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Bioequivalence
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#	Item
311	Bioequivalence of Oral Generic Product with An Alternate Administration Minglei Cui, Ph.D. CDR, U.S. Public Health Service Division of Bioequivalence 2 Add to Reading List Source URL: www.fda.gov Language: English Proton pump inhibitors Benzimidazoles Pyridines Sulfoxides Esomeprazole Omeprazole Bioequivalence Lansoprazole Generic drug Pharmacology Chemistry Pharmaceutical sciences
312	Developing New Bioequivalence Approaches for Complex Products Robert Lionberger, Ph.D. Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutics Pharmaceutical industry Clinical research Abbreviated New Drug Application Pharmaceuticals policy Bioequivalence Generic drug Food and Drug Administration Pharmaceutical sciences Pharmacology Pharmacokinetics
313	UKPAR Lacidipine 2 and 4 mg Film-Coated Tablets PL[removed]0503 Lacidipine 2 mg Film-Coated Tablets PL[removed] Add to Reading List Source URL: www.mhra.gov.uk Language: English - Date: 2014-10-16 10:50:12 Pharmaceutical industry Dosage forms Clinical research Ketones Tablet Excipient Bioequivalence Abbreviated New Drug Application Generic drug Chemistry Pharmacology Organic chemistry
314	Generics Versus Generics: Bioequivalence To Brand-Name Version Means Bioequivalence Between Generics The Issue: In an attempt to retain sales of their drugs after the loss of market monopolies, some brand-name drug compa Add to Reading List Source URL: www.canadiangenerics.ca Language: English - Date: 2014-10-07 10:55:08 Pharmaceuticals policy Pharmaceutics Abbreviated New Drug Application Generic drug Bioequivalence Pharmaceutical drug Food and Drug Administration Automatic Generic Substitution Pharmaceutical sciences Pharmacology Pharmaceutical industry
315	Médicaments génériques comparés aux médicaments génériques : la bioéquivalence avec la version de marque implique la bioéquivalence entre les médicaments génériques Enjeu : Pour compenser la chute des recette Add to Reading List Source URL: www.canadiangenerics.ca Language: French - Date: 2014-10-07 10:55:08
316	FY 2014 Awarded GDUFA Regulatory Research Contracts and Grants Characterization of Epilepsy Patients at Risk for Adverse Outcomes Related to Switching Antiepileptic Drug Products • Awarded to the University of Maryland Add to Reading List Source URL: www.fda.gov Language: English Pharmacy Generic drug Abbreviated New Drug Application Bioequivalence Physiologically based pharmacokinetic modelling Food and Drug Administration Pharmacodynamics In vivo Methylphenidate Pharmaceutical sciences Pharmacology Pharmacokinetics
317	FY 2013 Awarded GDUFA Regulatory Research Contracts and Grants FY2014 Extension or Expansion Development of In Vivo Predictive Dissolution Method for Orally Inhaled Drug Products • Multiple Awards to: University of Bat Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutics Pharmaceutical industry Bioequivalence Clinical research IVIVC Bupropion Abbreviated New Drug Application Generic drug In vitro Pharmacology Pharmaceutical sciences Pharmacokinetics
318	This report contains the collective views of an international group of experts and does not necessarily represent the decisions or the stated policy of the World Health Organization WHO Technical Report Series 929 Add to Reading List Source URL: apps.who.int Language: English - Date: 2006-11-21 08:37:58 Pharmaceutical industry Research Pharmaceuticals policy Combination drug Good manufacturing practice Bioequivalence Regulatory requirement Committee for Medicinal Products for Human Use Pharmacovigilance Pharmaceutical sciences Pharmacology Clinical research
319	CMD(h)CMDh BEST PRACTICE GUIDE ON THE COMPILATION OF THE DOSSIER FOR NEW APPLICATIONS SUBMITTED IN MUTUAL RECOGNITION & DECENTRALISED PROCEDURES Doc. Ref.: CMDh[removed]Rev.1 Add to Reading List Source URL: www.hma.eu Language: English - Date: 2014-10-10 05:13:04 Pharmaceutical sciences Health EudraLex Summary of Product Characteristics European Directive on Traditional Herbal Medicinal Products Medicinal product Directive 2001/83/EC Validation Bioequivalence Pharmaceuticals policy Clinical research Research
320	CMDh BEST PRACTICE GUIDE ON THE COMPILATION OF THE DOSSIER FOR NEW APPLICATIONS SUBMITTED IN MUTUAL RECOGNITION & DECENTRALISED PROCEDURES Doc. Ref.: CMDh[removed]Rev.1 September 2014 Add to Reading List Source URL: www.hma.eu Language: English - Date: 2014-10-10 05:13:04 Research Pharmacology Summary of Product Characteristics EudraLex Bioequivalence Test data exclusivity European Directorate for the Quality of Medicines Supplementary protection certificate Pharmaceuticals policy Clinical research Pharmaceutical sciences

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