Translational Admet for Drug Therapy - Principles, Methods, and Pharmaceutical Applications

Informationen zum Autor Souzan B. Yanni, PhD, is Founder and President of DMPK Consultants, Inc., which leads ADME/PK in support of preclinical and clinical investigations for of pharmaceutical and biotech companies.  She has over 20 years of hands-on leadership experience in planning, executing, and overseeing drug discovery and early development for therapeutic programs with national and international pharmaceutical companies, biotech groups, and CROs. Dr. Yanni possesses a PhD in Pharmaceutical Sciences, MS in Biochemistry, and BS in Chemistry. She is the author of several peer-reviewed articles, review articles, and book chapters on ADMET/PK as well as an external reviewer / editor for other journals. Klappentext Serving as a practical handbook about ADMET for drug therapy, this book presents effective technologies, methods, applications, data interpretation, and decision-making tactics for pharmaceutical and preclinical scientists. Chapters cover case studies and in vivo, in vitro, and computational tools for drug discovery and development, with new translational approaches to clinical drug investigations in various human populations.* Illustrates ADME properties, from bedside to bench and bench to bedside, for the design of safe and effective medicine in human populations* Provides examples that demonstrate the integration of in vitro, in vivo, and in silico data to address human PKPD and TKTD and help determine the proper therapeutic dosage* Presents successful tools for evaluating drugs and covers current translational ADMET with regulatory guidelines* Offers a hands-on manual for researchers and scientists to design and execute in vitro, in silico, preclinical, and clinical studies* Includes discussion of IND / NDA filing and drug labeling to support drug registration and approval Zusammenfassung Serving as a practical handbook about ADMET for drug therapy, this book presents effective technologies, methods, applications, data interpretation, and decision-making tactics for pharmaceutical and preclinical scientists. Inhaltsverzeichnis Contributors xv Preface xvii Acknowledgement xxi 1 Translational Concept and Determination of Drug Absorption 1 1.1 Drug Absorption, Mechanism, and its Impact on Drug Bioavailability, Drug Disposition, and Drug Safety 1 1.1.1 Drug Absorption and Oral Bioavailability 2 1.1.2 Contribution of Intestinal Drug Transporters and Drug-Metabolizing Enzymes on Extent of Absorption and Mechanism 4 1.1.2.1 Intestinal Transporters 4 1.1.2.2 The Impact of Intestinal Metabolism on Drug Absorption 8 1.2 Effect of Physiochemical Property-Related Factors on Drug Absorption 9 1.2.1 Lipophilicity, Solubility and Dissolution, and Permeability 9 1.2.1.1 Lipophilicity 9 1.2.1.2 Solubility 11 1.2.1.3 Permeability 12 1.3 Effect of GI-Physiological Factors and Patient Condition on Drug Absorption 14 1.3.1 Effect of pH, Intestinal Surface Area, Gastric Emptying, Transient Time, and Bile Acid 14 1.3.1.1 Effect of pH and Surface Area 14 1.3.1.2 Effect of Gastric Emptying and Intestinal Transit Time 17 1.3.1.3 Effect of Bile and Bile Salts 17 1.3.2 Impact of Age and Disease State on Drug Absorption 18 1.3.2.1 Drug Absorption in Pediatric Populations 18 1.3.2.2 Drug Absorption in Disease State 19 1.4 Effect of Food and Formulation on Drug Absorption 20 1.4.1 Effect of Food 20 1.4.2 Formulation Effect 21 1.4.3 The BCS in Relation to Intestinal Absorption 22 1.5 Translational Approaches to Determine Drug Absorption in Clinical Studies 24 1.5.1 Cellular Intestinal Model 24 1.5.2 In Vitro Artificial Membrane 24 1.5.3 Non-In Vitro Models: In Situ and In Vivo 25 References 27 2 Distribution: Principle, Methods, and Applications 37 2.1 I...

Product details

• Authors: Yanni, SB Yanni, Souzan Yanni, Souzan B Yanni, Souzan B. Yanni
• Publisher: Wiley, John and Sons Ltd
• Languages: English
• Product format: Hardback
• Released: 07.10.2015
• EAN: 9781118838273
• ISBN: 978-1-118-83827-3
• No. of pages: 352
• Subject: Natural sciences, medicine, IT, technology > Chemistry > Miscellaneous