Preclinical Development Handbook

A clear, straightforward resource to guide you through preclinical drug development Following this book's step-by-step guidance, you can successfully initiate and complete critical phases of preclinical drug development. The book serves as a basic, comprehensive reference to prioritizing and optimizing leads, dose formulation, ADME, pharmacokinetics, modeling, and regulations. This authoritative, easy-to-use resource covers all the issues that need to be considered and provides detailed instructions for current methods and techniques. Each chapter is written by one or more leading experts in the field. These authors, representing the many disciplines involved in preclinical toxicology screening and testing, give you the tools needed to apply an effective multidisciplinary approach. The editor has carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear. Among the key topics covered are: * Modeling and informatics in drug design * Bioanalytical chemistry * Absorption of drugs after oral administration * Transporter interactions in the ADME pathway of drugs * Metabolism kinetics * Mechanisms and consequences of drug-drug interactions Each chapter offers a full exploration of problems that may be encountered and their solutions. The authors also set forth the limitations of various methods and techniques used in determining the safety and efficacy of a drug during the preclinical stage. This publication should be readily accessible to all pharmaceutical scientists involved in preclinical testing, enabling them to perform and document preclinical safety tests to meet all FDA requirements before clinical trials may begin.

A clear, straightforward resource to guide you through preclinicaldrug developmentFollowing this book's step-by-step guidance, you can successfullyinitiate and complete critical phases of preclinical drugdevelopment. The book serves as a basic, comprehensive reference toprioritizing and optimizing leads, dose formulation, ADMEpharmacokinetics, modeling, and regulations. This authoritativeeasy-to-use resource covers all the issues that need to beconsidered and provides detailed instructions for current methodsand techniques.Each chapter is written by one or more leading experts in thefield. These authors, representing the many disciplines involved inpreclinical toxicology screening and testing, give you the toolsneeded to apply an effective multidisciplinary approach. The editorhas carefully reviewed all the chapters to ensure that each one isthorough, accurate, and clear.Among the key topics covered are:* Modeling and informatics in drug design* Bioanalytical chemistry* Absorption of drugs after oral administration* Transporter interactions in the ADME pathway of drugs* Metabolism kinetics* Mechanisms and consequences of drug-drug interactionsEach chapter offers a full exploration of problems that may beencountered and their solutions. The authors also set forth thelimitations of various methods and techniques used in determiningthe safety and efficacy of a drug during the preclinicalstage.This publication should be readily accessible to all pharmaceuticalscientists involved in preclinical testing, enabling them toperform and document preclinical safety tests to meet all FDArequirements before clinical trials may begin.