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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.


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

"The most comprehensive reference works in our reference library" - KRKA.



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

H/B Vol 3/Ed 14 - 2014
H/B Vol 3/Ed 15 - 2015
H/B Vol 3/Ed 16 - 2016
H/B Vol 3/Ed 17 - 2017
H/B Vol 3/Ed 18 - 2018
H/B Vol 3/Ed 19 - 2019
H/B Vol 3/Ed 20 - 2020

New Edition Annually.

Locum Publishers Clients
(Handbooks and Journals

Handbook Generic Development
Semisolids Topical

A Two Part Development To Final Production Handbook
Creams / Gels / Ointments

Locum International Press

Volume 3 - (Complete Handbook in Two Parts)
of the International 24 Volume Drug Development Series


Handbook of Pharmaceutical Generic Development - Complete coverage from pre-formulation of Generic CTD/ ANDA to final FDA filing - detailing more than 150 key product development steps. Developmental Checklists clarify the key Generic issues that the FDA routinely address during CTD/ANDA file review and pre-approval inspection.

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 appliations made simple and precise.

Checklists dovetail with Guidelines on a key Standard Operating Procedure detailing real-life examples from A (actives) to V (validation). Packed with hands-on Charts, Diagrams SOPs, Summaries, Tables and guidelines.

Describes over 150 drug development steps. Each development stage is supplemented with unique Checklists and specific key Development SOPs.

Who this book is for: This handbook of Pharmaceutical Generic Development is an essential workbook for the full CTD/CMC and eCTD development and all modules required for of a fault free generic development.

Product Development know-how provides development, formulation, diffusion profiles, stability, full specifications, process optimization & qualification, scale-up, pivotal batch, technical transfer documentation, analytical cleaning and commercial batch-size process validation.

Inter-linked with legal and regulatory know-how that is essential for a successful review for a FDA approval, saving queue-time and money.

Essential reading for Development Pharmacists, R&D Chemists, QA and regulatory personnel. Allows management to understand the nuts and bolts on Generic US ANDA development and filing in the most cost effective way. A complete training model for US and EU pharmaceutical graduates

Readership
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.

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 open flat) or via digital CD (multi-users require additinal optional license) ISBN: 0793-8676 / 0793-8689

About Us
Locum International Press are one of the world leading scientific R&D publishers offering an exceptional range of peer reviewed journals, handbooks, book databases and publishing services to the pharmaceutical science community. We also offer a large and comprehensive range of product specific generic handbooks to the pharmaceutical generic drug and innovative drug R&D community.


Price:
Locum International Catalog

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