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The world's most definitive & authoritative current generic drug
development series available.
"This softgel handbook is truly a unique and excellent authoritative
reference source - Ranbaxy"
An amazing publication for Softgel development and production
- Scherer (GMB)
"Simply the best reference we've got - this book is totally unique"
- RP Scherer
The best Soft Gelatin Caps / Softgels handbook we have
ever seen in print - Teva Group
LOCUM INT. PRESS
Vol, Edition # and Pub. Year.
H/B Vol 5/Ed 19 - 2019
H/B Vol 5/Ed 20 - 2020
H/B Vol 5/Ed 21 - 2021
H/B Vol 5/Ed 22 - 2022
H/B Vol 5/Ed 23 - 2023
H/B Vol 5/Ed 24 - 2024
H/B Vol 5/Ed 25 - 2025
New Updated Edition Annually.
Locum Publishers Clients
(Handbooks and Journals
Handbook Generic Development
A Two Part Development to Final
Locum International Press
(Complete Handbook in Two Parts)
of the International 24 Volume Drug Development Series
SGC Handbook provides essential SG
capsule technology know-how on all aspects of development, pre-formulation,
final formulation, scale-up, process optimization & process qualification;
pivotal and large scale validation batches; analytical, cleaning and process
validation; essential documentation, protocols, checklists, flowcharts
and key SOPS designed in compliance with international regulatory know-how
that is essential for a successful review for a EU / FDA / ICH / Asian
product development and approval, saving valuable queue-time and costly
The Handbook of Pharmaceutical Generic Development is avaiolable as a
STANDARD or ADVANVED EDITION. Updated annually it is an essential A to
Z SGC workbook covering modern technological advances, do's and don'ts,
lastest SGC development technology, complete analytical methology, production
CMC / CTD modules and sections for a single dose Soft Gelatin Capsule
CTD / ANDA development project up to and including full size large-scale
commercial production batchlots.
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.
Critical and key
development know-how on Oral Soft Gelatin Capsule for advanced developers
to understanding international compliance management and the nuts-and-bolts
on Generic SGC Development and manufacture maximizing your detailed and
comprehensive high-tech FDA-EU-ICH working knowledge of Soft Gelatin Capsule
know-how and particle engineering technologies for better drug performance
(including nanodosage forms)
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
0793-8675 / 0793-8683
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 an unique 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.
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