPeter M Wolsko
Kaiser Permanente Medical Group, Denver, CO 80020, USA
Am J Med 118:1087-93. 2005..We assessed the extent to which recently published randomized controlled trials of herbal supplements characterized and verified the content of the supplement under study...
- Manslaughter by fake artesunate in Asia--will Africa be next?Paul N Newton
Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford, Churchill Hospital, Oxford, United Kingdom
PLoS Med 3:e197. 2006
- Oversulfated chondroitin sulfate interaction with heparin-binding proteins: new insights into adverse reactions from contaminated heparinsBoyangzi Li
Department of Chemistry and Chemical Biology, Center for Biotechnology and Interdisciplinary Studies, Rensselaer Polytechnic Institute, Troy, NY 12180, USA
Biochem Pharmacol 78:292-300. 2009..In contrast to heparin, oversulfated chondroitin sulfate tightly binds factor XIIa suggesting a biochemical mechanism for the factor XIIa-based enhancement of vasoactive bradykinin production...
- Inhibition of Taq polymerase as a method for screening heparin for oversulfated contaminantsCecilia Tami
Laboratory of Immunology, Division of Therapeutic Proteins, Office of Biotechnology Products, Center for Drugs Evaluation and Research, Food and Drug Administration, Rockville Pike, Bethesda, MD 20892, USA
Biomaterials 29:4808-14. 2008..This method requires less than 100 miliUnits (mU) of heparin as starting material, therefore avoiding the need to lyophilize and concentrate samples, and has a limit of detection of <1 ng for all oversulfated GAGs tested...
- Epoetin-associated pure red cell aplasia in patients with chronic kidney disease: solving the mysteryKatia Boven
Service d Hematologie Biologique, Hopital Hotel Dieu, 1 Place du Parvis Notre Dame, 75181 Paris cedex 4, France
Nephrol Dial Transplant 20:iii33-40. 2005..In conclusion, these data strongly suggest that leachates were the critical contributory factor in the increased incidence of antibody-mediated PRCA attributed to EPREX/ERYPO...
- Analysis of particulate contaminations of infusion solutions in a pediatric intensive care unitThomas Jack
Department of Pediatric Cardiology and Intensive Care Medicine, Hannover Medical School, Hannover, Germany
Intensive Care Med 36:707-11. 2010....
- DNA barcodes for discriminating the medicinal plant Scutellaria baicalensis (Lamiaceae) and its adulterantsXiaorong Guo
Institute of Ecology and Geobotany, School of Life Sciences, Yunnan University, Kunming 650091, P R China
Biol Pharm Bull 34:1198-203. 2011..The DNA barcoding technique could be applied to the quality control of "Huang Qin"-based medicinal preparations and to the management of medicinal herb trade in the markets...
- Rapid identification of sibutramine in dietary supplements using a stepwise approachD Csupor
Department of Pharmacognosy, University of Szeged, Szeged, Hungary
Pharmazie 68:15-8. 2013..The multistep method proposed by the authors allows the quick identification of sibutramine in counterfeit samples in laboratories with different instrumentation...
- Strategies for the assessment of protein aggregates in pharmaceutical biotech product developmentJohn den Engelsman
Biological and Sterile Product Development, MSD, Oss, The Netherlands
Pharm Res 28:920-33. 2011..Moreover, we elaborate on why these methods should be used during product development and make recommendations to the biotech community with regard to strategies for their application during the development of protein therapeutics...
- Molecular authentication of the ethnomedicinal plant Sabia parviflora and its adulterants by DNA barcoding techniqueXue Yi Sui
Kunming Institute of Botany, Chinese Academy of Sciences, Kunming, P R China
Planta Med 77:492-6. 2011..Our results suggest that the three candidate barcodes can be used for the identification of S. parviflora and to distinguish it from common substitutes or adulterants...
- Particulate matter contamination of intravenous antibiotics aggravates loss of functional capillary density in postischemic striated muscleHans Anton Lehr
Institute of Pathology, University of Mainz, Germany
Am J Respir Crit Care Med 165:514-20. 2002..e., after trauma, major surgery, or sepsis) and thus predispose to complications such as acute respiratory distress syndrome or multiple organ failure...
- Substandard medicines in resource-poor settings: a problem that can no longer be ignoredJ M Caudron
Medecins Sans Frontieres, Geneva, Switzerland, and AEDES Fondation, Brussels, Belgium
Trop Med Int Health 13:1062-72. 2008..Governments in rich countries should not tolerate the export of substandard pharmaceutical products to poor countries, while developing country governments should improve their ability to detect substandard medicines...
- In-line filtration reduces severe complications and length of stay on pediatric intensive care unit: a prospective, randomized, controlled trialThomas Jack
Department of Pediatric Cardiology and Intensive Care Medicine, Hannover Medical School, Carl Neuberg Strasse 1, 30625 Hannover, Germany
Intensive Care Med 38:1008-16. 2012..Particulate contamination due to infusion therapy carries a potential health risk for intensive care patients...
