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Bioequivalence
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#	Item
581	“Nanosimilars” Scott McNeil Director, NCL May 16, 2014 http://ncl.cancer.gov Add to Reading List Source URL: www.fda.gov Language: English Clinical research Anthracyclines Doxorubicin Pharmaceutical industry Biotechnology Liposome Biosimilar Biologic Bioequivalence Medicine Pharmacology Chemistry
582	Guidance Document: Conduct and Analysis of Comparative Bioavailability Studies Add to Reading List Source URL: www.hc-sc.gc.ca Language: English - Date: 2013-06-24 11:52:38 Clinical research Research Pharmaceuticals policy Pharmaceutical industry Bioavailability Bioequivalence Regulatory requirement Abbreviated New Drug Application Clinical trial Pharmaceutical sciences Pharmacology Pharmacokinetics
583	DOC Document Add to Reading List Source URL: www.hc-sc.gc.ca Language: English - Date: 2013-06-24 11:39:21 Pharmaceutics Clinical research Pharmacokinetics Pharmaceuticals policy Drug Master File Excipient Dosage form Validation Bioequivalence Pharmaceutical industry Pharmaceutical sciences Pharmacology
584	Draft Comprehensive Summary - Bioequivalence (CS-BE) Add to Reading List Source URL: www.hc-sc.gc.ca Language: English - Date: 2013-07-12 14:25:33 Pharmaceutics Clinical research Bioequivalence Pharmaceutical industry Bioavailability Abbreviated New Drug Application Nitrazepam Clinical trial Methadone Pharmaceutical sciences Pharmacology Pharmacokinetics
585	Quality Overall Summary - Chemical Entities (Applications for Drug Identification Number Submission) (QOS-CE (DINA)) Add to Reading List Source URL: www.hc-sc.gc.ca Language: English - Date: 2013-07-12 14:26:08 Pharmacology Medicine Pharmaceuticals policy Validity Drug Master File Validation Excipient Dosage form Bioequivalence Pharmaceutical industry Pharmaceutical sciences Clinical research
586	DOC Document Add to Reading List Source URL: www.hc-sc.gc.ca Language: English - Date: 2013-06-24 11:39:21 Pharmacology Research Pharmaceuticals policy Validity Validation Excipient Drug Master File Dosage form Bioequivalence Pharmaceutical industry Pharmaceutical sciences Clinical research
587	Medical Officer Review of Minirin complete response to AE letter NDA#: [removed]S-000 Sponsor: Ferring Pharmaceuticals Inc. Drug Product: Minirin® (desmopressin acetate) Dosage Strength: 0.1 and 0.2mg tablets Add to Reading List Source URL: www.fda.gov Language: English Research Desmopressin Design of experiments Nocturnal enuresis Clinical trial Bioequivalence Medicine Clinical research Health
588	DRAFT AGENDA ( Draft version of[removed]) Add to Reading List Source URL: www.fda.gov Language: English - Date: 2001-03-06 02:54:15 Pharmacology Immunology Food and Drug Administration Allergology Immune system Center for Biologics Evaluation and Research Allergen Bioequivalence Biologic Medicine Biotechnology Pharmaceutical sciences
589	DRAFT AGENDA ( Draft version of[removed]FOOD AND DRUG ADMINISTRATION CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER) ALLERGENIC PRODUCTS ADVISORY COMMITTEE MEETING March 5, 2001 Add to Reading List Source URL: www.fda.gov Language: English - Date: 2001-03-06 02:54:15 Pharmacology Immunology Food and Drug Administration Allergology Immune system Center for Biologics Evaluation and Research Allergen Bioequivalence Biologic Medicine Biotechnology Pharmaceutical sciences
590	Pharmaceutical Quality of Aqueous Solutions Add to Reading List Source URL: www.hc-sc.gc.ca Language: English - Date: 2013-07-12 14:25:28 Clinical research Pharmaceuticals policy Quality Research Bioequivalence Abbreviated New Drug Application Regulatory requirement Specification Bioavailability Pharmacokinetics Pharmaceutical sciences Pharmacology

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