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Stress testing is the main tool that is used to predict stability problems,+ K# i% _3 w# E! f X9 S
develop analytical methods, and identify degradation products/pathways.
, u' F" s5 K+ i( Y0 \+ r3 ~0 KSince there are no detailed regulatory guidelines that direct how stress testing
4 l& J$ V5 t- p! lis to be done, nor has there ever been a text/reference book on the8 X9 c7 A* p, ~; y# I
subject, stress testing has evolved into an artful science that is highly dependent2 V9 n, v8 A& p3 `+ d6 _
on the experience of the company or the individuals directing the studies. This8 s9 q2 ~2 {, Z
book provides readers with a single source reference that benchmarks the
3 Y) n8 P: |% C4 B1 scurrent best practices of experienced pharmaceutical scientists/researchers.
% H- w3 v$ O* W0 y' SQuestions like ‘‘How hot, how long, what conditions are appropriate?’’ and, }- ~+ ]4 |. Y$ s
topics such as mass balance, photostability, oxidative susceptibility, and the
- |, [8 o5 i" o9 V3 B# [chemistry of drug degradation are addressed in an objective, detailed scientific
- W7 c# ~9 O1 w! }/ hmanner, with ample references to relevant guidances and the scientific literature.& d1 C8 v' j2 E% ^7 Y9 f
Compiling a book to be used as a scientific reference for the topic of6 I% @9 |. ?1 a
pharmaceutical stress testing was a daunting task. Stress testing, as it relates2 ]* |1 n1 }* D; d
to traditional small molecule pharmaceuticals, is very broad and scientifically
7 q' v$ d3 `# q1 Pcomplex. Thus, this book seeks to be a practical and scientific guide
$ @ g+ Z% S# p0 v9 a7 Hwhich will, hopefully, stimulate new ideas and further development of the
+ H. H, Q" h2 `science.6 ^! I- m# Z1 ]9 @1 S5 x: G, Z
This undertaking is done with some trepidation, since I realize that discussion b, d, J- A/ e K9 K
of this topic could lead to attempts to formalize or standardize (i.e.,
. [) ^( O9 U$ \' [6 Z4 sregulatory standardization) an area of pharmaceutical science that relies on9 o! \! ]% }! ?9 d6 f7 S5 u E
scientific expertise and flexibility. Each new drug compound, formulation,
0 f7 p* f m) e$ `. }route of administration, delivery device, etc. has the potential to present
. T( g$ J- B6 {4 t0 |& f9 V tunique challenges and unanticipated problems, and should be approached/ \; k! ^# Q* `4 G, X8 J# F! [
with such a mindset. The pharmaceutical researcher must be free to design1 Z( |6 B% f' F& N/ P
and develop new ways to predict and measure stability-related issues1 Q3 p2 C3 h; S
through stress testing. Nonetheless, it is hoped that this book will provide
( j9 @- N9 \( e- a& u' ?a useful and practical scientific guide that is a welcome addition to the. k- I6 z9 d& F- s+ V- s' o+ N4 a
library of many pharmaceutical scientists. I am confident that the ‘‘artful
, {* W( a# @: ]' a) gscience’’ of stress testing will evolve beyond what is represented in this book$ E4 L8 i2 g& q8 F/ H: ]
as other scientists further the science and fill in topics that are poorly covered
# J6 W5 U, A! `. \or missing.
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