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Bioequivalence
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381	Center for Drug Evaluation and Research Meeting of the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology August 8, 2012 Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutics Clinical research Quality Dissolution testing Bioequivalence Food and Drug Administration In vivo Quality by Design Biosimilar Pharmaceutical sciences Pharmaceutical industry Pharmacology
382	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 Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutics Clinical research Bioequivalence Generic drug Bioavailability Dose Food and Drug Administration Abbreviated New Drug Application Pharmaceutical sciences Pharmacology Pharmacokinetics
383	Use and Limitations of In Vitro Dissolution Testing: Topic Introduction and Overview Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical industry Quality control Pharmaceutics Food and Drug Administration IVIVC Pharmacokinetics Bioequivalence Dissolution In vitro Pharmaceutical sciences Pharmacology Dissolution testing
384	AACE TES ATA PosStatement Re Thyroxine Products.DOC Add to Reading List Source URL: www.aace.com Language: English - Date: 2011-02-15 11:19:57 Clinical research Pharmaceutical industry Food and Drug Administration Thyroid disease Levothyroxine Abbreviated New Drug Application Desiccated thyroid extract Thyroid hormone Bioequivalence Pharmacology Anatomy Pharmaceutical sciences
385	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 Add to Reading List Source URL: www.fda.gov Language: English Clinical pharmacology Food and Drug Administration Therapeutics United States Public Health Service Bioequivalence Dose Pharmacology Pharmaceutical sciences Clinical research
386	Microsoft Word - APPROVED - Guidance_Preparation of vet ANDS, dec[removed]English-revised coverpage.rtf Add to Reading List Source URL: hc-sc.gc.ca Language: English - Date: 2013-06-24 11:48:49 Pharmaceutics Pharmacology Pharmaceuticals policy Bioequivalence Pharmacokinetics Abbreviated New Drug Application Generic drug Validation Health Canada Pharmaceutical industry Pharmaceutical sciences Clinical research
387	Use of partiaL AUC: Case Studies & BE Approaches Add to Reading List Source URL: www.fda.gov Language: English Generic drug Bioequivalence Food and Drug Administration Abbreviated New Drug Application Approved Drug Products with Therapeutic Equivalence Evaluations Bioavailability Pharmaceutical drug Pharmaceutical sciences Pharmacology Pharmacokinetics
388	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 Add to Reading List Source URL: www.fda.gov Language: English Research Bioequivalence Clinical research Bioavailability Confidence interval Food and Drug Administration Dose Pharmaceutical sciences Pharmacology Pharmacokinetics
389	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 Add to Reading List Source URL: www.fda.gov Language: English Pharmacy Pharmaceuticals policy Pharmaceutical industry Generic drug Bioequivalence Food and Drug Administration Abbreviated New Drug Application Therapeutic drug monitoring Bioavailability Pharmaceutical sciences Pharmacology Pharmacokinetics
390	HEALTH CANADA USE ONLY Sponsors should address the points outlined below by answering “Yes”, “No”, or “Not Applicable”, providing a justification where required, and completing the requested information. This Add to Reading List Source URL: hc-sc.gc.ca Language: English - Date: 2014-01-13 12:58:35 Pharmaceutics Pharmacokinetics Clinical research Validity Abbreviated New Drug Application Bioequivalence Validation Bioavailability Verification and validation Pharmaceutical sciences Pharmaceutical industry Pharmacology

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