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.


"No development unit should be without it -Pliva"

"what a pleasant surprise to our R&D department -
Mallinckrodt.

 

 

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

H/B Vol 10/Ed 14 - 2014
H/B Vol 10/Ed 15 - 2015
H/B Vol 10/Ed 16 - 2016
H/B Vol 10/Ed 17 - 2017
H/B Vol 10/Ed 18 - 2018
H/B Vol 10/Ed 19 - 2019
H/B Vol 10/Ed 20 - 2020

New Edition Annually

Handbook Generic Development
Oral Controlled Release Tablets

A Two Part Development To Final Production Handbook

Locum International Press

Volume 10 -
(Complete Handbook in Two Parts)
of the International 24 Volume Drug Development Series


Handbook of Pharmaceutical Generic Development is a fully comprehensive practical hands-on workbook covering modern drug development and the full CTD section interactions of a Extended or Modified Controlled Release Oral Tablet or Caplet.

Advanced Development and process validation provide development, master drug formulations, key processes, scale-up; process optimization & qualification; stability; pivotal and final process validation Know-how and protocols; PAI, analytical, cleaning and process validation with comprehensive do's & don'ts check lists to eliminate common development faults.

An authoritative reference system for critical documentation and CTD know-how that is essential for a successful first time FDA review and approval, saving months of queue-time and market place sales.

Each and every regulatory guideline is covered in clear detail providing a development protocol for a totally omission-free file submission.

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.

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.

Allows management to understand the nuts and bolts on Generic ANDA DEVELOPMENT and filing and how to get to the market place - quickly and on time.

Complete Volume in two parts 1890-2000 pp. Part 1 and 2 fully illustrated and annotated with diagrams, flow charts, formula, graphs, spectra, 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). Split volume attract a 25% handling and broken volume charge to split the two part volume.

ISSN:
0793-8772 / 0793-8780

All air shipping is 100% insured for loss or replacement. Shipping rates are: | Standard | Priority | Expedited.|

Price go to: Locum International Catalog



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