IAGIM - Drug Development Association

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. - Int Pharm Journal

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

Great analytical, process validations and protocol - our system uses these workable models - TEVA US

A comprehensive teaching model - Wisconsin Univ USA

Impressive Handbook on validation - Mallinckrodt

It all we needed to get our processes approved - Ranbaxy

The handbook meets our validation needs from analytical to final product - IVAX

We changed our entire laboratory system and procedures - IVAX Ireland.

Vol, Edition # and Pub. Year.

H/B Vol 9/Ed 18 - 2018
H/B Vol 9/Ed 19 - 2019
H/B Vol 9/Ed 20 - 2020
H/B Vol 9/Ed 21 - 2021
H/B Vol 9/Ed 22 - 2022
H/B Vol 9/Ed 23 - 2023
H/B Vol 9/Ed 24 - 2024

New Updated Edition Annually

Handbook Drug Development
Process Validation

A Four Part Development Handbook

Locum International Press

Volume 23 - (Parts 1 to 4)
of the 24 Volume Drug Development Series.

Part One to Part Four provide Development, Formulation, Scale-up Process Qualification; pivotal and final end product validation batches; analytical, cleaning and commercial process validation; essential documentation, pivotal and commercial protocols, validation reports and generic regulatory know-how that is essential for a successful review for a FDA/EU approval, saving queue-time and money.

Essential development know-how on all aspects of Process Validation for professional developers to understand the nuts-and-bolts on Generic CTD/ANDA development including high-tech detailed working modules and systems for CTD/ANDA targeting fault-free approval of CTD/ANDA documents.

Complete Volume ~1800 pp for Part 1 to 4 fully illustrated with diagrams, graphs, tables in b/w & color. Table of Contents.

ISSN: 0793-8799 / 0793-8802
All air shipping is 100% insured for loss or replacement. Shipping rates are:
| Standard | Priority | Expedited.|

Price: Locum International Catalog


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