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pharmacokinetics
Results: 1088

#	Item
941	Guideline for Industry Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies Add to Reading List Source URL: www.fda.gov Language: English Toxicology Medicine Medicinal chemistry Toxicokinetics Toxicity Aspirin Bioavailability Pharmacology Pharmaceutical sciences Pharmacokinetics
942	Clinical Pharmacology and Biopharmaceutics Summary _______________________________________________________________________ NDAs: [removed]Serial # SE8-018 Sponsor: GlaxoSmithKline. Add to Reading List Source URL: www.fda.gov Language: English Asthma Respiratory therapy Bioavailability Pharmacometrics Pharmaceutical sciences Pharmacokinetics Pharmacology
943	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
944	Guideline for Industry Dose-Response Information to Support Drug Registration ICH-E4 Add to Reading List Source URL: www.fda.gov Language: English Toxicology Clinical trials Pharmacokinetics Dose-response relationship Methadone Dose-ranging study Nitrazepam Phases of clinical research Maintenance dose Chemistry Pharmacology Pharmaceutical sciences
945	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
946	Guidance for Industry Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product DRAFT GUIDANCE This guidance document is being distributed for comment purposes only.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 Pharmaceutical industry Food and Drug Administration Biotechnology Biosimilar Biologic Validation Pharmacokinetics New Drug Application Pharmaceutical sciences Pharmacology Medicine
947	Guidance for Industry Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System Add to Reading List Source URL: www.fda.gov Language: English Medicinal chemistry Pharmaceutical industry Clinical research Biopharmaceutics Classification System Bioavailability Dissolution testing Absorption Bioequivalence Drug discovery Pharmaceutical sciences Pharmacology Pharmacokinetics
948	N21-038S022; S021 Dexmedetomidine Clinpharm BPCA Add to Reading List Source URL: www.fda.gov Language: English Anesthesia Hoffmann-La Roche Midazolam Organofluorides Pharmacometrics Pharmacokinetics Sedation Hospira Pharmacology Pharmaceutical sciences Medicine
949	CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW NDA[removed]UPDATED Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Pharmacokinetics Clofarabine Organofluorides Purines Acute myeloid leukemia Clinical pharmacology Bioavailability Pharmaceutical sciences Organochlorides Chemistry
950	Duloxetine 21-427S041 Clinpharm BPCA Add to Reading List Source URL: www.fda.gov Language: English Selective serotonin reuptake inhibitors Organofluorides Serotonin-norepinephrine reuptake inhibitors Amines Duloxetine Fluoxetine Paroxetine Fibromyalgia Pharmacokinetics Chemistry Organic chemistry Eli Lilly and Company

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