Promotes the development and sharing of
practical drug development knowledge and sterile technology by agency
and industry experts alike.
The world's most definitive & authoritative current generic drug
development series available anywhere.
LOCUM INT. PRESS
Vol, Edition # and Pub. Year.
H/B Vol 20/Ed 19 - 2019
H/B Vol 20/Ed 20 - 2020
H/B Vol 20/Ed 21 - 2021
H/B Vol 20/Ed 22 - 2022
H/B Vol 20/Ed 23 - 2023
H/B Vol 20/Ed 24 - 2024
H/B Vol 20/Ed 25 - 2025
New Updated Edition Annually
Locum Publishers Clients
(Handbooks and Journals)
Handbook Generic Development
Two Part Development To Final Production Handbook
Locum International Press.
Volume 20 -
(Complete Handbook in Two Parts)
of the International 24 Volume Drug Development Series
This advanced drug development Handbook of Pharmaceutical Generic Development
covers the key essential aspects of the development, formulation and manufacture
of sterile injections. It promotes the development and sharing of practical
drug development knowledge and sterile dose technology from government
agency and industry experts alike.
Covering pharmaceutical drug development by providing hands-on easy-to-understand
current know-how for the sterile product development, formulation, container
closure, scale-up, process optimisation and qualification, Sterile GMP,
aseptic procedures, stability, pivotal and comercial validation procedures
of sterile batch lots (Aqueous and lyophilized) with supporting SOPs,
protocols and checklists at every development and processing stage.
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 applications made simple and precise.
Includes IQ, OQ, PQ and equipment validation and comprehensive validation
checklists up to end-process validation, analytical, cleaning and process
validation, critical and essential documentation peppered with extensive
legal and regulatory know-how that is essential for a first time successful
review for a FDA approval, saving queue-time and lost market sales.
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
ISSN 0793-8754 / 0793-8744
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