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 anywhere.



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

H/B Vol 15/Ed 16 - 2016
H/B Vol 15/Ed 17 - 2017
H/B Vol 15/Ed 18 - 2018
H/B Vol 15/Ed 19 - 2019
H/B Vol 15/Ed 20 - 2020
H/B Vol 15/Ed 21 - 2021
H/B Vol 15/Ed 22 - 2022
H/B Vol 15/Ed 23 - 2023
H/B Vol 15/Ed 24 - 2024

New Edition Annually.

Locum Publishers Clients
(Handbooks and Journals)

Handbook Generic Development
Oral Capsules - (All Dosage Forms)
A Two Part Development To Final Production Handbook

Locum International Press.

Volume 15 - (IR, ER, SR, SGC)
24 Volume Drug Development Series.

Availability Print - (Four Dosage forms)

This Handbook of Pharmaceutical Drug Development is a practical hand-on workbook covering all aspects of drug development in four types of single dose oral capsules for both immediate and extended release.

Covers pharmaceutical drug development by providing hands-on easy-to-understand current know-how for the development, formulation, dissolution, scale-up, process optimization and qualification; stability, pivotal (bio) and final validation batch lots.

Includes analytical, cleaning and process validation, critical and essential documentation peppered with legal and regulatory know-how that is essential for a first time successful review for a FDA approval, saving queue-time and lost market sales.

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 applications made simple and precise.

Essential development and submission know-how on immediate and extended release oral capsules for the professional drug developer to really understand the nuts-and-bolts of capsule drug development with a high-tech integrated formulation charts, unique and advanced developmental procedures, flowcharts, decision trees, tables, development SOPs, checklists and much more.

Complete Volume ~1800 pp for Part 1 to 4 fully illustrated with diagrams, graphs, tables in b/w & color as a complete volume in four parts.

ISSN: 0793-7763 / 0793-7764

Price: Locum International Catalog




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