Pharmaceutical Stress Testing

Stress testing is the main tool that is used to predict stability problems,
7 E+ Y: m# h1 G6 |develop analytical methods, and identify degradation products/pathways.
1 W" o# K/ X, J7 E$ h' eSince there are no detailed regulatory guidelines that direct how stress testing
; t1 D# ^! `' m3 v# K0 [7 g7 [is to be done, nor has there ever been a text/reference book on the
subject, stress testing has evolved into an artful science that is highly dependent
/ a+ W" M& {$ Fon the experience of the company or the individuals directing the studies. This
: u5 Y/ K; j  q" m# r" i& Nbook 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
# ]* Q* u2 K7 h) ~. V2 c% Ztopics such as mass balance, photostability, oxidative susceptibility, and the
5 X& E/ ]3 F- j( K3 b3 Bchemistry of drug degradation are addressed in an objective, detailed scientific
manner, with ample references to relevant guidances and the scientific literature.
Compiling 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
complex. Thus, this book seeks to be a practical and scientific guide
which will, hopefully, stimulate new ideas and further development of the
science.
This undertaking is done with some trepidation, since I realize that discussion
of this topic could lead to attempts to formalize or standardize (i.e.,
" n1 Q$ p2 d7 ^regulatory standardization) an area of pharmaceutical science that relies on
2 K' q1 r$ u  q; x$ z3 f* p- {& Uscientific expertise and flexibility. Each new drug compound, formulation,
route of administration, delivery device, etc. has the potential to present
unique challenges and unanticipated problems, and should be approached
1 [) L+ b# k: Pwith such a mindset. The pharmaceutical researcher must be free to design
# g! s9 }4 P  A, x4 @0 aand develop new ways to predict and measure stability-related issues
through stress testing. Nonetheless, it is hoped that this book will provide
3 J. `+ E. b! \3 D2 ~/ ]. A7 r% qa useful and practical scientific guide that is a welcome addition to the
library of many pharmaceutical scientists. I am confident that the ‘‘artful
6 a% ?3 c$ F  G8 Oscience’’ of stress testing will evolve beyond what is represented in this book
% Q; d+ ?2 T) d# o5 ~* Gas other scientists further the science and fill in topics that are poorly covered
2 e% E6 @, x' k' E/ ?or missing.
7 {4 V2 Y4 k/ Z0 i5 ]; ?$ K- w
7 K6 `! n" l( J. V) I

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