- Protein isolated from biopharmaceutical formulations cannot be used for comparative studies: Follow-up to "a case study using Epoetin Alfa from Epogen and EPREX"G A Heavner
Centocor R and D, 145 King of Prussia Road, Radnor, PA 19087, USA
J Pharm Sci 96:3214-25. 2007....
- Infantile lead poisoning from an Asian tongue powder: a case report & subsequent public health inquiryAlan D Woolf
Department of Medicine, Children s Hospital, Boston, Massachusetts 02115, USA
Clin Toxicol (Phila) 46:841-4. 2008..Lead poisoning from novel environmental sources continues to present a challenge to clinicians who treat infants and children...
- Adulterants in illicit drugs: a review of empirical evidenceClaire Cole
Liverpool John Moores University, Centre for Public Health, Liverpool, United Kingdom
Drug Test Anal 3:89-96. 2011..As part of that strategy, analyses performed for adulterants needs to be encouraged, which are considerably limited in number and scope at the moment...
- Presence of infectious RD-114 virus in a proportion of canine parvovirus isolatesRokusuke Yoshikawa
Laboratory of Signal Transduction, Department of Cell Biology, Institute for Virus Research, Kyoto University, Kyoto 606 8507, Japan
J Vet Med Sci 74:347-50. 2012..We also found that RD-114 virus was stable physically and is capable of retaining its infectivity for a long period at -80°C...
- Influence of the glass packing on the contamination of pharmaceutical products by aluminium. Part III: Interaction container-chemicals during the heating for sterilisationDenise Bohrer
Departamento de Quimica, Universidade Federal de Santa Maria, Santa Maria, Brasil
J Trace Elem Med Biol 17:107-15. 2003..Experiments with complexing agents for Al allowed to conclude that the higher the stability constant of the complex, the higher the Al release from the container material...
- Metals in herbal drugs from Himalayan regionYogesh B Pakade
Hill Area Tea Science Division, Institute of Himalayan Bioresource Technology, Council of Scientific and Industrial Research CSIR, Palampur 176061, India
Bull Environ Contam Toxicol 86:133-6. 2011..The studied toxic elements were present in the herbal drugs (0.2-8.34 mg/kg As, 0.11-0.48 mg/kg Cd, 2.5-6.0 mg/kg Pb). Zinc was found in the range 7-32 mg/kg and all the samples were free from mercury contamination...
- Interaction of polysorbate 80 with erythropoietin: a case study in protein-surfactant interactionsAnnabelle P Villalobos
Biotech Development, Global Biological Supply Chain, 100 Route 202 South, Raritan, New Jersey 08869, USA
Pharm Res 22:1186-94. 2005..The purpose of this work was to repeat previously published studies in a more controlled manner and to define the precise nature of the interactions between polysorbate 80 and erythropoietin...
- Comparative evaluation of in vitro and in vivo assays for the detection of reticuloendotheliosis virus as a contaminant in a live virus vaccine of poultryA M Fadly
USDA Agricultural Research Service, East Lansing, MI 48823, USA
Avian Dis 41:695-701. 1997....
- Meeting report on protein particles and immunogenicity of therapeutic proteins: filling in the gaps in risk evaluation and mitigationJohn Carpenter
University of Colorado, Boulder, CO, USA
Biologicals 38:602-11. 2010....
- Iatrogenic Creutzfeldt-Jakob disease 22 years after human growth hormone therapy: clinical and radiological featuresM Furtner
J Neurol Neurosurg Psychiatry 79:229-31. 2008
- Impact of illegal trade on the quality of epoetin alfa in ThailandFotis Fotiou
Global Pharmaceutical Supply Group, Johnson and Johnson, Horsham, Pennsylvania, USA
Clin Ther 31:336-46. 2009..An investigation of anti-erythropoietin antibody-mediated pure red cell aplasia in Thailand found evidence of drug smuggling, which may have serious safety implications...
- Aluminum contamination of parenteral nutrition and aluminum loading in children on long-term parenteral nutritionEmmanuelle Advenier
Service de Pharmacie, Hopital Necker Enfants Malades, Pharmacie Centrale des Hôpitaux de Paris, 149 rue de Sevres, 75015 Paris, France
J Pediatr Gastroenterol Nutr 36:448-53. 2003..The aim of the present study is to determine the aluminum contamination of parenteral nutrition solutions and their components, and to assess the aluminum status of children on long-term parenteral nutrition...
- Influence of the glass packing on the contamination of pharmaceutical products by aluminium. Part II: amino acids for parenteral nutritionD Bohrer
Departamento de Quimica, Universidade Federal de Santa Maria, RS, Brazil
J Trace Elem Med Biol 15:103-8. 2001..The resuLts demonstrated that the contamination is an ongoing process due to the presence of aluminium in glass combined with the affinity of some amino acids for this element...
- Candidate cell substrates, vaccine production, and transmissible spongiform encephalopathiesPedro Piccardo
University of Edinburgh, Easter Bush, UK
Emerg Infect Dis 17:2262-9. 2011..In contrast, animals inoculated with cells exposed to the BSE agent remained asymptomatic. All cell lines we studied resisted infection with 3 TSE agents, including the BSE agent...
