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.
Note: Strongly recommended for innovative drug development, highlighting all common tips and traps of highly experienced innovative drug developers

"Very satisfactory - a truly excellent series"- LEK dd.

Vol, Edition # and Pub. Year.

H/B Vol 2/Ed 19 - 2019
H/B Vol 2/Ed 20 - 2020
H/B Vol 2/Ed 21 - 2021
H/B Vol 2/Ed 22 - 2022
H/B Vol 2/Ed 23 - 2023
H/B Vol 2/Ed 24 - 2024
H/B Vol 2/Ed 25 - 2025

Updated Edition Annually

Locum Publishers Clients
(Handbooks and Journals

Handbook Generic Development
Oral IR Capsules
A Two Part Development To Final Production Handbook

Locum International Press

Volume 2 - (Complete Handbook in Two Parts)
of the International 24 Volume Drug Development Series

This definitive annually updated Handbook of Pharmaceutical Generic Development is an essential workbook and reference workbook covering the RA sections for a single dose capsule ANDA development project. It promotes the development and sharing of practical drug development knowledge and solid dose technology from government agency and industry experts alike. TOC for US and EU eCTD and CTD.

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.

Each product specific handbook focuses exclusively on single dosage form and in essence informs and guides the product developer (a) what exactly must be done (b) once it is completed how to write and format the raw data (c) what the agency expects to see in each section and (d) what the developer must not leave out.

Each and every agency guideline and development requirement is thoroughly dealt with in a step-by-step manner in order to avoid the common and unusual pitfalls occurring during routine product development, scale-up and final end-roduct validation including all aspects of analytical and production development.

Provides extensive Drug Development know-how in the CTD/ANDA development with detailed commercial and state-of-the-art formula and comprehensive process instructions. Complete legal format and key example forms and explanations on patents and exclusivity sectors.

Key documentation and OGD regulatory know-how that is essential for a successful review for a FDA approval, saving queue-time and money. Essential development know-how on Oral Capsules for professional developers to understand the nuts-and-bolts on Generic CTD/ANDA Development to produce flawless files for submission.

Development pharmacists, R&D chemists and scientists in pharmaceutical companies and university departments, in the areas of innovative, new drugs and generic drug development, QA / QC validation and regulatory personnel.

Note: Strongly recommended for innovative drug development, highlighting all common tips and traps of experienced drug developers.
Complete Volume in two parts 1690-1850 pp. Part 1 and 2 fully illustrated with diagrams, flow charts, graphs, 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)

ISBN: 0793-8655 / 0793-8653
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Price - Go to: Locum International Catalog

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