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.
"No development unit should be without it -Pliva"
LOCUM INT. PRESS
Edition # and Pub. Year.
H/B Vol 10 - 2010
H/B Vol 11 - 2011
H/B Vol 12 - 2012
H/B Vol 13 - 2013
New Edition Annually
AVAILABILITY
a) Print
b ) Electronic CD - Read only (single user)
c ) Electronic CD - Print (Corporate user)
and may be
d ) Electronic CD - Licenced (Corporate
user)
e ) Electronic CD - Unlicenced
(Corporate
user)
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). Split
volume attract a 25% handling and broken volume charge to split the
two part volume.
ISSN:
0793-7407 / 0793-7792
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