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Simcyp Simulator
Results: 7

#	Item
1	Guidance for Industry Drug Metabolism/Drug Interaction Studies in the Drug Development Process: Studies In Vitro Department of Health and Human Services Add to Reading List Source URL: www.fda.gov Language: English Pharmacokinetics Metabolism Drug discovery Biochemistry Microsome Cytochrome P450 Pharmacogenetics Drug development Simcyp Simulator Pharmaceutical sciences Pharmacology Biology
2	Experimental Measurement and Computational Modeling of In Vivo Drug Dissolution for Accurate BA/BE Study and Prediction Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutics Bioavailability Absorption IVIVC Bioequivalence Dipyridamole Simcyp Simulator Biopharmaceutics Classification System Pharmacokinetics Pharmacology Pharmaceutical sciences
3	Figure 1. Metabolism-Based Drug-Drug Interaction Studies — Decision Tree Conduct In Vitro Metabolism and Drug-Drug Interaction Studies in Human Tissuesa - Phase I enzymes: CYP 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 3A, others Add to Reading List Source URL: www.fda.gov Language: English Biomolecules Catalysis Pharmacokinetics Metabolism Enzyme In vitro In vivo Cytochrome P450 Simcyp Simulator Chemistry Pharmaceutical sciences Pharmacology
4	Guidance for Industry Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling Add to Reading List Source URL: www.fda.gov Language: English - Date: 2003-05-29 13:23:10 Lactams Pharmacokinetics Nitrazepam Hepatotoxicity Simcyp Simulator Ezetimibe Chemistry Organic chemistry Medicine
5	Update of 2012 FDA Draft Guidance on Drug Interactions: Model-based Strategy to Integrate Knowledge and Quantify Effects Add to Reading List Source URL: www.fda.gov Language: English Biology Membrane biology Microsome Physiologically based pharmacokinetic modelling Cytochrome P450 Simcyp Simulator Pharmacokinetics Pharmacology Pharmaceutical sciences
6	Application of PBPK in Regulatory Review of Clinical Pharmacology Issues at FDA Add to Reading List Source URL: www.fda.gov Language: English Pharmacy Physiologically based pharmacokinetic modelling Toxicokinetics Toxicology ADME Simcyp Simulator Pharmaceutical sciences Pharmacokinetics Pharmacology
7	Predicting Transporter Drug-Drug Interaction Using PBPK: Impact of Variability in In Vitro Data Perspective Add to Reading List Source URL: www.fda.gov Language: English Chemistry Pharmacy Metabolism Physiologically based pharmacokinetic modelling Toxicokinetics Enzyme Microsome Didanosine Simcyp Simulator Pharmaceutical sciences Pharmacology Pharmacokinetics

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