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.
"No development unit should be without it -Pliva
Handbook Generic Development
Oral IR Suspensions
A Two Part Development Handbook
Locum International Press
Volume 07
- (Complete Handbook in Two Parts)
of the 24 Volume Drug Development Series
This definitive Handbook of Pharmaceutical Generic Development is an essential
workbook covering the full CMC & Bio and RA sections of normal oral suspension
ANDA and Suspension for Reconstitution. TOC for US and EU eCTD and CTD.
Part Two (ANDA Development with detailed
commercial and state-of-the-art formula provides essential know-how technology
on all aspects of formatting and documentation and OGD regulatory know-how
that is essential for a successful review for a FDA approval, saving queue-time
and money.
Over five years in preparation and claimed as the world's most authoritative
and definitive work available on oral dosage form drug development from
a generic industry viewpoint. An essential reference for development pharmacists,
R&D chemists, QA/QC and regulatory personnel.
Key development know-how on Oral Suspensions and Suspensions for Reconstitution
directed to professional developers to understand the nuts-and-bolts on
Generic ANDA DEVELOPMENT to produce flawless files
Complete
Volume in two parts 1690-1850 pp. Part 1 and 2 fully illustrated with
diagrams, flow charts, graphs, side-by-side comparisons, tables in b/w
& color. Available in print (spiral soft cover) or via digital CD
(multi-users require additinal optional license)
ISBN: 0793-0032
/ 0793-0033
All air shipping
is 100% insured for loss or replacement. Shipping rates
are:
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Price: Locum
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