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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