LOCUM INT. PRESS
Vol, Edition # and Pub. Year.
H/B Vol 19/Ed 19 - 2019
H/B Vol 19/Ed 20 - 2020
H/B Vol 19/Ed 21 - 2021
H/B Vol 19/Ed 22 - 2022
H/B Vol 19/Ed 23 - 2023
H/B Vol 19/Ed 24 - 2024
H/B Vol 19/Ed 25 - 2025
H/B Vol 19/Ed 26 - 2026
New Updated Edition Annually
Handbook Generic Development
& PAIs / Protocols / Checklists
Locum International Press.
Volume 19 (A Four Part Volume) of the
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 edited 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
Eessential 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.
All air shipping is 100% insured for loss or replacement. Shipping rates
| Standard | Priority | Expedited.
| Handbook Series | Journal
Index | Specialized Journals