- An investigation into the microflora of heroinJ McLauchlin
Central Public Health Laboratory, Communicable Disease Surveillance Centre, London
J Med Microbiol 51:1001-8. 2002..subtilis alone and in one sample B. pumilus alone. C. botulinum and C. novyi were not isolated from any of the heroin samples. Recommendations for the optimal examination of the microflora of heroin are given...
- Determination of impurities in heparin by capillary electrophoresis using high molarity phosphate buffersTodd Wielgos
Baxter Healthcare Corporation, Round Lake, IL 60073, USA
J Pharm Biomed Anal 49:319-26. 2009..A high speed, high resolution version of the method was developed using 600mM lithium phosphate, pH 2.8 in a 21.5cm x 25microm i.d. capillary which provided limits of detection for OSCS that were below 0.1%...
- Outbreak of adverse reactions associated with contaminated heparinDavid B Blossom
Epidemic Intelligence Service Program, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA
N Engl J Med 359:2674-84. 2008..Preliminary findings suggested that heparin was a possible cause of the reactions...
- Authentication of the family Polygonaceae in Chinese pharmacopoeia by DNA barcoding techniqueJingyuan Song
Institute of Medicinal Plant Development, Chinese Academy of Medical Sciences, Peking Union Medical College, 151 Malianwa North Road, Haidian District, Beijing 100193, PR China
J Ethnopharmacol 124:434-9. 2009..Medicinal plants belonging to the family Polygonaceae in Chinese pharmacopoeia possess important medicinal efficacy in traditional Chinese medicines...
- Herbal remediesPeter A G M De Smet
Scientific Institute Dutch Pharmacists, The Hague, The Netherlands
N Engl J Med 347:2046-56. 2002
- Lead in pharmaceutical products and dietary supplementsJohn F Kauffman
U S Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Sciences, Division of Pharmaceutical Analysis, 1114 Market St, St Louis, MO 63101, USA
Regul Toxicol Pharmacol 48:128-34. 2007..Uniform lead limits that reflect current manufacturing capabilities are needed to insure the lowest achievable exposure to lead from these products...
- Determination of oversulfated chondroitin sulfate and dermatan sulfate impurities in heparin by capillary electrophoresisGovert W Somsen
Department of Biomedical Analysis, Utrecht University, P O BOX 80082, 3508 TB Utrecht, The Netherlands
J Chromatogr A 1216:4107-12. 2009..The CE method is shown to be repeatable and linear (R(2)>0.99) for OSCS, heparin and DS. CE analyses of OSCS-contaminated heparin samples and different heparin standards further demonstrate the utility of the method...
- Low incidence of SV40-like sequences in ependymal tumoursF J Reuther
Department of Pathology, University Hospitals of Ulm, Ulm, Germany
J Pathol 195:580-5. 2001..These differences may reflect different degrees of exposure to SV40-contaminated polio vaccine...
- Screening of heparin API by near infrared reflectance and Raman spectroscopyJohn A Spencer
Division of Pharmaceutical Analysis, Food and Drug Administration, Center for Drug Evaluation and Research, St Louis, Missouri 63101, USA
J Pharm Sci 98:3540-7. 2009..These technologies are meant for screening purposes and not meant to replace either of the methods (capillary electrophoresis and NMR) currently required by USP and FDA...
- Combined quantitative (1)H and (13)C nuclear magnetic resonance spectroscopy for characterization of heparin preparationsM Guerrini
G Ronzoni Institute for Chemical and Biochemical Research, Milan, Italy
Semin Thromb Hemost 27:473-82. 2001..Contaminants arising from industrial preparation processes are also detectable...
- Complications of traditional Chinese/herbal medicines (TCM)--a guide for perplexed oncologists and other cancer caregiversJoanne Chiu
Division of Hematology Oncology, Department of Medicine, The University of Hong Kong, Queen Mary Hospital, Pokfulam Rd, Pokfulam, Hong Kong
Support Care Cancer 17:231-40. 2009..If unrecognized, these problems may be misattributed to conventional treatment toxicity or disease progression, and remedial action may be inappropriate or delayed...
- Particulate and microbial contamination in in-use admixed parenteral nutrition solutionsShigeharu Oie
Department of Pharmacy, Yamaguchi University Hospital, 1 1 1 Minamikogushi, Ube 755 8505, Japan
Biol Pharm Bull 28:2268-70. 2005..01). On the other hand, none of the 199 samples showed bacteria or fungi/5 ml residual solution. Measures against particulate contamination of admixed parenteral nutrition solutions are necessary...
- Human and animal vaccine contaminationsPaul Pierre Pastoret
Publications Department, World Organisation for Animal Health, 12, rue de Prony, 75017 Paris, France
Biologicals 38:332-4. 2010....
- Analysis of pharmaceutical heparins and potential contaminants using (1)H-NMR and PAGEZhenqing Zhang
Department of Chemistry and Chemical Biology, Rensselaer Polytechnic Institute, Troy, New York 12180, USA
J Pharm Sci 98:4017-26. 2009..5-10%. Most of these heparinoids were stable to nitrous acid treatment suggesting its utility for evaluating impurities and contaminants in heparin API...
