Available: Print or CD
(Format PDF or Word.rtf)
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 anywhere.
"Your truly unique and excellent series - Ranbaxy"
"very comprehensive indeed" -
"All our departmental SOPs initially started from
your excellent SOP system - and we simply built on the IAGIM structure"
" IVAX used your 3 SOP CD Set in Ireland and USA and we redid our
analytical laboratories from A-Z IvaxNortons (prior
to the TEVA aquisition)
" Our Tamoxifen 10/20/40mg was approved in record time in the UK
and EU - based on your technology - Nortons Ir.
(Now IVAX FL USA)
"The agency advised us to get your system - we did
and our firm got US FDA agency approval - Matrix
"We use your SOP system - worldwide"
LOCUM INT. PRESS
Vol, Edition # and Pub. Year.
H/B Vol 6/Ed 18 - 2018
H/B Vol 6/Ed 19 - 2019
H/B Vol 6/Ed 20 - 2020
H/B Vol 6/Ed 21 - 2021
H/B Vol 6/Ed 22 - 2022
H/B Vol 6/Ed 23 - 2023
H/B Vol 6/Ed 24 - 2024
New Updated Edition Annually
Handbook Generic Development
Three Part Development To Final Production Handbook
Locum International Press
Volume 6 (Complete
Handbook in Three Parts)
of the 24 Volume Drug Development Series.
Print + Electronic Standard Operating Procedures in PDF or Word.rtf (Editable)
Available in Print or two CD formats for immediate in-house use. Working
examples provided on how to convert development SOPs into your own customised
research-based-development system that meet all international regulatory
guides, guidelines and regulatory requirements.
e-SOPs provide Development, Decision Trees,
Formulation, Scale-up, Process Optimization & Qualification; pivotal and
final large scale validation batches; analytical, cleaning and process
validation; essential documentation and generic regulatory know-how that
is essential for a successful product development and a speedy FDA approval,
saving queue-time and development dollars.
Essential information for Development Pharmacists, R&D Chemists, QA and
Regulatory personnel. Allows management to understand the nuts and bolts
on Generic CTD/ANDA and EC Development and filing in the most cost effective
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 three parts 1790-1850 pp. Parts 1, 2 and 3 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 (multi-users require additinal optional license).
All air shipping is 100% insured for loss or replacement.
Shipping rates are: | Standard
| Priority | Expedited.|
Link | Handbook Series | Journal
Index | Specialized Journals