Preclinical Development Handbook / Pharmaceutical Development Bd.1 (PDF)

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.