Bioequivalence

Results: 910



#Item
401Medicinal chemistry / Pharmaceutical industry / Clinical research / Biopharmaceutics Classification System / Bioavailability / Dissolution testing / Absorption / Bioequivalence / Drug discovery / Pharmaceutical sciences / Pharmacology / Pharmacokinetics

Guidance for Industry Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System

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Source URL: www.fda.gov.

Language: English
402Food and Drug Administration / Clinical research / Pharmacy / Center for Drug Evaluation and Research / Generic drug / Bioequivalence / Abbreviated New Drug Application / Drug development / Drug discovery / Pharmaceutical sciences / Pharmacology / Pharmaceutical industry

CDER: Overview of Pre- and Post-Market Programs

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Source URL: www.fda.gov.

Language: English
403Chemistry / Food and Drug Administration / IVIVC / Bioequivalence / Pharmaceutical sciences / Biopharmaceutics Classification System / In vivo / Lamotrigine / Abbreviated New Drug Application / Anticonvulsants / Mood stabilizers / Pharmacology

Biopharmaceutics Risk of OrallyAdministered Products FY 2014 GDUFA Regulatory Science Initiatives Part 15 Public Meeting Silver Spring, MD James E. Polli and Tricia Ting

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Source URL: www.fda.gov

Language: English
404Research / Clinical research / Pharmaceuticals policy / Generic drug / Public domain / Food and Drug Administration / Abbreviated New Drug Application / Bioequivalence / Excipient / Pharmaceutical sciences / Pharmacology / Pharmaceutical industry

Inactive Ingredient Database - FDA Update - Robert Iser Director for Chemistry Division IV Office of Generic Drugs

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Source URL: www.fda.gov.

Language: English
405Research / Pharmaceutical industry / Food and Drug Administration / Clinical pharmacology / Abbreviated New Drug Application / Bioequivalence / Generic drug / New Drug Application / Center for Drug Evaluation and Research / Pharmaceutical sciences / Pharmacology / Clinical research

Microsoft Word - 8857fnl.doc

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Source URL: www.fda.gov.

Language: English
406Clinical research / Clinical pharmacology / Pharmaceuticals policy / Generic drug / Abbreviated New Drug Application / Food and Drug Administration / Bioequivalence / New Drug Application / Drug discovery / Pharmaceutical sciences / Pharmacology / Pharmaceutical industry

The committee will discuss saxagliptin tablets, by Bristol-Myers Squibb, for the treatment of hyperglycemia in adults with type 2 diabetes mellitus

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Source URL: www.fda.gov

Language: English
407Research / Clinical research / Pharmaceutical industry / Bioequivalence / Pharmacokinetics / Generic drug / Center for Drug Evaluation and Research / Pharmaceutical sciences / Pharmacology / Food and Drug Administration

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. This content has not been altered or updated since it was archived

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Source URL: www.fda.gov

Language: English
408Norbrook / Organofluorides / Pharmacology / Ketones / Non-steroidal anti-inflammatory drug / Meglumine / Bioequivalence / Methadone / Chemistry / Organic chemistry / Flunixin

Microsoft Word[removed]387foi.doc

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Source URL: www.fda.gov

Language: English
409Food and Drug Administration / Clinical research / Pharmaceutical industry / Abbreviated New Drug Application / Generic drug / Bioequivalence / Center for Drug Evaluation and Research / Prescription Drug User Fee Act / Pharmaceutical sciences / Pharmacology / Pharmaceuticals policy

Microsoft PowerPoint[removed]18GJB_GPhA.ppt

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Source URL: www.fda.gov

Language: English
410Tylosin / Center for Veterinary Medicine / Monensin / Eimeria / Food and Drug Administration / Ionophore / Bioequivalence / Acetate / Pharmacology / Pharmaceutical sciences / Medicine

Date of Approval:November 30, 2012 FREEDOM OF INFORMATION SUMMARY ORIGINAL ABBREVIATED NEW ANIMAL DRUG APPLICATION ANADA[removed]

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Source URL: www.fda.gov

Language: English
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