Available: Print or CD
The world's most definitive & authoritative
current generic drug development series available.
"No development unit should be without it -Pliva"
Handbook Generic Development
Sterile Eye Preparations
A
Two Part Development Handbook
Locum International Press
Volume 08
(Complete Handbook in Two Parts)
of the 24 Volume Drug Development Series.
This lastest authoritative Handbook of Pharmaceutical Generic Development
is a practical hand-on workbook covering the preparation for the full
twenty two ANDA sections of Sterile Eye Preparations (ophthalmic drops,
solutions and suspensions). Extensive coverage of sterile validation protocols
from washing machines steam sterilizers and lyophilizers. Current advances
in pharmaceutical, formulations, legal and regulatory development approaches
by industry and agency experts. Table of Contents for both US and EU eCTD
and CTD modules.
Part Two Detailed pharmaceutical
legal and regulatory ANDA Development of all Sections provide essential
development know-how on Sterile Eye Preparations
for professional developers to understand the nuts-and-bolts on Sterile
Generic development with a high-tech detailed working model ANDA.
Every document that does into an ANDA is explained in clear English
with a FDA prior approved example.
Complete
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
flat) or via digital CD (multi-users require additinal optional license)
ISSN:
0793 7601 / 0793-761X
All air shipping is 100%
insured for loss or replacement. Shipping rates
are:
| Standard | Priority | Expedited.|
Price:
Locum
International Catalog
 |
 |
| Ready-To-Go Link | Handbook Series | Journal Index | Specialized Journals |
