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Bioequivalence
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361	Microsoft Word[removed]4R.doc Add to Reading List Source URL: www.fda.gov Language: English Research Food and Drug Administration Pharmaceutics Pharmacokinetics Abbreviated New Drug Application Bioequivalence Epidemiology Generic drug Clinical trial Clinical research Pharmaceutical industry Pharmaceutical sciences
362	Guidance for Industry Controlled Correspondence Related to Generic Drug Development DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Add to Reading List Source URL: www.fda.gov Language: English Clinical research Research Food and Drug Administration Pharmaceuticals policy Therapeutics New Drug Application Generic drug Bioequivalence Pharmaceutical sciences Pharmaceutical industry Pharmacology
363	FOOD AND DRUG ADMINISTRATION PROGRAM[removed] Add to Reading List Source URL: www.fda.gov Language: English Research Pharmacology Food and Drug Administration Drug safety Bioequivalence Abbreviated New Drug Application Generic drug Clinical trial Clinical site Clinical research Pharmaceutical industry Pharmaceutical sciences
364	UNITED STATES OF AMERICAPRIVATE FOOD & DRUG ADMINISTRATION Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical industry Clinical research Pharmacokinetics Pharmacy Bioequivalence Abbreviated New Drug Application Generic drug Food and Drug Administration Drug Price Competition and Patent Term Restoration Act Pharmaceutical sciences Pharmacology Pharmaceutics
365	A Primer on Generic Drugs and Bioequivalence: an overview of the generic drug approval process Division of Bioequivalence II Reviewer Add to Reading List Source URL: www.fda.gov Language: English Clinical research Pharmaceuticals policy Abbreviated New Drug Application Generic drug Drug Price Competition and Patent Term Restoration Act Food and Drug Administration Bioequivalence Roche Products v. Bolar Pharmaceutical New Drug Application Pharmaceutical sciences Pharmacology Pharmaceutical industry
366	Date of Approval: May 8, 2014 FREEDOM OF INFORMATION SUMMARY ORIGINAL ABBREVIATED NEW ANIMAL DRUG APPLICATION ANADA[removed] Add to Reading List Source URL: www.fda.gov Language: English Bioequivalence Quinolone Norbrook Group Chemistry Piperazines Cyclopropanes Enrofloxacin
367	FY 14 GDUFA Regulatory Research Priorities Add to Reading List Source URL: www.fda.gov Language: English Pharmacokinetics Pharmaceutical industry Clinical research Pharmaceuticals policy Abbreviated New Drug Application Bioequivalence Food and Drug Administration Generic drug New Drug Application Pharmaceutical sciences Pharmacology Pharmaceutics
368	Date of Approval: September 21, 2014 FREEDOM OF INFORMATION SUMMARY ORIGINAL ABBREVIATED NEW ANIMAL DRUG APPLICATION ANADA[removed] Add to Reading List Source URL: www.fda.gov Language: English Amides Cat health Meloxicam Organic chemistry Pharmacology Chemistry Bioequivalence Non-steroidal anti-inflammatory drugs Dog health Thiazoles
369	Date of Approval: July 12, 2014 FREEDOM OF INFORMATION SUMMARY ORIGINAL ABBREVIATED NEW ANIMAL DRUG APPLICATION ANADA[removed] Add to Reading List Source URL: www.fda.gov Language: English Carprofen Dog health Organochlorides Ketones Pharmacology Drug rehabilitation Bioequivalence Norbrook Group Methadone Chemistry Non-steroidal anti-inflammatory drugs Organic chemistry
370	Clinical Pharmacokinetics BLA: 961433, recombinant human Interleukin Review Add to Reading List Source URL: www.fda.gov Language: English Oprelvekin Bioequivalence Bioavailability Pharmacokinetics Pharmacology Pharmaceutical sciences

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