IVIVC

Results: 18



#Item
1Pharmaceutics / Clinical research / Pharmaceutical industry / Food and Drug Administration / Bioequivalence / Abbreviated New Drug Application / Bioavailability / Active ingredient / IVIVC / Pharmaceutical sciences / Pharmacology / Pharmacokinetics

© World Health Organization WHO Technical Report Series, No. 937, 2006 Annex 7 Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish

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Source URL: apps.who.int

Language: English - Date: 2006-11-21 08:38:00
2Pharmaceutics / Pharmaceutical industry / Bioequivalence / Clinical research / IVIVC / Bupropion / Abbreviated New Drug Application / Generic drug / In vitro / Pharmacology / Pharmaceutical sciences / Pharmacokinetics

FY 2013 Awarded GDUFA Regulatory Research Contracts and Grants FY2014 Extension or Expansion Development of In Vivo Predictive Dissolution Method for Orally Inhaled Drug Products • Multiple Awards to: University of Bat

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Source URL: www.fda.gov

Language: English
3Pharmaceutical industry / Quality control / Pharmaceutics / Food and Drug Administration / IVIVC / Pharmacokinetics / Bioequivalence / Dissolution / In vitro / Pharmaceutical sciences / Pharmacology / Dissolution testing

Use and Limitations of In Vitro Dissolution Testing: Topic Introduction and Overview

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Source URL: www.fda.gov

Language: English
4Chemistry / 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
5Pharmaceutical industry / Clinical research / Pharmacology / Food and Drug Administration / Dissolution testing / IVIVC / Pharmaceutical sciences / In vivo / In vitro

Biorelevant In-Vitro Release Testing of NonOral Dosage Forms – FDA Perspectives Tapash Ghosh, Ph.D Team Leader, Biopharmaceutics, ONDQA, FDA Annual AAPS, San Antonio, Texas November 11, 2013 Disclaimer: The contents of

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Source URL: www.fda.gov

Language: English
6Pharmaceutical sciences / In vivo / Bioavailability / Pharmaceutical industry / Dissolution testing / Food and Drug Administration / IVIVC / Pharmacokinetics

What are clinically relevant dissolution specifications?

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Source URL: www.fda.gov

Language: English
7Clinical research / Bioequivalence / Pharmacokinetics / In vivo / Food and Drug Administration / Dissolution testing / IVIVC / Pharmaceutical sciences / Pharmacology / Research

What are clinically relevant dissolution specifications?

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Source URL: www.fda.gov

Language: English
8Mood stabilizers / Clinical research / Pharmacy / Quality by Design / IVIVC / QBD / Lamotrigine / Bioequivalence / Pharmaceutics / Pharmaceutical sciences / Pharmacology / Anticonvulsants

Generic Drug User Fee Amendments of 2012 Regulatory Science Initiatives: 4. QbD and 6. Anti-epileptic drugs 7. BCS James E. Polli

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Source URL: www.fda.gov

Language: English
9Pharmaceutical 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
10Scientific modelling / Science / Epistemology / Knowledge / Pharmacokinetics / Pharmacology / Pharmacy

Package ‘ivivc’ September 23, 2014 Version[removed]Date[removed]Title A data analysis tool for in vitro-in vivo correlation (IVIVC) Author Hsin-ya Lee, Yung-jin Lee

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Source URL: cran.r-project.org

Language: English - Date: 2014-09-23 01:30:22
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