Available: Print
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
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Handbook Generic Development
SOPs
& 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
validation.
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
way.
Fully
illustrated
with diagrams, graphs, tables in b/w & color.
ISSN: 0793-7859
Price: Locum
International Catalog
All air shipping is 100% insured for loss or replacement. Shipping rates
are
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