Bioavailability

Results: 642



#Item
581Purines / Organic chemistry / Adefovir / Hepatitis B / Bioequivalence / Bioavailability / Nitazoxanide / Chemistry / Pharmacology / Pharmacokinetics

N21449S011 Pediatric Clinpharm Review

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Source URL: www.fda.gov

Language: English
582Pharmacokinetics / Lactams / Aging / Geriatrics / Life extension / Nitrazepam / Organochlorides / Bioavailability / Geriatric anesthesia / Pharmacology / Pharmaceutical sciences / Chemistry

Guideline for Industry Studies in Support of Special Populations: Geriatrics ICH-E7

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Source URL: www.fda.gov

Language: English
583Pharmacokinetics / Clinical research / Toxicology / Design of experiments / Dose-response relationship / Bioequivalence / Bioavailability / Methadone / Clinical trial / Pharmaceutical sciences / Pharmacology / Medicine

Guidance for Industry Exposure-Response Relationships — Study Design, Data Analysis, and Regulatory Applications U.S. Department of Health and Human Services

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Source URL: www.fda.gov

Language: English
584Toxicology / Medicine / Medicinal chemistry / Toxicokinetics / Toxicity / Aspirin / Bioavailability / Pharmacology / Pharmaceutical sciences / Pharmacokinetics

Guideline for Industry Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies

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Source URL: www.fda.gov

Language: English
585Asthma / Respiratory therapy / Bioavailability / Pharmacometrics / Pharmaceutical sciences / Pharmacokinetics / Pharmacology

Clinical Pharmacology and Biopharmaceutics Summary _______________________________________________________________________ NDAs: [removed]Serial # SE8-018 Sponsor: GlaxoSmithKline.

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Source URL: www.fda.gov

Language: English
586Medicinal chemistry / Pharmaceutical industry / Clinical research / Biopharmaceutics Classification System / Bioavailability / Dissolution testing / Absorption / Bioequivalence / Drug discovery / Pharmaceutical sciences / Pharmacology / Pharmacokinetics

Guidance for Industry Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System

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Source URL: www.fda.gov

Language: English
587Pharmacology / Pharmacokinetics / Clofarabine / Organofluorides / Purines / Acute myeloid leukemia / Clinical pharmacology / Bioavailability / Pharmaceutical sciences / Organochlorides / Chemistry

CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW NDA[removed]UPDATED

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Source URL: www.fda.gov

Language: English
588Pharmaceutics / Pharmaceutical industry / Clinical research / Pharmaceuticals policy / Bioequivalence / Bioavailability / Abbreviated New Drug Application / Dissolution testing / Generic drug / Pharmaceutical sciences / Pharmacology / Pharmacokinetics

Guidance for Industry Bioavailability and Bioequivalence Studies for Orally Administered Drug Products — General Considerations U.S. Department of Health and Human Services

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Source URL: www.fda.gov

Language: English
589ACE inhibitors / Chemistry / Lactams / Enantiopure drugs / Benazepril / prodrugs / Bioequivalence / Bioavailability / Pharmacology / Pharmacokinetics / Pharmaceutical sciences

19851se5-028 BPCA Lotensin Review

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Source URL: www.fda.gov

Language: English
590Nephrology / Gadolinium / Gadopentetic acid / Gadoteric acid / Bioavailability / Chemistry / Matter / Nephrogenic systemic fibrosis

[removed]Gadoterate Clinpharm PREA

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Source URL: www.fda.gov

Language: English
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