Bioequivalence

Results: 910



#Item
851Research / Pharmacology / Food and Drug Administration / Drug safety / Pharmaceuticals policy / Abbreviated New Drug Application / New Drug Application / Bioequivalence / Validation / Clinical research / Pharmaceutical industry / Pharmaceutical sciences

Guidance for Industry Providing Regulatory Submissions in Electronic Format — ANDAs U.S. Department of Health and Human Services Food and Drug Administration

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Source URL: www.fda.gov

Language: English
852Food and Drug Administration / Implants / Clinical pharmacology / United States Public Health Service / Form FDA 483 / Good Laboratory Practice / Bioequivalence / Pharmaceutical sciences / Medicine / Pharmacology

DEPARTMENT OF J3EALTH & HUMAN SERVIW WARNING LETTER Public Health Service

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Source URL: www.fda.gov

Language: English
853Pharmaceutics / Pharmaceutical industry / Clinical research / Pharmaceuticals policy / Bioequivalence / Biopharmaceutics Classification System / Abbreviated New Drug Application / Food and Drug Administration / Solubility / Pharmaceutical sciences / Pharmacology / Pharmacokinetics

Guidance for Industry #171 - Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles, February 16, 2006

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Source URL: www.fda.gov

Language: English
854Pharmacology / Pharmaceutical sciences / Pharmaceuticals policy / Abbreviated New Drug Application / Research / Generic drug / Bioequivalence / New Drug Application / Center for Drug Evaluation and Research / Pharmaceutical industry / Food and Drug Administration / Clinical research

MANUAL OF POLICIES AND PROCEDURES

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Source URL: www.fda.gov

Language: English
855Pharmaceutical industry / Research / Pharmacy / Pharmaceuticals policy / Generic drug / Clinical trial / Alternative medicine / Bioequivalence / Efficacy / Pharmaceutical sciences / Pharmacology / Clinical research

Subject: Public Consultation on PAES Delegated Act on Post-Authorisation Efficacy Studies Content of the opinion: Over several years, the introduction of innovative medicines has led to significant

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Source URL: ec.europa.eu

Language: English - Date: 2013-10-09 09:30:26
856Food and Drug Administration / Clinical research / Pharmacy / Center for Drug Evaluation and Research / Generic drug / Bioequivalence / Abbreviated New Drug Application / Drug development / Drug discovery / Pharmaceutical sciences / Pharmacology / Pharmaceutical industry

CDER: Overview of Pre- and Post-Market Programs

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Source URL: www.fda.gov

Language: English
857Dosage forms / Asthma / Pharmaceutical industry / Clinical research / Respiratory therapy / Metered-dose inhaler / Bioequivalence / Food and Drug Administration / Abbreviated New Drug Application / Medicine / Pharmacology / Pharmaceutical sciences

Next Breath GENERIC PMDI PRODUCT DEVELOPMENT FOR THE US: KEY CONSIDERATIONS In this technical paper, Badre Hammond, Associate Director, Business Development,

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Source URL: www.ondrugdelivery.com

Language: English - Date: 2014-06-19 06:32:31
858Computational neuroscience / Respiratory therapy / Chronic lower respiratory diseases / Asthma / Pharmaceutical industry / Bioequivalence / Artificial neural network / Inhalable insulin / Inhaler / Medicine / Pharmacology / Pulmonology

Figure 1 Excel graphs.xlsx

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Source URL: www.ondrugdelivery.com

Language: English - Date: 2014-06-19 06:32:15
859Pharmaceutical industry / Clinical research / Pharmacokinetics / Pharmaceuticals policy / Food and Drug Administration / Bioequivalence / Generic drug / Dissolution testing / Abbreviated New Drug Application / Pharmaceutical sciences / Pharmacology / Medicine

Center For Drug Evaluation and Research List of Guidance Documents

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Source URL: www.fda.gov

Language: English
860Food and Drug Administration / Drug safety / Clinical research / Pharmaceutical industry / Abbreviated New Drug Application / Bioequivalence / Investigational New Drug / Center for Drug Evaluation and Research / New Drug Application / Pharmaceutical sciences / Pharmacology / Medicine

Microsoft Word - Guidance Agenda 2012_080712.doc

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Source URL: www.fda.gov

Language: English
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