- A sensitive ELISA for the detection of bovine crude heparin in porcine heparinA Levieux
INRA, Station de Recherches sur la Viande, Immunochimie, Theix, , France
J Immunoassay Immunochem 22:323-36. 2001..Taking into account the variability of the background obtained for 10 crude and 9 pure porcine heparins from known origin, the detection level was 5 ppm. Ovine and caprine crude heparins cross-reacted slightly (6-17 ppm)...
- Bradykinin forming capacity of oversulfated chondroitin sulfate contaminated heparin in vitroAlbert Adam
Faculty of Pharmacy, Universite de Montreal, 2900, Boulevard E Montpetit, Montreal, QC H3T 1J4, Canada
Biomaterials 31:5741-8. 2010....
- Structure elucidation and biological activity of the oversulfated chondroitin sulfate contaminant in Baxter heparinJeff McKee
Baxter Healthcare, 25212 W Illinois Rt 120, WG2 1S, Round Lake, IL 60073, USA
J Clin Pharmacol 50:1159-70. 2010..These data provide insight into the etiology of the adverse events, particularly refractory hypotension, observed in patients who were exposed to heparin contaminated with OSCS...
- Toxic heavy metals and undeclared drugs in Asian herbal medicinesEdzard Ernst
Dept of Complementary Medicine, School of Sport and Health Sciences, University of Exeter, UK
Trends Pharmacol Sci 23:136-9. 2002..However, the majority of the data is anecdotal and insufficient to define prevalence figures. Ways ought to be found to maximize consumer safety...
- The tainted heparin story: an updateMarco Guerrini
Institute for Chemical and Biochemical Research, NMR Centre, Milan 20133, Italy
Thromb Haemost 102:907-11. 2009..As such, these techniques are powerful tools for the analysis and assessment of heparin preparations...
- Botanical medicines--the need for new regulationsDonald M Marcus
Baylor College of Medicine Houston, TX 77030, USA
N Engl J Med 347:2073-6. 2002
- Analysis of heparin sodium by SAX/HPLC for contaminants and impuritiesMichael L Trehy
Food and Drug Administration, Division of Pharmaceutical Analysis, Saint Louis, MO 63101, USA
J Pharm Biomed Anal 49:670-3. 2009..1% and 0.8%, respectively. This manuscript is not a policy document and is not intended to replace either of the methods (capillary electrophoresis and NMR) currently required by the FDA...
- Molecular and infectivity studies of porcine circovirus in vaccinesShasta D McClenahan
Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA CBER, Bethesda, MD 20892 4555, United States
Vaccine 29:4745-53. 2011..In these vaccines, molecular characterization of PCV nucleic acids was useful for predicting the results of cell culture assays...
- Identification of a simple and sensitive microplate method for the detection of oversulfated chondroitin sulfate in heparin productsShawn Bairstow
Technology Resources, Baxter Healthcare, 25212 W Illinois Rt 120, Round Lake, IL 60073, USA
Anal Biochem 388:317-21. 2009..1%, well below the NOEL. This kit may provide a useful method to test heparin products for contamination with oversulfated GAG derivatives...
- Endogenous retroviruses as potential hazards for vaccinesTakayuki Miyazawa
Laboratory of Signal Transduction, Department of Cell Biology, Institute for Virus Research, Kyoto University, 53 Shogoin Kawaracho, Sakyo ku, Kyoto 606 8507, Japan
Biologicals 38:371-6. 2010....
- Composition of OSCS-contaminated heparin occurring in 2008 in batches on the German marketTanja Beyer
Institute of Pharmacy and Food Chemistry, Julius Maximilians University of Wuerzburg, Am Hubland, D 97074 Wuerzburg, Germany
Eur J Pharm Sci 40:297-304. 2010..0. The presented analysis of a representative set of heparin samples proves the suitability of 1H NMR spectroscopy for the quality control of heparin of both glycosaminoglycans and residual solvents...
- Improved impurity fingerprinting of heparin by high resolution (1)H NMR spectroscopyPeter Bigler
University of Berne, Department of Chemistry and Biochemistry, Laboratory for NMR Spectroscopy, Bern, Switzerland
J Pharm Biomed Anal 49:1060-4. 2009....
- Methamphetamine impurity profiling using a 0.32 mm i.d. nonpolar capillary columnHiroyuki Inoue
National Research Institute of Police Science, 6 3 1, Kashiwanoha, Kashiwa shi, Chiba 277 0882, Japan
Forensic Sci Int 135:42-7. 2003..The results indicate that the present method would be useful for methamphetamine impurity profiling...
- Heparins: process-related physico-chemical and compositional characteristics, fingerprints and impuritiesLino Liverani
R and D Laboratories, Opocrin SpA, Corlo di Formigine Modena, Italy
Thromb Haemost 102:846-53. 2009....
- Lead-induced peripheral neuropathy following Ayurvedic medicationSurjit Singh
Department of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India
Indian J Med Sci 63:408-10. 2009..He was treated with d-Penicillamine for 8 weeks, following which his lead levels became normal. The use of d-Penicillamine was proved highly effective in treating a case of lead poisoning...
