标题: Pharmaceutical Stress Testing [打印本页] 作者: lookspace 时间: 2014-8-1 08:43 AM 标题: Pharmaceutical Stress Testing Stress testing is the main tool that is used to predict stability problems, $ ?; S3 d7 o. o" l: I- \develop analytical methods, and identify degradation products/pathways.0 C1 [. L" m; X! I0 P. ]
Since there are no detailed regulatory guidelines that direct how stress testing5 N1 ?. I# J7 J |0 J$ \5 h8 B. p
is to be done, nor has there ever been a text/reference book on the0 E2 q O/ Y/ S. ]: \. o
subject, stress testing has evolved into an artful science that is highly dependent & P" M" Z& f5 f" c1 N+ Kon the experience of the company or the individuals directing the studies. This : }& i& z9 q2 }: m9 [+ p3 \- _* obook provides readers with a single source reference that benchmarks the, f0 ~) p; B8 j$ p
current best practices of experienced pharmaceutical scientists/researchers.8 V; N6 X; u" p' ]% ^3 k& M0 C
Questions like ‘‘How hot, how long, what conditions are appropriate?’’ and1 W! S" I6 v6 h5 d
topics such as mass balance, photostability, oxidative susceptibility, and the0 K h- O- A8 C l, E( c* t
chemistry of drug degradation are addressed in an objective, detailed scientific & D0 t9 w" @+ x. t6 Lmanner, with ample references to relevant guidances and the scientific literature.; y9 g% F. Y' N
Compiling a book to be used as a scientific reference for the topic of! \9 a4 Y9 I" C! v
pharmaceutical stress testing was a daunting task. Stress testing, as it relates 5 S! T+ z: \! u) b0 C; \to traditional small molecule pharmaceuticals, is very broad and scientifically7 z8 j$ ?- L l4 L$ l( g
complex. Thus, this book seeks to be a practical and scientific guide7 B0 C6 [$ [ t0 q- w1 q
which will, hopefully, stimulate new ideas and further development of the: U8 _4 \; w5 i8 s! G9 e
science. 9 ~0 h4 C. F% t/ eThis undertaking is done with some trepidation, since I realize that discussion ; B2 k6 l R% ~% bof this topic could lead to attempts to formalize or standardize (i.e.,# m' f- C3 R& m6 g3 H/ M) n4 Q( W: I
regulatory standardization) an area of pharmaceutical science that relies on* `0 F5 d1 v6 F" Y7 e5 T& s0 p
scientific expertise and flexibility. Each new drug compound, formulation,# R) O2 z2 @$ ]
route of administration, delivery device, etc. has the potential to present2 _3 l, P% o: Y& c$ h
unique challenges and unanticipated problems, and should be approached5 c7 Y4 c# k) t
with such a mindset. The pharmaceutical researcher must be free to design ; o8 a Z- N4 o2 t: _and develop new ways to predict and measure stability-related issues8 i( d5 \; t- f6 ~5 K. Q
through stress testing. Nonetheless, it is hoped that this book will provide% X$ f4 E! K7 o" }& U
a useful and practical scientific guide that is a welcome addition to the 6 i9 a# d; x/ B0 l: ~library of many pharmaceutical scientists. I am confident that the ‘‘artful $ K/ \; {% e4 ^. C3 }science’’ of stress testing will evolve beyond what is represented in this book ( Y) D# ?7 m* w, D: tas other scientists further the science and fill in topics that are poorly covered2 h$ G8 ]) W2 z8 n, x
or missing.8 Y" {$ B' X G6 H9 R7 o& J
