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.

"covers the entire FDA and OGD requirements and expectations and more

"..very successful ANDAs
achieved with this know-how" - KRKA


Vol, Edition # and Pub. Year.

H/B Vol 12/Ed 18 - 2018
H/B Vol 12/Ed 19 - 2019
H/B Vol 12/Ed 20 - 2020
H/B Vol 12/Ed 21 - 2021
H/B Vol 12/Ed 22 - 2022
H/B Vol 12/Ed 23 - 2023
H/B Vol 12/Ed 24 - 2024

New Updated Edition Annually

Handbook Generic Development
Oral DR Tablets

A Two Part Development To Final Production Handbook

Locum International Press.

Volume 12 - (Complete Handbook in Two Parts)
of the 24 Volume Drug Development Series

This Handbook of Pharmaceutical Generic Development is a practical hands-on workbook and definitive reference work on development requirements needed for a Oral DR Tablet (Spay Granulation Enteric Coated Delayed Release).

Part One
covers pharmaceutical drug development provide formula and coat know-how for the Development, Pre-formulation, Dissolution Stability, Impurity Profiling, Analytical Validation, Final Formulation, Scale-up, Process Qualification; Pivotal, commercial and final validation batches; as well as analytical, cleaning and process validation protocols Practical key documentation and OGD regulatory know-how that is essential for a successful review for a FDA approval, saving queue-time and money.

Designed to specifically eliminate the potential risks and common process omissions in drug development and claimed as the world's most authoritative and definitive work available on oral dosage form drug development from a generic industry viewpoint.

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.

Master Formula and detailed step-by-step processes are current US and EU commercial generic drug product leaders. Essential development and submission know-how on Delayed Release Oral Tablets for professional generic developers to understand the nuts-and-bolts on Generic ANDA development with a high-tech detailed working commercial ANDA know-how for quick approval of ANDA files

Complete Volume ~1800 pp fully illustrated with diagrams, graphs, tables in b/w & color.

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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