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.


"covers the entire FDA and OGD requirements and expectations and more
-Rhone-Polenc-Rorer"

LOCUM INT. PRESS
Vol, Edition # and Pub. Year.

H/B Vol 11/Ed 14 - 2014
H/B Vol 11/Ed 15 - 2015
H/B Vol 11/Ed 16 - 2016
H/B Vol 11/Ed 17 - 2017
H/B Vol 11/Ed 18 - 2018
H/B Vol 11/Ed 19 - 2019
H/B Vol 11/Ed 20 - 2020

New Edition Annually

Handbook Generic Development
Oral Extended Release 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, 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 additional 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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