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Stress testing is the main tool that is used to predict stability problems,
6 @; O+ ]( A* h" d9 Jdevelop analytical methods, and identify degradation products/pathways.
1 U6 ~" Z5 c/ h( V( v+ I& d: |/ |! P# JSince there are no detailed regulatory guidelines that direct how stress testing
% k7 P3 R z2 l$ Qis to be done, nor has there ever been a text/reference book on the
7 N9 P g! M, f$ b# O/ osubject, stress testing has evolved into an artful science that is highly dependent. r5 ]; U; @3 x7 Y, E
on the experience of the company or the individuals directing the studies. This
% A8 n5 h4 N nbook provides readers with a single source reference that benchmarks the2 S% u3 F- v% e0 g7 c
current best practices of experienced pharmaceutical scientists/researchers. S8 {) K; Z/ P( s
Questions like ‘‘How hot, how long, what conditions are appropriate?’’ and
; U* {3 Q7 g' y% Mtopics such as mass balance, photostability, oxidative susceptibility, and the4 f. h4 {0 u& s$ }1 z7 [
chemistry of drug degradation are addressed in an objective, detailed scientific
/ v3 Z- p% ?0 A6 \manner, with ample references to relevant guidances and the scientific literature.
( ?1 K0 }6 Q, q1 B* ^( cCompiling a book to be used as a scientific reference for the topic of/ n! G4 Y' }4 w! i
pharmaceutical stress testing was a daunting task. Stress testing, as it relates
4 b8 y( N p9 h5 y o/ Zto traditional small molecule pharmaceuticals, is very broad and scientifically9 c( G/ d# C3 y# R, n8 l+ t0 C2 H
complex. Thus, this book seeks to be a practical and scientific guide2 U9 Z8 a8 J$ u1 f
which will, hopefully, stimulate new ideas and further development of the% s% w( v' T, I" M
science.: X; E/ ^# q4 H- f3 U
This undertaking is done with some trepidation, since I realize that discussion! [# J, o- p |/ Z: a$ k" C9 A6 L
of this topic could lead to attempts to formalize or standardize (i.e.,
* X- T0 B8 n4 H- h. C( a' u- Y& X% bregulatory standardization) an area of pharmaceutical science that relies on+ ~7 f7 d3 j. k C" s. B$ R& z
scientific expertise and flexibility. Each new drug compound, formulation,
* P F9 p3 @' _route of administration, delivery device, etc. has the potential to present
2 s+ Y) N, L5 }2 G; v! xunique challenges and unanticipated problems, and should be approached9 |& h K$ I6 \; T @
with such a mindset. The pharmaceutical researcher must be free to design8 k5 l# u3 R: Y
and develop new ways to predict and measure stability-related issues
9 f! d3 @( Q- kthrough stress testing. Nonetheless, it is hoped that this book will provide
: ~1 f8 ^( ? h+ z! ?- Oa useful and practical scientific guide that is a welcome addition to the
, @7 ?1 g, F6 N; ?0 o4 llibrary of many pharmaceutical scientists. I am confident that the ‘‘artful- z( \/ S% k, }3 @2 e% N% Z/ U
science’’ of stress testing will evolve beyond what is represented in this book& a5 {8 K* q. K% O
as other scientists further the science and fill in topics that are poorly covered
6 z$ g) H1 k( u1 ror missing.: F7 a4 A5 X/ x# A) k
: t) @3 ?9 E* z3 t E2 i) ] |