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IVIVC
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1	© World Health Organization WHO Technical Report Series, No. 937, 2006 Annex 7 Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish Add to Reading List Source URL: apps.who.int Language: English - Date: 2006-11-21 08:38:00 Pharmaceutics Clinical research Pharmaceutical industry Food and Drug Administration Bioequivalence Abbreviated New Drug Application Bioavailability Active ingredient IVIVC Pharmaceutical sciences Pharmacology Pharmacokinetics
2	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 Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutics Pharmaceutical industry Bioequivalence Clinical research IVIVC Bupropion Abbreviated New Drug Application Generic drug In vitro Pharmacology Pharmaceutical sciences Pharmacokinetics
3	Use and Limitations of In Vitro Dissolution Testing: Topic Introduction and Overview Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical industry Quality control Pharmaceutics Food and Drug Administration IVIVC Pharmacokinetics Bioequivalence Dissolution In vitro Pharmaceutical sciences Pharmacology Dissolution testing
4	Biopharmaceutics Risk of OrallyAdministered Products FY 2014 GDUFA Regulatory Science Initiatives Part 15 Public Meeting Silver Spring, MD James E. Polli and Tricia Ting Add to Reading List Source URL: www.fda.gov Language: English Chemistry Food and Drug Administration IVIVC Bioequivalence Pharmaceutical sciences Biopharmaceutics Classification System In vivo Lamotrigine Abbreviated New Drug Application Anticonvulsants Mood stabilizers Pharmacology
5	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 Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical industry Clinical research Pharmacology Food and Drug Administration Dissolution testing IVIVC Pharmaceutical sciences In vivo In vitro
6	What are clinically relevant dissolution specifications? Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences In vivo Bioavailability Pharmaceutical industry Dissolution testing Food and Drug Administration IVIVC Pharmacokinetics
7	What are clinically relevant dissolution specifications? Add to Reading List Source URL: www.fda.gov Language: English Clinical research Bioequivalence Pharmacokinetics In vivo Food and Drug Administration Dissolution testing IVIVC Pharmaceutical sciences Pharmacology Research
8	Generic Drug User Fee Amendments of 2012 Regulatory Science Initiatives: 4. QbD and 6. Anti-epileptic drugs 7. BCS James E. Polli Add to Reading List Source URL: www.fda.gov Language: English Mood stabilizers Clinical research Pharmacy Quality by Design IVIVC QBD Lamotrigine Bioequivalence Pharmaceutics Pharmaceutical sciences Pharmacology Anticonvulsants
9	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: Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Asthma Pharmacokinetics Respiratory therapy Inhaler IVIVC In vitro In vivo Bioequivalence Pharmacology Medicine Dosage forms
10	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 Add to Reading List Source URL: cran.r-project.org Language: English - Date: 2014-09-23 01:30:22 Scientific modelling Science Epistemology Knowledge Pharmacokinetics Pharmacology Pharmacy