Kim Huynh-Ba – Handbook of Stability Testing in Pharmaceutical Development

Автор: Kim Huynh-Ba
Название книги: Handbook of Stability Testing in Pharmaceutical Development
Формат: PDF
Жанр: Медицина
Страницы: 390
Качество: Изначально компьютерное, E-book

This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Written by a group of international experts, the book presents a scientific understanding of regulations and balances methodologies and best practices.

In my professional career as a pharmaceutical scientist, I have been involved with
several aspects of the drug development process from pre-IND to commercialization
and, somehow, I usually found myself coming back to a stability-related issue. The
stability area seemed to draw my utmost interest because in my day-to-day work,
my opportunities involved more than one product, and none of the issues were the
same. Each situation posed challenges that usually required an exercise of judgment,
an understanding of regulations, a knowledge of science, a grasp of compliance, and
an appreciation of common practices.
Since early 2000, I have also been involved with several training opportunities and
I struggled to find good, concise, practical resources, one of which I could just hand
to a new scientist who wishes to gain a greater understanding of stability sciences.
In addition, I encountered the same questions posted over and over on different
stability best practices discussion forums.
As a book lover, I also have a good collection of technical books. Unfortunately,
most of the stability related volumes are outdated. Many of these materials
are theoretical and do not contain much practical information. I understand that
the pharmaceutical industry during this period is quite volatile, and guidelines are
changing rapidlywhile regulatory agencies are working closely with the pharmaceutical
industry to accommodate these changes; however, the fundamental information
continues to remain quite the same, just as current Good Manufacturing Practices
(cGMP) continue to be the standard industry practice. Therefore, I hoped to assemble
a practical handbook to fill this void.
Handbook of Stability Testing in Pharmaceutical Development is a product of
several dedicated stability scientists. Collectively, we have over 300 years of experience
working in all aspects of the pharmaceutical industry. This volume is intended
to bring together a comprehensive overview of a stability program coupled with
practical best practices. It can be used to serve the stability community as a handbook
to train new scientists who find themselves involved with stability sciences in
multidisciplinary functions. It can also be used in an academic setting so students
can gain more practical understanding of the pharmaceutical industry.It contains
essential information to guide best practices for development and management of a
compliant stability program.