Available: Print or CD
Promotes the development and sharing of practical drug
development knowledge and technology by agency and industry experts
alike.
The world's most definitive & authoritative current generic drug
development series available.
"very satisfactory - a truly excellent series"-
LEK dd.
Handbook Drug Development
Process Validation
A Four Part Development
Handbook
Locum International Press
Volume 14 -
(Parts 1 to 4)
of the 24 Volume Drug Development Series.
Part One
to Part Four
provide Development, Formulation, Scale-up Process Qualification; pivotal
and final end product validation batches; analytical, cleaning and commercial
process validation; essential documentation, pivotal and commercial protocols,
validation reports and generic regulatory know-how that is essential for
a successful review for a FDA/EU approval, saving queue-time and money.
Essential development know-how on all aspects of
Process Validation for professional developers to understand the
nuts-and-bolts on Generic CTD/ANDA development including high-tech detailed
working modules and systems for CTD/ANDA targeting fault-free approval
of CTD/ANDA documents.
Complete Volume ~1800 pp for Part 1 to
4 fully illustrated
with diagrams, graphs, tables in b/w & color.
ISSN:
0793-8799 / 0793-8802
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