Handbook Generic Development
Oral Extended Release Capsules
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, 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
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 additional optional license)
0793-7456 / 0793-7764
All air shipping is 100% insured for loss or replacement. Shipping rates
are standard | Priority | Expedited.
Link | Handbook Series | Journal
Index | Specialized Journals