Biopharmaceutics Classification System

Results: 35



#Item
11Medicinal 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
12Chemistry / Food and Drug Administration / IVIVC / Bioequivalence / Pharmaceutical sciences / Biopharmaceutics Classification System / In vivo / Lamotrigine / Abbreviated New Drug Application / Anticonvulsants / Mood stabilizers / Pharmacology

Biopharmaceutics Risk of OrallyAdministered Products FY 2014 GDUFA Regulatory Science Initiatives Part 15 Public Meeting Silver Spring, MD James E. Polli and Tricia Ting

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Source URL: www.fda.gov

Language: English
13Law / Gilead Sciences / Dissolution testing / Quality control / Bioequivalence / Biopharmaceutics Classification System / Emtricitabine / Generic drug / In vivo / Pharmaceutical industry / Pharmaceutical sciences / Pharmacology

Microsoft Word - Emtricitabine_cap_21500_RC8-05.doc

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Source URL: www.fda.gov

Language: English
14Solubility / Acid dissociation constant / Titration / PH / Biopharmaceutics Classification System / Chemistry / Equilibrium chemistry / Solutions

Microsoft Word - Discovery BCS Solubility data sheet.docx

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Source URL: tsrlinc.com

Language: English - Date: 2011-05-02 15:56:42
15Solubility / Acid dissociation constant / Titration / PH / Biopharmaceutics Classification System / Solubility equilibrium / Chemistry / Equilibrium chemistry / Solutions

Microsoft Word - GLP BCS Solubility data sheet.docx

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Source URL: tsrlinc.com

Language: English - Date: 2011-04-28 14:53:38
16Quality control / Solutions / Gastric acid / USP / Enzyme / Dissolution / Assay / Solubility / Biopharmaceutics Classification System / Chemistry / Dissolution testing / Pharmaceutical industry

Microsoft Word - Discovery BCS Dissolution data sheet.docx

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Source URL: tsrlinc.com

Language: English - Date: 2011-05-02 15:17:58
17Quality control / Pharmacology / USP / Gastric acid / Abbreviated New Drug Application / Enzyme / Aspirin / Biopharmaceutics Classification System / Chemistry / Pharmaceutical industry / Dissolution testing

Microsoft Word - GLP BCS Drug Product Dissolution data sheet.docx

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Source URL: tsrlinc.com

Language: English - Date: 2011-05-02 16:04:10
18Pharmacokinetics / Clinical research / Bioequivalence / Pharmacy / Generic drug / Bioavailability / Biopharmaceutics Classification System / Adverse effect / Pharmacovigilance / Pharmaceutical sciences / Pharmacology / Health

the sciences of similarity: the role of social science research in generic drug regulation Jeremy A. Greene, MD, PhD   Departments of Medicine and the History of Medicine

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Source URL: www.fda.gov

Language: English
19Pharmaceutical sciences / Biopharmaceutics Classification System / Clinical research / Medicinal chemistry / Phenols / Bioavailability / Bioequivalence / Regulatory requirement / Solubility / Pharmacology / Chemistry / Pharmacokinetics

Guidance Document: Biopharmaceutics Classification System Based Biowaiver

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Source URL: hc-sc.gc.ca

Language: English - Date: 2014-05-29 15:44:51
20Pharmacology / Biology / Biopharmaceutics Classification System / Pharmaceutical industry / ABC transporters / Caco-2 / P-glycoprotein / Bioequivalence / Bioavailability / Pharmaceutical sciences / Clinical research / Pharmacokinetics

Expanding BCS-Based Biowaivers Lisa Murray, M.S. Absorption Systems GDUFA Regulatory Science Initiatives May 16, 2014

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Source URL: www.fda.gov

Language: English
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