Promotes the development and sharing of
practical drug development knowledge and technology by agency and industry
The world's most definitive & authoritative current generic drug
development series available.
"Very satisfactory - a truly excellent series"-
"The most comprehensive reference
works in our reference library" - KRKA.
LOCUM INT. PRESS
Vol, Edition # and Pub. Year.
H/B Vol 4/Ed 19 - 2019
H/B Vol 4/Ed 20 - 2020
H/B Vol 4/Ed 21 - 2021
H/B Vol 4/Ed 22 - 2022
H/B Vol 4/Ed 23 - 2023
H/B Vol 4/Ed 24 - 2024
H/B Vol 4/Ed 25 - 2025
New Updated Edition Annually.
Locum Publishers Clients
(Handbooks and Journals
Handbook Generic Development
Two Part Development To Final Production Handbook
/ Gels / Ointments
Locum International Press
Volume 3 -
(Complete Handbook in Two Parts)
of the International 24 Volume Drug Development Series
Handbook of Pharmaceutical Generic Development - Complete coverage from
pre-formulation of Generic CTD/ ANDA to final FDA filing - detailing more
than 150 key product development steps. Developmental Checklists clarify
the key Generic issues that the FDA routinely address during CTD/ANDA
file review and pre-approval inspection.
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.
Checklists dovetail with Guidelines on a key Standard Operating Procedure
detailing real-life examples from A (actives) to V (validation). Packed
with hands-on Charts, Diagrams SOPs, Summaries, Tables and guidelines.
Describes over 150 drug development steps.
Each development stage is supplemented with unique Checklists and specific
key Development SOPs.
Who this book is for: This handbook of Pharmaceutical Generic Development
is an essential workbook for the full CTD/CMC and eCTD development and
all modules required for of a fault free generic development.
Product Development know-how provides development, formulation, diffusion
profiles, stability, full specifications, process optimization & qualification,
scale-up, pivotal batch, technical transfer documentation, analytical
cleaning and commercial batch-size process validation.
Inter-linked with legal and regulatory know-how that is essential for
a successful review for a FDA approval, saving queue-time and money.
Essential reading for Development Pharmacists, R&D Chemists, QA and regulatory
personnel. Allows management to understand the nuts and bolts on Generic
US ANDA development and filing in the most cost effective way. A complete
training model for US and EU pharmaceutical graduates
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
Note: Strongly recommended for innovative drug development, highlighting all common tips and traps of experienced drug developers.
Volume in two parts 2000 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 open flat) or via digital CD (multi-users require additinal optional license)
Note: Strongly recommended for innovative drug development, highlighting all common tips and traps of highly experienced innovative drug developers
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 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.
All courier air shipping is 100% replacement insured
for courier loss or damage Shipping rates
are: | Standard | Priority | Expedited.|
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