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 ER Capsules
A Two Part Development
Handbook
Locum International Press
Volume 11 -
(Complete Handbook in Two Parts)
of the International 24 Volume Drug Development Series
The Handbook of Pharmaceutical Generic Development is an essential workbook
covering the Full Development, CTD/CMC including Production/QC/QA/Validation/
RA sections for a ER & SR [MR] CAPSULE development program.
ER Development with detailed
commercial and state-of-the-art MR formulae and manufacturing processes)
provides essential ER Capsule Technology know-how on all aspects of; development,
formulation, dissolution, stability specification, scale-up, process optimization
& Qualification; Pivotal and Large Scale Validation batches using both
pan and Wurster Spray Granulators (GPCG 60/120); ER analytical methodology;
dissolution, cleaning and process validation; essential documentation
and OGD Regulatory / R&D know-how, essential for a successful review &
FDA approval, saving queue-time and money.
Essential development know-how on Oral ER/SR Capsule for advanced developers
to understand the nuts-and-bolts on Generic MODIFIED RELEASE development
with a state-of-the-art high-tech detailed working model systems to produce
flawless modules/files and applications
Complete
Volume in two parts 1890-2000 pp. Part 1 and 2 fully illustrated and annotated
with diagrams, flow charts, formula, graphs, spectra, side-by-side comparisons,
tables in b/w & color. Available in print (spiral soft cover opens
flat) or via digital CD (multi-users require additinal optional license)
ISSN:
0793-7407 / 0793-7792
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air shipping is 100% insured for loss or replacement. Shipping rates
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