- Orthogonal analytical approaches to detect potential contaminants in heparinMarco Guerrini
Istituto di Richerche Chimiche e Biochimiche G Ronzoni, via Giuseppe Colombo 81, 20133 Milan, Italy
Proc Natl Acad Sci U S A 106:16956-61. 2009..We show that given the complexity of heparin samples, and the requirement to ensure their purity and safety, use of orthogonal analytical techniques is effective at detecting an array of potential contaminants that could be present...
- Contamination of infectious RD-114 virus in vaccines produced using non-feline cell linesRokusuke Yoshikawa
Laboratory of Signal Transduction, Department of Cell Biology, Institute for Virus Research, Kyoto University, 53 Shogoin Kawaracho, Sakyo ku, Kyoto 606 8507, Japan
Biologicals 39:33-7. 2011..To exclude RD-114 virus from live attenuated vaccines, we must pay attention to the contamination of seed viruses with RD-114 virus in addition to avoiding feline cell lines producing RD-114 virus when manufacturing vaccines...
- Identification and characterization of avian retroviruses in chicken embryo-derived yellow fever vaccines: investigation of transmission to vaccine recipientsAlthaf I Hussain
HIV and Retrovirology Branch, Division of AIDS, STD, and TB Laboratory Research, Centers for Disease Control and Prevention, Atlanta, Georgia 30333, USA
J Virol 77:1105-11. 2003..The absence of evidence of infection with ALV-E or EAV in 43 YF vaccine recipients suggests low risks for transmission of these viruses, further supporting the safety of these vaccines...
- Chinese proprietary medicine in Singapore: regulatory control of toxic heavy metals and undeclared drugsH L Koh
Department of Pharmacy, National University of Singapore
Drug Saf 23:351-62. 2000....
- Cancer risk associated with receipt of vaccines contaminated with simian virus 40: epidemiologic researchEric A Engels
Division of Cancer Epidemiology and Genetics, National Cancer Institute, DHHS, 6120 Executive Blvd, EPS 8010 Rockville, MD 20892, USA
Expert Rev Vaccines 4:197-206. 2005....
- Characterisation of Ag1, the major species-specific contaminant of bovine crude heparin, and its identification as an aprotinin/heparin complexVincent Rivera
INRA, Station de Recherches sur la Viande, Immunochimie, Theix, 63122 Saint Genes Champanelle, France
J Pharm Biomed Anal 29:443-58. 2002....
- Case report: potential arsenic toxicosis secondary to herbal kelp supplementEric Amster
School of Medicine, University of California Davis, One Shields Avenue, Davis, CA 95616, USA
Environ Health Perspect 115:606-8. 2007..Medicinal use of dietary herbal supplements can cause inadvertent arsenic toxicosis...
- Particulate and microbial contamination in in-use admixed intravenous infusionsKatsuhiro Yorioka
Department of Pharmacy, Saiseikai Yamaguchi University Hospital, Japan
Biol Pharm Bull 29:2321-3. 2006..No microbial contamination was observed in any of the residual solutions of 5 types of admixture...
- Phage passage after extended processing in small-virus-retentive filtersScott Lute
Division of Monoclonal Antibodies, Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, USA
Biotechnol Appl Biochem 47:141-51. 2007..Validation of filter performance with phages such as pp7 or PhiX-174 as models for small mammalian viruses represents an attractive alternative to the current practice...
- A multistate outbreak of Serratia marcescens bloodstream infection associated with contaminated intravenous magnesium sulfate from a compounding pharmacyRebecca H Sunenshine
Centers for Disease Control and Prevention, Arizona Dept of Health Services, 150 N 18th Ave, Ste 150, Phoenix, AZ 85007, USA
Clin Infect Dis 45:527-33. 2007..An investigation was initiated to determine whether there was a common underlying cause...
- A collaborative epidemiological investigation into the criminal fake artesunate trade in South East AsiaPaul N Newton
Centre for Tropical Medicine, Nuffield Department of Clinical Medicine, University of Oxford, Churchill Hospital, Oxford, United Kingdom
PLoS Med 5:e32. 2008....
- Trying times at the FDA--the challenge of ensuring the safety of imported pharmaceuticalsStuart O Schweitzer
Department of Health Services at the UCLA School of Public Health, Los Angeles, USA
N Engl J Med 358:1773-7. 2008
- Playing "kick the FDA"--risk-free to players but hazardous to public healthAlastair J J Wood
Symphony Capital, New York, USA
N Engl J Med 358:1774-5. 2008
- Hepatitis C virus infections from a contaminated radiopharmaceutical used in myocardial perfusion studiesPriti R Patel
Office of Workforce and Career Development, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA
JAMA 296:2005-11. 2006..Hepatitis C virus (HCV) transmission has not been reported previously in the setting of nuclear imaging studies...
- Outbreak of Serratia marcescens infections following injection of betamethasone compounded at a community pharmacyRachel Civen
Los Angles County Department of Health Services, Acute Communicable Disease Control Program, Los Angeles, CA 90012, USA
Clin Infect Dis 43:831-7. 2006..In June 2001, following the report of 4 patients with Serratia marcescens meningitis who received epidural injections of betamethasone compounded at a community pharmacy, we initiated an outbreak investigation...
