This book contains an overview of the scientific and regulatory requirements for stability testing including the draft of the harmonised guideline for the stability testing in the EC, Japan and the USA. Therefore it will be possible to carry out stability testing in the most efficient way. This book may be of interest to scientists in the field of drug development in pharmaceutical industries, …
The present series is geared to the needs of the scientist of administrator in the pharmaceutical industry or allied fields wishing to gain additional knowledge of the quality assurance function. These volumes should also prove useful to those who are specialists in one aspect of quality assurance, but have not had the opportunity to deal in depth with the other important areas of this broad fu…
Combining basic theory, industrial practice and regulatory aspects in an original overview of pharmaceutical stability, this indispensable reference/text takes the reader from stability principles of the drug in dissolved, dispersed, and solid states through data analysis of the packaged drugs stability
Provides a sound theoretical basis for understanding chemical kinetics and its uses in studying drug stability. Treats the calculations, approximations, and estimates that are useful to the pharmacist in professional practice, and presents a collection of selected drug-stability data from the pharmaceutical literature. This Handbook makes accessible to the pharmacist much of the information nec…