LOCUM INT. PRESS
Vol, Edition # and Pub. Year.
H/B Vol 11/Ed 18 - 2018
H/B Vol 11/Ed 19 - 2019
H/B Vol 11/Ed 20 - 2020
H/B Vol 11/Ed 21 - 2021
H/B Vol 11/Ed 22 - 2022
H/B Vol 11/Ed 23 - 2023
H/B Vol 11/Ed 24 - 2024
New Updated Edition Annually
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Handbook Generic Development
Oral ER Capsules
A
Two Part Development To Final Production 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.
SEAMLESS
INTEGRATION
An Essential Reference for Development Pharmacists, R&D Chemists, QA/QC
and Regulatory personnel. Each and every document, protocol and procedure
in Part I + II is expertly referenced to the appropriate module number
in the CTD / e-CTD system thus providing a fully seamless and effortless
integration into either US, EU and Asian application files and dossier.
All IAGIM technology is purposely and uniquely dove-tailed in regulatory
drug product applications -worldwide appliations made simple and precise.
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
All
air shipping is 100% insured for loss or replacement. Shipping rates
are:
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Price:
Locum
International Catalog
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