- Impact of United States Pharmacopeia chapter 797: results of a national surveyTimothy A Candy
The Ohio State University OSU, USA
Am J Health Syst Pharm 63:1336-43. 2006..The initial response of the pharmacy profession to United States Pharmacopeia (USP) chapter 797 and the current state of hospital pharmacy practice as it relates to implementing this chapter were studied...
- Use of bacteriophages as surrogates for mammalian virusesM McAlister
Scientific and Laboratory Services SLS, Pall Corporation, Port Washington, NY 11050, USA
Dev Biol (Basel) 118:89-98. 2004..We propose that well-characterised bacteriophage, such as PP7 and PR772 can be used as models for mammalian viruses if the virus removal mechanism is based on size exclusion...
- Real time quantitative PCR as a method to evaluate xenotropic murine leukemia virus removal during pharmaceutical protein purificationLiming Shi
Process Sciences, Genentech, Inc, 1 DNA Way, South San Francisco, CA, USA
Biotechnol Bioeng 87:884-96. 2004..Its availability should greatly facilitate and reduce the cost of viral clearance evaluations for new biologic product development...
- USP chapter 797: establishing a practice standard for compounding sterile preparations in pharmacyEric S Kastango
Clinical IQ, LLC, Florham Park, NJ 07932, USA
Am J Health Syst Pharm 61:1928-38. 2004
- Quality and stability of TB medicines: let the buyer beware!Richard Laing
Int J Tuberc Lung Dis 8:1043-4. 2004
- Cancer incidence in Denmark following exposure to poliovirus vaccine contaminated with simian virus 40Eric A Engels
Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Department of Health and Human Services, Rockville, MD 20892, USA
J Natl Cancer Inst 95:532-9. 2003..To clarify whether SV40 infection increases risk of these cancers or of cancers arising in children, we examined cancer incidence in three Danish birth cohorts...
- Pharmacopoeial quality of drugs supplied by Nigerian pharmaciesR B Taylor
School of Pharmacy, The Robert Gordon University, Schoolhill, AB10 1FR, Aberdeen, UK
Lancet 357:1933-6. 2001..Substandard drugs sold in the pharmacies of less-developed countries could contribute to global microbial resistance and therapeutic failure of infectious diseases...
- Acanthamoeba keratitis and contact lens disinfecting solutionsK Tzanetou
Microbiology Laboratory, General Hospital of Athens G Gennimatas, Athens, Greece
Ophthalmologica 220:238-41. 2006..To report cases of culture-proved Acanthamoeba keratitis in Greece over a 10-year period and to evaluate the effectiveness of the commonly used commercial contact lens disinfecting systems in clinical cases of Acanthamoeba keratitis...
- Pseudomonas putida septicemia in a special care nursery due to contaminated flush solutions prepared in a hospital pharmacyJoseph F Perz
Centers for Disease Control and Prevention, Office of Workforce and Career Development, Epidemic Intelligence Service, Atlanta, Georgia 30333, USA
J Clin Microbiol 43:5316-8. 2005..These findings highlight the need for compliance with current standards of aseptic technique and quality assurance during the preparation of compounded sterile products...
- Effect of storage temperatures and time on the efficacy of multipurpose solutions for contact lensesPolly Leung
Biomedical Science Section, School of Nursing, The Hong Kong Polytechnic University, Kowloon, Hong Kong SAR, China
Ophthalmic Physiol Opt 24:218-24. 2004..To determine the effect of storage time and temperature on the efficacy of four multipurpose solutions for soft contact lenses...
- Lack of serologic evidence for prevalent simian virus 40 infection in humansJoseph J Carter
Fred Hutchinson Cancer Research Center, Seattle, WA 98109 1024, USA
J Natl Cancer Inst 95:1522-30. 2003..To test this hypothesis, we screened human sera for antibodies to SV40 using direct and competitive enzyme-linked immunosorbent assays (ELISAs)...
- Murder by fake drugsPaul N Newton
BMJ 324:800-1. 2002
- Life-threatening sepsis caused by Burkholderia cepacia from contaminated intravenous flush solutions prepared by a compounding pharmacy in another stateMelissa R Held
Department of Pediatrics, Division of Infectious Diseases, Yale University School of Medicine, New Haven, Connecticut, USA
Pediatrics 118:e212-5. 2006..Proper quality controls at a local and national level are important for ensuring safe delivery of compounded medications to patients in all settings, including those outside health care facilities...
- Is there an association between SV40 contaminated polio vaccine and lymphoproliferative disorders? An age-period-cohort analysis on Norwegian data from 1953 to 1997Guri Olsen Thu
The Cancer Registry of Norway Institute of Population based Cancer Research, Montebello, Oslo, Norway
Int J Cancer 118:2035-9. 2006..Thus, our data do not support the hypothesis of an association between the vaccine and any subgroup of lymphoproliferative diseases...
