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.
"covers the entire FDA and OGD requirements
and expectations and more
-Rhone-Polenc-Rorer"
LOCUM INT. PRESS
Standard & Advanced Edition # and Pub. Year
H/B Vol 10 -2010
H/B Vol 11 -2011
H/B Vol 12 -2012
H/B Vol 13-2013
H/B Vol 14-2014
H/B Vol 15-2015
H/B Vol 16-2016
H/B Vol 17-2017
H/B Vol 18-2018
H/B Vol 19-2019
New Edition Annually
Print or electronic. Licenced or unlicenced.
Printable or read only e-editions.
Handbook Generic Development
Oral Extended Release 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, CMC and QA/RA sections for a ER & SR [MR]
CAPSULE development program. Table of Contents for both US and EU eCTD
and CTD modules.
Comprehensive Drug 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 high-tech detailed working model ANDA to produce flawless files
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:
0793-7456 / 0793-7764
All air shipping is 100%
insured for loss or replacement. Shipping rates
are standard | Priority | Expedited.
Price: Locum
International Catalog
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Ready-To-Go
Link | Handbook Series | Journal
Index | Specialized Journals
|
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)
