Available: Print, Online DropBox or CD
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.
"This softgel handbook is truly a unique and excellent authoritative
reference source - Ranbaxy"
"Simply the best reference we've got" - RP Scherer
LOCUM INT. PRESS
Standard & Advanced Edition # and Pub. Year
H/B Vol 10 -2010
H/B Vol 11 -2011
H/B Vol 12 -2012
H/B Vol 13-2013
H/B Vol 14-2014
H/B Vol 15-2015
H/B Vol 16-2016
H/B Vol 17-2017
H/B Vol 18-2018
H/B Vol 19-2019
New Edition Annually
Print or electronic. Licenced or unlicenced.
Printable or read only e-editions.
Handbook Generic Development
Soft
Gelatin Capsules
A Two Part Development Handbook
Locum International Press
Volume 05 -
(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 development dollars.
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.
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 part volume.
ISBN: 0793-8675
/ 0793-8683
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