- Absence of SV40 in Austrian tumors correlates with low incidence of mesotheliomasAndreas Leithner
Department of Orthopedic Surgery, Karl Franzens University, Graz, Austria
Cancer Biol Ther 1:375-9. 2002..Our findings support the notion that: 1) polio vaccination is the main source for SV40 in human populations, 2) Austria was not exposed to SV40, and 3) its absence correlates with the low incidence of mesotheliomas in Austria...
- Silicone-free glass pre-filled syringe system for Biological Drugs.VINAY G SAKHRANI; Fiscal Year: 2013..The proposed TriboGlide(R) system will be the first silicone-free system for glass prefilled syringes that overcomes the problems of lubricant migration and drug contamination.
- Validation of LC-MS/MS analyses of animal tissue and feed matrices for toxicantsCYNTHIA LYNN GASKILL; Fiscal Year: 2013..safety of human and animal health by investigating potential adverse events involving animal feed or animal drug contamination or adulteration...
- Silicone-free glass pre-filled syringe system for Biological Drugs.VINAY SAKHRANI; Fiscal Year: 2009..The proposed TriboGlide system will be the first silicone oil-free system for glass prefilled syringes that overcomes the problems of lubricant migration and drug contamination.
- MATRIX-ASSISTED LASER DESORPTION TOF MASS SPECTROMETERRichard van Breemen; Fiscal Year: 2001..abstract_text> ..
- The Bioavilaibility of Folate in HumansRichard van Breemen; Fiscal Year: 2004..Our new LC-MS-MS assay and the use of 13C-labeled folate species will provide new and more detailed information on the uptake, metabolism, and bioavailability of folates than has been possible previously. ..
- HPLC time-of-flight mass spectrometer for accurate mass measurementsRichard van Breemen; Fiscal Year: 2007..to natural product chemists and synthetic organic chemists in the user community who rely upon rapid analyses of their compounds in order to advance with their NIH-funded research programs [unreadable] [unreadable] [unreadable]..
- Mechanisms of prostate cancer prevention by lycopeneRichard van Breemen; Fiscal Year: 2007..These human studies will provide vital information for the design of future clinical trials investigating the chemoprevention of prostate cancer by lycopene. [unreadable] [unreadable] [unreadable]..
- 2D-HPLC-Tandem Mass Spectrometer for ProteomicsRichard van Breemen; Fiscal Year: 2005..Overall, the proposed 2D mu LC-MS/MS instrument will complement the existing proteomics resources on campus and will enhance the current research of NIH-funded users by providing analytical capabilities currently unavailable on campus. ..
- Microglial Cell Activation by Thrombin in StrokeJonathan Weinstein; Fiscal Year: 2008..unreadable] [unreadable]..
- Ethanol and mesolimbic GABAergic neuronsJiang Hong Ye; Fiscal Year: 2007..Such results will provide valuable information on novel mechanisms underlying the addictive properties of alcohol and a firm scientific foundation for future neurobiological studies. [unreadable] [unreadable] [unreadable]..
- SV40 Pathogenesis of Human InfectionsJANET BUTEL; Fiscal Year: 2008..This new information will allow better understanding of the biology of SV40 human infections and may provide insights into the mechanisms of SV40 involvement in human malignancies. [unreadable] [unreadable]..
- Plasmodium Falciparum Metal MetabolismDavid Sullivan; Fiscal Year: 2009..Plasmodium parasitism provides a comparison of "simple" erythrocyte cell to more complex infected cell. ..
- Case CFAR Meeting: HIV PathogenesisMichael Lederman; Fiscal Year: 2006..Presentation sessions will be Cellular Restrictions Factors; Latency; Protection from HIV Infection; Immune Pathogenesis; and Vaccines. ..
- Impact of Drug Policy Reform on the HIV Risk Environment among IDUs in TijuanaSteffanie A Strathdee; Fiscal Year: 2010....
- N-acetylcysteine pharmacokinetics--hemodialysis patientsRichard Ward; Fiscal Year: 2006..abstract_text> ..
- Club Drugs/Resource Inequity/Health Risk in Urban YouthJean Schensul; Fiscal Year: 2005..The study promises to produce new analytic and theoretical insights into the diffusion of new drugs into already saturated urban youth drug markets and the consequences of their use. ..
- Topical Immune modulatory strategies to prevent HIV transmissionMichael Lederman; Fiscal Year: 2007..unreadable] [unreadable] [unreadable]..
- Direct Enantiomer Separation in Immunoaffinity SystemsOliver Hofstetter; Fiscal Year: 2003..Chromatographic parameters will be optimized in order to adjust separation conditions to the strength of interaction between antibody and analyte. ..
- BUILDING PREVENTIVE GROUP NORMS IN URBAN MIDDLE SCHOOLSJean Schensul; Fiscal Year: 2003..Years 4 and 5 will be utilized to collect the final outcome assessment data, to analyze and triangulate data and to finalize curriculum and publications. ..
- EFFECTS OF PARTNER VIOLENCE VICTIMIZATION IN DRUG USEMerrill Singer; Fiscal Year: 2002....
