IAGIM - Drug Development Association

Available: Print

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.

"No development unit should be without it -Pliva"



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


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.

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.

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

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Price: Locum International Catalog

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