The recent International Conference on Harmonisation (ICH) revisions of regulatory requirements for quality, nonclinical, and clinical pharmaceutical product registration are the focus of this timely update.
This cutting-edge resource includes the major headings in the modular structure of the Common Technical Document (CTD), which is now the agreed format for product information submission. The format, specification, and technical requirements of the e-CTD, the electronic version of CTD, are also thoroughly discussed.
The book is organized into six highly practical segments:
This text is a must-have for those in the pharmaceutical industry determining regulatory requirements for the major world markets in Europe, the US, Canada, and Japan.
Supplying insight from international experts, this guide
Discusses formulation for poorly soluble drugs Presents biological requirements for nanotherapeutic applications Demonstrates the role of nanobiotechnology in the development of nanomedicine Documents recent advances in nanoparticulate technology—including electrospining, formation of microcrystals, and production of liquid crystalline phases Examines the technology of metallic nanoparticles
Tricky concepts are illustrated and explained with clarity and precision, as The Human Brain Book looks at how the brain sends messages to the rest of the body, how we think and feel, how we perform unconscious actions (for example, breathing), explores the nature of genius, asks why we behave the way we do, explains how we see and hear things, and how and why we dream. Physical and psychological disorders affecting the brain and nervous system are clearly illustrated and summarized in easy-to-understand terms.