As a guide for pharmaceutical professionals to the issues and practices of drug discovery toxicology, this book integrates and reviews the strategy and application of tools and methods at each step of the drug discovery process. • Guides researchers as to what drug safety experiments are both practical and useful • Covers a variety of key topics – safety lead optimization, in vitro-in vivo translation, organ toxicology, ADME, animal models, biomarkers, and –omics tools • Describes what experiments are possible and useful and offers a view into the future, indicating key areas to watch for new predictive methods • Features contributions from firsthand industry experience, giving readers insight into the strategy and execution of predictive toxicology practices
[11] Dietert RR, Zelikoff JT. Pediatric immune dysfunction and health risks following early-life immune insult. Curr Pediatr Rev 2009;5:36–51. [12] Chen M, Zhang L. Epigenetic mechanisms in developmental programming of adult disease.
This is an essential and practical resource for all toxicologists involved in nonclinical testing in industry, academic, and regulatory settings.
TABLE 28.3 ICH Final and Draft Guidelines (Safety, Selected Multidisciplinary)dcont'd Category Title Type Date ... a more recent revision to the guideline for the activity is available it will be discussed in the study activity section, ...
This book describes, with references to key source materials, the background to, and conduct of, the principal nonclinical studies that are central to drug development.
This book will be a key resource for drug developers, medicinal chemists and toxicologists, among others.Sections shine a particular focus on mechanisms of action, various principles in pharmacokinetics and pharmacodynamics terms, and ...
This book brings together a collection of state-of-the-art chapters, written by experts in the drug safety field.
This book describes the processes that are involved in the development of new drugs. The authors discuss the history, role of natural products and concept of receptor interactions with regard to the initial stages of drug discovery.
The bleeding time of the mesenteric blood vessels is observed through a microscope at a magnification of 40 ×. ... Br J Haematol 50:317–325 I.M.4.3 Template Bleeding Time Method PURPOSE AND RATIONALE The template bleeding time method is ...
These preclinical methods are described in the second volume „Safety and Pharmacokinetic Assays". Only then are first studies in human beings allowed. Special rules are established for Phase I studies.
The contributors to this volume: Cover drug transporters, cytochrome P-450 and drug-drug interactions, plasma protein binding, stability, drug formulation, preclinical safety assessment, toxicology, and toxicokinetics Address developability ...