- ETHANOL EFFECTS ON GLYCINE RECEPTOR/CHANNEL FUNCTIONJiang Hong Ye; Fiscal Year: 2003....
- Hamster Model for AIDS LymphomasJANET BUTEL; Fiscal Year: 2003..In addition, this project may provide new insights into lymphomagenesis in general and may lead to the development of new diagnostic and therapeutic approaches to this malignancy. ..
- SYRINGE ACCESS AND HIV RISKMerrill Singer; Fiscal Year: 2002..g., high or low availability of sterile syringes) and actual risk factors (e.g., frequency of infected syringes in circulation). ..
- AIDS RISK IN OLDER URBAN ADULT SENIOR HOUSING RESIDENTSJean Schensul; Fiscal Year: 2002..abstract_text> ..
- Neurobiol mechanism/acupuncture therapy/alcoholismJiang Hong Ye; Fiscal Year: 2004..This new knowledge will have a major impact on our understanding of how acupuncture works. The application of this knowledge is expected to improve the effectiveness of acupuncture treatment in alcohol addiction. ..
- DETERMINING/UNDERSTANDING BARRIERS TO ADULT IMMUNIZATIONRichard Zimmerman; Fiscal Year: 2001..This project will furnish relevant, up-to-date to enhance policy planning, practice management and medical education. ..
- Immune Mechanisms and HIV Disease PathogenesisMichael Lederman; Fiscal Year: 2004..The proposal's specific request is for support to increase participation in the Conference by female and/or minority researchers and students. ..
- IMMUNOGENETIC MECHANISMS OF VACCINE RESPONSEGregory A Poland; Fiscal Year: 2010..The knowledge gained from these studies will enable us to design new strategies and new vaccines to protect human health against viral diseases. ..
- MDMA and STD/HIV Risk among Hidden Networks of Ecstasy-using Young AdultsJean Schensul; Fiscal Year: 2009....
- PATHWAYS TO HIGH RISK DRUG ABUSE AMONG URBAN YOUTHJean Schensul; Fiscal Year: 2001....
- The Medical Consequences of Different Types of HeroinDaniel Ciccarone; Fiscal Year: 2008..e., soft tissue infection, HIV and heroin related overdose. [unreadable] [unreadable] [unreadable] [unreadable]..
- ENHANCING MUCOSAL IMMUNE RESPONSES BY MICROENCAPSULATIONPaul Offit; Fiscal Year: 2005..The availability of microencapsulated virus provides a unique opportunity to understand the relationship between APC and protective mucosal immune responses. ..
- MINORITY YOUTH ACTION RESEARCH TRAINING INSTITUTEJean Schensul; Fiscal Year: 2002....
- 2007 Case CFAR Annual Spring ConferenceMichael Lederman; Fiscal Year: 2007..The Case CFAR is proactive in its efforts to ensure inclusion of minority and female researchers in[unreadable] all aspects of Conference planning and attendance. ..
- CONFERENCE ON HIV PATHOGENESISMichael Lederman; Fiscal Year: 2005....
- Alcohol, Risky Behavior and HIV Prevention in Mumbai, IndiaJean Schensul; Fiscal Year: 2007....
- Statistical Methods to Study the Epidemiology of HIV & Other DiseaseNicholas P Jewell; Fiscal Year: 2010....
- Statistical Techniques for Complex Environmental Epidemiological StudiesNicholas P Jewell; Fiscal Year: 2010....
- Prevention of Healthcare-Associated Drug-Resistant GNRLisa Maragakis; Fiscal Year: 2006..Maragakis with the skills she needs to develop into an independent clinical investigator in epidemiologic research for the prevention of healthcare-associated infections. ..
- Susceptibility Testing, Treatment Choices, and Outcomes of MDR-GNB InfectionsLisa Maragakis; Fiscal Year: 2009..This research is designed to better understand how providers use information from various microbiology laboratory testing methods to choose treatments and to identify strategies that lead to the best patient outcomes. ..
- ANESTHETIC RENAL METABOLISM--MECHANISMS AND CONSEQUENCESEvan Kharasch; Fiscal Year: 2002..More broadly, resulting biochemical and clinical insights will be applicable to the numerous other nephrotoxic haloalkenes that are ubiquitous environmental contaminants. ..
- Mechanism of in-vitro agingLYSLE LEWIS; Fiscal Year: 2007..The proposed research will enhance our understanding of events that occur as a consequence of shortened chromosomes and factors that affect the rate of shortening. [unreadable] [unreadable] [unreadable]..
- Novel noninvasive assessment of cytochrome P450 activityEvan Kharasch; Fiscal Year: 2009..This approach may identify inter-individual variability in drug disposition and response;permit more individualized dosing, and reduces the cost of drug interaction studies. ..
- Reduce Transmission Risks & Improve HCV Treatment AccessSteffanie Strathdee; Fiscal Year: 2004....
- BALTIMORE NEEDLE EXCHANGE PROGRAM EVALUATIONSteffanie Strathdee; Fiscal Year: 2004..In meeting the above specific aims, the proposed study will have an important impact on policies surrounding NEP in the United States and elsewhere. ..