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Stress testing is the main tool that is used to predict stability problems,7 x _' a" |6 n- z! S& _
develop analytical methods, and identify degradation products/pathways.
1 c7 C$ Z* [+ e: i, |Since there are no detailed regulatory guidelines that direct how stress testing' A% `0 A! n3 A( n* F* D. \' e
is to be done, nor has there ever been a text/reference book on the+ s) d4 }5 m% B2 r0 z+ e
subject, stress testing has evolved into an artful science that is highly dependent8 ]7 s) Y- Y8 d
on the experience of the company or the individuals directing the studies. This3 F2 ~6 D+ C1 }3 d
book provides readers with a single source reference that benchmarks the6 l; E+ P8 q/ _, {1 t, w
current best practices of experienced pharmaceutical scientists/researchers.9 _& D' l7 \: w# d; g
Questions like ‘‘How hot, how long, what conditions are appropriate?’’ and& P! u1 b4 j: `5 n, @2 y9 X
topics such as mass balance, photostability, oxidative susceptibility, and the4 u9 V9 }, j J. q0 j9 X
chemistry of drug degradation are addressed in an objective, detailed scientific& @! F9 G# o: G# L
manner, with ample references to relevant guidances and the scientific literature./ f' W& h4 N% h+ b) e. a5 D9 h" e1 u
Compiling a book to be used as a scientific reference for the topic of
. u( d6 u0 L ~/ k8 m, Ypharmaceutical stress testing was a daunting task. Stress testing, as it relates. l0 p9 I0 ~: r7 _
to traditional small molecule pharmaceuticals, is very broad and scientifically
) n- ?, \! H7 n! f' Z0 E* |8 C$ @/ Mcomplex. Thus, this book seeks to be a practical and scientific guide
8 Z! R) h9 M+ `4 lwhich will, hopefully, stimulate new ideas and further development of the
6 l1 b6 T& [; v" w8 e$ }science.
, D) ]( N+ j; W- Y; ?This undertaking is done with some trepidation, since I realize that discussion
; Y/ r H t+ [; s" {- \( F* @of this topic could lead to attempts to formalize or standardize (i.e.,
4 V7 z$ E( I2 F: p: h! ?5 f7 oregulatory standardization) an area of pharmaceutical science that relies on3 d7 L3 W$ V: }8 p
scientific expertise and flexibility. Each new drug compound, formulation,
2 T g4 T' u# I6 m* s" E8 Troute of administration, delivery device, etc. has the potential to present! I" W3 K5 Q9 e3 l+ [
unique challenges and unanticipated problems, and should be approached
, U3 r: k+ R+ g& P# G. Z$ u2 Zwith such a mindset. The pharmaceutical researcher must be free to design _: H; z. r7 M, A1 |& F0 s0 S/ p
and develop new ways to predict and measure stability-related issues
7 W6 v" Y0 i- Qthrough stress testing. Nonetheless, it is hoped that this book will provide# L3 H9 q& G$ b" l, p% h3 M9 |4 {
a useful and practical scientific guide that is a welcome addition to the
' d8 B. w$ v% _7 ]library of many pharmaceutical scientists. I am confident that the ‘‘artful
$ H% |. ?4 O i, K8 gscience’’ of stress testing will evolve beyond what is represented in this book
* m+ F, H& V' c. X. p. a. |as other scientists further the science and fill in topics that are poorly covered' C' P1 {4 ^! g; b P$ U6 ^
or missing.
8 s0 G" F+ i1 n" Z5 b1 ~
. S) j* U( T& {$ e |
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