Bioequivalence

Results: 910



#Item
391Amines / Eli Lilly and Company / Antitussives / Dextropropoxyphene / Propionates / Paracetamol / Aspirin / Bioequivalence / Pharmacology / Chemistry / Medicine

Chen: History and Efficacy of Propoxyphene Products

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Source URL: www.fda.gov

Language: English
392Clinical research / Bioequivalence / Pharmacokinetics / Pharmaceuticals policy / Abbreviated New Drug Application / Generic drug / Center for Drug Evaluation and Research / Pharmaceutical sciences / Pharmacology / Food and Drug Administration

Disclaimer Statement The attached package contains background information prepared by the Food and Drug Administration (FDA) for the panel members of the advisory committee. The FDA background package might contain asses

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Source URL: www.fda.gov

Language: English
393Pharmaceutical industry / Clinical pharmacology / Clinical research / Abbreviated New Drug Application / Bioequivalence / Package insert / Medical prescription / Drug Identification Number / Packaging and labeling / Pharmaceutical sciences / Pharmacology / Medicine

Preparation of Drug Identification Number Submissions

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Source URL: hc-sc.gc.ca

Language: English - Date: 2013-07-12 14:25:56
394Dosage forms / Clinical research / Pharmacokinetics / Medicinal chemistry / Bioequivalence / Abbreviated New Drug Application / Nasal administration / Bioavailability / Drug delivery / Pharmaceutical sciences / Pharmacology / Medicine

Microsoft Word - 2003guidance_redo_10[removed]doc

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Source URL: www.fda.gov.

Language: English
395Pharmacy / Medicinal chemistry / Clinical research / Bioequivalence / Bioavailability / Pharmacodynamics / Food and Drug Administration / Sarfaraz K. Niazi / Phases of clinical research / Pharmaceutical sciences / Pharmacology / Pharmacokinetics

U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may

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Source URL: www.fda.gov

Language: English
396Antifungals / Amphotericin B / Euglenozoa / Visceral leishmaniasis / Liposome / Leishmaniasis / Leishmania / Bioequivalence / Medicine / Microbiology / Biology

Different liposomal amphotericin B formulations for visceral leishmaniasis

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Source URL: fieldresearch.msf.org

Language: English - Date: 2014-08-26 03:32:19
397Medicine / Pharmacokinetics / Clinical research / Pharmaceuticals policy / Bioequivalence / Food and Drug Administration / Generic drug / Dissolution testing / Abbreviated New Drug Application / Pharmaceutical sciences / Pharmacology / Pharmaceutical industry

Microsoft Word - Comprehensive List Of Guidances_10-1-14.doc

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Source URL: www.fda.gov.

Language: English
398Pharmaceutical industry / Pharmaceutics / Food and Drug Administration / Bioequivalence / Pharmacokinetics / Generic drug / Abbreviated New Drug Application / NIPTE / Center for Drug Evaluation and Research / Pharmaceutical sciences / Pharmacology / Pharmaceuticals policy

Generic Drug User Fee Amendments of 2012 Regulatory Science Initiatives:

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Source URL: www.fda.gov

Language: English
399Pharmacokinetics / Pharmacy / Pharmaceutical industry / Pharmaceuticals policy / Generic drug / Food and Drug Administration / Bioequivalence / Physiologically based pharmacokinetic modelling / Colon cleansing / Pharmaceutical sciences / Pharmacology / Medicine

Regulatory Applications of Modelling and Simulations at FDA Robert Lionberger Office of Generic Drugs Opinions expressed in this presentation are those of the speaker and do not necessarily reflect

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Source URL: www.thehamner.org

Language: English - Date: 2010-12-20 17:37:32
400Clinical research / Research / Pharmaceuticals policy / Food and Drug Administration / Therapeutics / Generic drug / Bioequivalence / European Medicines Agency / Pharmaceutical sciences / Pharmacology / Pharmaceutical industry

Terms of engagement EMA-EU MSs-FDA initiative on inspections for Generic Applications

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Source URL: www.fda.gov.

Language: English
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