Pharmaceutical Stress Testing

Stress testing is the main tool that is used to predict stability problems,
* ?0 t& [8 j, A2 y& i7 \. }3 Odevelop analytical methods, and identify degradation products/pathways.
9 s/ Z( q5 ?6 y$ n. S" m" N( T9 ~' YSince there are no detailed regulatory guidelines that direct how stress testing
3 n0 ^6 x1 l. [7 L- Lis to be done, nor has there ever been a text/reference book on the
+ R8 U5 |7 F0 p+ f: V* Y7 gsubject, stress testing has evolved into an artful science that is highly dependent
( x6 I( F$ R3 g2 r6 w& e- won the experience of the company or the individuals directing the studies. This
book provides readers with a single source reference that benchmarks the
current best practices of experienced pharmaceutical scientists/researchers.
Questions like ‘‘How hot, how long, what conditions are appropriate?’’ and
topics such as mass balance, photostability, oxidative susceptibility, and the
! B  X4 p' f8 B$ i2 ]chemistry of drug degradation are addressed in an objective, detailed scientific
manner, with ample references to relevant guidances and the scientific literature.
3 P2 N( a* ^' l1 e! q5 `2 N$ S3 gCompiling a book to be used as a scientific reference for the topic of
pharmaceutical stress testing was a daunting task. Stress testing, as it relates
to traditional small molecule pharmaceuticals, is very broad and scientifically
7 z. i) `, s6 ~* m% `7 Mcomplex. Thus, this book seeks to be a practical and scientific guide
which will, hopefully, stimulate new ideas and further development of the
science.
! `6 ]6 b- H% `5 }# AThis undertaking is done with some trepidation, since I realize that discussion
of this topic could lead to attempts to formalize or standardize (i.e.,
regulatory standardization) an area of pharmaceutical science that relies on
( E% H6 B; _1 i' ^" j5 x1 _scientific expertise and flexibility. Each new drug compound, formulation,
' C2 {5 g5 Z! q# h8 ]route of administration, delivery device, etc. has the potential to present
unique challenges and unanticipated problems, and should be approached
with such a mindset. The pharmaceutical researcher must be free to design
and develop new ways to predict and measure stability-related issues
8 d' o, X- N( `# i( ~through stress testing. Nonetheless, it is hoped that this book will provide
a useful and practical scientific guide that is a welcome addition to the
: W" B( j1 X* F, f, ^( ^0 ylibrary of many pharmaceutical scientists. I am confident that the ‘‘artful
; [% g4 l; Z4 H; F6 h# tscience’’ of stress testing will evolve beyond what is represented in this book
7 X; p1 Z2 f1 r( Ias other scientists further the science and fill in topics that are poorly covered
or missing.

呜呜呜呜  ，英语烂的我只有哭了哈

楼主高大上。刚看前俩词我以为是个测试，读完发现是本书，貌似还不粗的书，我理解的对吗？

看了我头好大

顶一下 只是英文不太好