Pharmaceutical Stress Testing

Stress testing is the main tool that is used to predict stability problems,
# C9 @4 F* b% }5 L# Y3 udevelop analytical methods, and identify degradation products/pathways.
, k# ?: p! B6 }7 Y) z( v3 JSince there are no detailed regulatory guidelines that direct how stress testing
! m% d" K; C% @+ Y: J0 }( Ais 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
on the experience of the company or the individuals directing the studies. This
: _8 B& x# D0 v& r( J+ {book provides readers with a single source reference that benchmarks the
current best practices of experienced pharmaceutical scientists/researchers.
7 L) {5 j( m+ ~$ v7 H: zQuestions like ‘‘How hot, how long, what conditions are appropriate?’’ and
# O7 c, m! Q# Q: E+ y) }2 ntopics such as mass balance, photostability, oxidative susceptibility, and the
chemistry of drug degradation are addressed in an objective, detailed scientific
manner, with ample references to relevant guidances and the scientific literature.
- F1 P4 N' k4 c$ f) l! r% eCompiling a book to be used as a scientific reference for the topic of
7 W  i$ I$ y( A" W* }) O* Npharmaceutical stress testing was a daunting task. Stress testing, as it relates
& D( }' z* o, s1 c, o/ k/ D0 i6 k$ ^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
* Q7 m% B5 _$ m3 o4 a+ A$ S2 ?$ ]# Bscience.
) j. d4 O# f6 @! {( C; k- ~* F: o: \This undertaking is done with some trepidation, since I realize that discussion
$ n7 Y1 E. ~, b) Vof this topic could lead to attempts to formalize or standardize (i.e.,
regulatory standardization) an area of pharmaceutical science that relies on
8 A6 R) u8 Z& v8 ?5 iscientific expertise and flexibility. Each new drug compound, formulation,
. `" Y  W$ B$ G6 ]5 I2 m2 Q+ }route of administration, delivery device, etc. has the potential to present
  b) s5 `3 ~$ v* H7 U4 tunique challenges and unanticipated problems, and should be approached
: T$ ^' }, v) j" ]6 ~with such a mindset. The pharmaceutical researcher must be free to design
and develop new ways to predict and measure stability-related issues
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
library of many pharmaceutical scientists. I am confident that the ‘‘artful
science’’ of stress testing will evolve beyond what is represented in this book
' |5 u; |4 a0 c7 m. ~* Zas other scientists further the science and fill in topics that are poorly covered
  ?  B$ `6 w. gor missing.
" x  T, H. o4 H6 L2 x
( Y: P: y# d" _; o

顶一下 只是英文不太好

看了我头好大

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？

呜呜呜呜  ，英语烂的我只有哭了哈