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Bioequivalence
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#	Item
831	Microsoft Word - 10375dft.doc Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Pharmaceuticals policy Medicine Clinical research Abbreviated New Drug Application New Drug Application Title 21 CFR Part 11 Generic drug Bioequivalence Pharmaceutical sciences Pharmaceutical industry Food and Drug Administration
832	Guidance for Industry Nonsterile Semisolid Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Research Clinical pharmacology Food and Drug Administration Bioequivalence Abbreviated New Drug Application In vitro Excipient Validation Pharmaceutical sciences Clinical research Pharmaceutical industry
833	Microsoft Word - 10472dft.doc Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical industry Pharmacokinetics Clinical research Drug safety Bioequivalence Abbreviated New Drug Application Food and Drug Administration Dissolution testing New Drug Application Pharmaceutical sciences Pharmacology Pharmaceutics
834	DIVISION OF BIOEQUIVALENCE REVIEW Add to Reading List Source URL: www.fda.gov Language: English Phenols Organofluorides Chemistry Ezetimibe Pharmacology Pharmaceutics Statin Bioequivalence Dissolution testing Merck Pharmaceutical industry Schering-Plough
835	Guidance for Industry Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical industry Dissolution testing Quality control Pharmacokinetics IVIVC Bioequivalence In vitro Abbreviated New Drug Application Food and Drug Administration Pharmaceutical sciences Pharmacology Pharmaceutics
836	Guidance for Industry Exposure-Response Relationships — Study Design, Data Analysis, and Regulatory Applications U.S. Department of Health and Human Services Add to Reading List Source URL: www.fda.gov Language: English Pharmacokinetics Clinical research Toxicology Design of experiments Dose-response relationship Bioequivalence Bioavailability Methadone Clinical trial Pharmaceutical sciences Pharmacology Medicine
837	Guidance for Industry Immediate Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls, In Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutics Clinical research Dosage forms Pharmacokinetics Dissolution testing Bioequivalence Food and Drug Administration Excipient Generic drug Pharmaceutical sciences Pharmaceutical industry Pharmacology
838	DIVISION OF BIOEQUIVALENCE REVIEW Add to Reading List Source URL: www.fda.gov Language: English Dosage forms Transdermal patches Dermal patch Allergy Topical Estrogen patch Medicine Pharmacology Pharmaceutical sciences
839	Microsoft Word - 071368C1007 Add to Reading List Source URL: www.fda.gov Language: English Membrane biology Pharmaceutical industry Antifungals Amphotericin B Bioequivalence Liposome Dissolution testing Abbreviated New Drug Application Generic drug Pharmacology Pharmaceutical sciences Pharmacokinetics
840	N20-896S032 Capecitabine Clinpharm BPCA Add to Reading List Source URL: www.fda.gov Language: English Chemistry Pharmacokinetics Capecitabine Carbamates Prodrugs Pharmacy Fluorouracil Bioequivalence Pharmacology Organofluorides Pharmaceutical sciences

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