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
"This softgel reference is truly unique and
"simply the best reference we've got" - RP Scherer.
LOCUM INT. PRESS
Vol, Edition # and Pub. Year.
H/B Vol 5/Ed 16 - 2016
H/B Vol 5/Ed 17 - 2017
H/B Vol 5/Ed 18 - 2018
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
New Edition Annually
Handbook Generic Development
A Two Part Development to
Final Production Handbook
Locum Press Edition International.
or 5-AE (Standard or Advanced Edition - Complete
Handbook in Two Parts) of the International 24 Volume
Drug Development Series
The Handbook of Pharmaceutical Generic Development is an essential workbook
and definitive reference covering the full and detailed development, CMC,
RA and legal sections for a single dose Soft Gelatin Capsule ANDA/CMC/Dossier
Module development project. Available in standard and advanced edition
in print and electronic CD or Online Dropbox. Advanced edition includes
gelcoated caplets [GCC] and formulations of gelcoated coatings of advanced
caplet coatings and gelcoated CR / MR caplets and softgels.
Each product specific handbook focuses exclusively on single dosage
form and in essence informs and guides the SGC innovator or product
developer (a) what exactly must be done (b) once it is completed how
to write and format the raw data (c) what the various agencies expects
to see in each section or module and (d) what the developer must not
leave out. Including all common tips, traps and pitfalls for the specific
dosage form. Copious and detailed checklists ensure that product development
has no developmental gaps, oversights or regulatory errors.
Each and every agency guideline and development requirement is thoroughly
dealt with, in a step-by-step manner, in order to avoid the pitfalls occurring
during product development. TOC for US and EU eCTD and CTD.
Provides essential SG Capsule and GCCaps technology know-how on
all aspects of development, formulation, formulation tables, current marketed
formulas. Equipment, scale-up, process optimization & qualification; troble
shooting, pivotal and large scale validation batches; analytical, cleaning
and process validation; essential documentation and OGD / EU regulatory
know-how that is essential for a successful review for a FDA /EU product
approval, saving lengthy queue-time and money. Product development budgets
can be reduded by up to 50% in the product development cycle, thus avoiding
all the common developmental dead-ends for this specific dosage form.
A reference for critical documentation and OGD / EU regulatory know-how
that is essential for a successful first time FDA / EU review and approval,
saving months of queue-time, developmental, regulatory and production
dead-ends and lost market place sales of not being first in the approval
Every regulatory guideline is covered in clear explanatory detail providing
a development protocol for a totally omission-free file submission.
Essential development know-how on Oral Soft Gelatin capsules and gelatin
coated caplets, GCCaps (in popular US / EU OTC and prescription commercial
formulations namely Ibuprofen, Na Naproxacin 220mg, KI etc. for advanced
developers to understand the nuts-and-bolts of generic SGC and GCC development
with corresponding high-tech, detailed advanced US and EU developmental
/ registration and commercial production technology and inhouse know-how.
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
Complete Volume in two parts 1890-1990 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) or via digital
CD read onlt and printable editions (10, 25 & 50 multi-users require
additinal optional license). Split
volume attract a 25% handling and broken volume charge to split the two
All air shipping is 100% insured for loss
or replacement. Shipping rates
are: | Standard | Priority | Expedited.|
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