Promotes the development and sharing of practical drug
development knowledge and technology by agency and industry experts
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
LOCUM INT. PRESS
Vol, Edition # and Pub. Year.
H/B Vol 12/Ed 14 - 2014
H/B Vol 12/Ed 15 - 2015
H/B Vol 12/Ed 16 - 2016
H/B Vol 12/Ed 17 - 2017
H/B Vol 12/Ed 18 - 2018
H/B Vol 12/Ed 19 - 2019
H/B Vol 12/Ed 20 - 2020
New Edition Annually
Handbook Generic Development
Oral DR Tablets
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
Volume ~1800 pp fully
diagrams, graphs, tables in b/w & color.
All air shipping is 100% insured for loss
or replacement. Shipping rates
are | Standard | Priority | Expedited.
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Index | Specialized Journals