pharmacokinetics

Results: 1088



#Item
931Pharmacy / Pharmacokinetics / Evaluation methods / Pharmaceutical industry / Pharmacodynamics / Food and Drug Administration / Sampling / Statistics / Clinical trial / Pharmaceutical sciences / Pharmacology / Science

Guidance for Industry Population Pharmacokinetics U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER)

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Source URL: www.fda.gov

Language: English
932Purines / 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
933Bioequivalence / Pharmacokinetics / Generic drug / Abbreviated New Drug Application / Food and Drug Administration / Structured Product Labeling / Pharmaceutical industry / Pharmaceutical sciences / Pharmacology / Clinical research

Generic Drug User Fee Amendment (GDUFA) SPL Industry Technical Specification Information Electronic Self‐Identification of Generic Drug Facilities or Sites

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Source URL: www.fda.gov

Language: English
934Pharmacy / Drug discovery / Heparins / Sulfonamides / Pharmacodynamics / Pharmacokinetics / Alosetron / Dofetilide / 5-HT3 antagonist / Pharmaceutical sciences / Pharmacology / Chemistry

The Science of Sex and Gender in Human health – PK-PD applications or case studies

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Source URL: www.fda.gov

Language: English
935Pharmacokinetics / 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
936Pharmaceutical industry / Pharmacokinetics / Clinical research / Drug safety / Bioequivalence / Abbreviated New Drug Application / Food and Drug Administration / Dissolution testing / New Drug Application / Pharmaceutical sciences / Pharmacology / Pharmaceutics

Microsoft Word - 10472dft.doc

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Source URL: www.fda.gov

Language: English
937Pharmaceutical industry / Dissolution testing / Quality control / Pharmacokinetics / IVIVC / Bioequivalence / In vitro / Abbreviated New Drug Application / Food and Drug Administration / Pharmaceutical sciences / Pharmacology / Pharmaceutics

Guidance for Industry Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations

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Source URL: www.fda.gov

Language: English
938Pharmacokinetics / 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
939Pharmaceutics / Clinical research / Dosage forms / Pharmacokinetics / Dissolution testing / Bioequivalence / Food and Drug Administration / Excipient / Generic drug / Pharmaceutical sciences / Pharmaceutical industry / Pharmacology

Guidance for Industry Immediate Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls, In

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Source URL: www.fda.gov

Language: English
940Prodrugs / Pharmacokinetics / Irinotecan / Lactones / Piperidines / Carboplatin / Chemistry / Pharmacology / Lactams

C:aaplatinB ReviewnicalPharmacologySummary_recommendions.doc

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Source URL: www.fda.gov

Language: English
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