Bioequivalence

Results: 910



#Item
531Pharmaceutical sciences / Asthma / Pharmacokinetics / Respiratory therapy / Inhaler / IVIVC / In vitro / In vivo / Bioequivalence / Pharmacology / Medicine / Dosage forms

In Vitro & CFD Bioequivalence Testing for Orally Inhaled Drug Products Peter R Byron, Michael Hindle and Worth Longest Schools of Pharmacy and Engineering, Virginia Commonwealth University, Richmond, VA Research support:

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Source URL: www.fda.gov

Language: English
532Medicine / Clinical research / Generic drug / Pharmaceuticals policy / Public domain / Food and Drug Administration / Bioequivalence / Bupropion / Package insert / Pharmaceutical sciences / Pharmacology / Pharmaceutical industry

A Need for Greater Transparency for Generic Drugs (Slides accompanying oral presentation)

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Source URL: www.fda.gov

Language: English
533Medicine / Bioequivalence / Clinical research / Abbreviated New Drug Application / Bioavailability / Food and Drug Administration / Epilepsy / Generic drug / Pharmaceutical sciences / Pharmacokinetics / Pharmacology

GDUFA Recommendations by the EQUIGEN steering committee

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Source URL: www.fda.gov

Language: English
534In vitro / Bioequivalence / Nasal administration / In vivo / Bioavailability / Pharmacology / Pharmaceutical sciences / Pharmacokinetics

Bioequivalence of Inhalation Drugs

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Source URL: www.fda.gov

Language: English
535Pharmaceuticals policy / Clinical research / Food and Drug Administration / Therapeutics / United States Public Health Service / Generic drug / Abbreviated New Drug Application / Bioequivalence / Good manufacturing practice / Pharmaceutical sciences / Pharmacology / Pharmaceutical industry

U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may

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Source URL: www.fda.gov

Language: English
536Chemistry / Macrolides / Organ transplants / Tacrolimus / Sirolimus / Bioequivalence / Generic drug / Abbreviated New Drug Application / Mycophenolic acid / Medicine / Immunosuppressants / Pharmacology

American Society of Transplantation Open Public Hearing Comments Rita Alloway, PharmD, FCCP American Society of Transplantation Board Member Research Professor of Medicine

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Source URL: www.fda.gov

Language: English
537

Liste des membres - Groupe consultatif scientifique sur les exigences en matière de bioéquivalence pour les formes pharmaceutiques à libérations modifiée

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Source URL: www.hc-sc.gc.ca

Language: French - Date: 2013-06-24 11:52:30
    538Pharmaceutical 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
    539Pharmaceutical sciences / Education / Faculty of Medicine – University of Manitoba / Academia / D. George Wyse / Medical school / Pharmacy school / Clinical pharmacology

    Membership list - Scientific Advisory Panel on Bioequivalence Requirements for Modified-Release Dosage Forms

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    Source URL: www.hc-sc.gc.ca

    Language: English - Date: 2013-06-24 11:52:30
    540Clinical research / Clinical pharmacology / Food and Drug Administration / Pharmaceutical industry / Bioequivalence / Abbreviated New Drug Application / Center for Drug Evaluation and Research / Drug discovery / Pharmaceutical sciences / Pharmacology / Research

    Regulatory Options: NDA Process

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    Source URL: www.fda.gov

    Language: English
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