LOCUM INT. PRESS
Vol, Edition # and Pub. Year.
H/B Vol 19/Ed 14 - 2014
H/B Vol 19/Ed 15 - 2015
H/B Vol 19/Ed 16 - 2016
H/B Vol 19/Ed 17 - 2017
H/B Vol 19/Ed 18 - 2018
H/B Vol 19/Ed 19 - 2019
H/B Vol 19/Ed 20 - 2020
New Edition Annually
Handbook Generic Development
& PAI Checklists
Locum International Press.
Volume 19 - 1 - 4 (A Four Part Volume)
24 Volume Drug Development Series
Electronic Standard Operating Procedures, and a comprehensive spectrum
of Validation Protocols and preapproval checklists covering development,
scale-up, optimization, pivotal lots, end process validation, commercial
production and process engineering.
Available on CD ROM or in print for immediate in-house use. Guidelines
provided on how to convert development SOPs and PAIs into your own customised
research-based-development system that meet all international regulatory
guides, guidelines and regulatory requirements.
e-SOPs can be utilized to meet your development units own in-house
needs. Designed for Generic and NDA use.
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 OGD 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 ANDA and EC Development and filing in the most cost effective
with diagrams, graphs, tables in b/w & color.
| Handbook Series | Journal
Index | Specialized Journals