By far the world's most definitive & authoritative current ophthalmic
drug development volume available.
"No development unit should be without it" - Pliva
We are sorry that this world
leader in ophthalmic R&D
development was not in print 15 years ago for our staff - ALCON
An amazing publication in absolute ophthalmic excellence
- Merck Co Inc NY USA
Compulsory reading for our
R&D, QA QC RA and formulation/prod units - Bausch & Lomb UK
Thank you for Vol 8, PI+PII absolutely
state-of-the art in every shape and form - Merck Sharp & Dohme
Our company purchased the entire 24 vol Handbook Series
and we find Vol 8 absolutely outstanding - it contains so much detail
- Pliva Pharma
By far the best R&D formulation book in our large library - Allergan
Your handbook taught us today's ophthalmic sterile technology - Novartis
Money very well spent on your ophthalmic Hand-book, thank you - UCB
A truly great publication - and a best seller, a flagship in your series-
LOCUM INT. PRESS
Vol, Edition # and Pub. Year.
H/B Vol 8/Ed 14 - 2014
H/B Vol 8/Ed 15 - 2015
H/B Vol 8/Ed 16 - 2016
H/B Vol 8/Ed 17 - 2017
H/B Vol 8/Ed 18 - 2018
H/B Vol 8/Ed 19 - 2019
H/B Vol 8/Ed 20 - 2020
New Edition Annually
Handbook Generic Development
Sterile Eye and Nose Preparations
Two Part Development To Final Production Handbook
Locum International Press
(Complete Handbook in Two Parts)
of the 24 Volume Drug Development Series.
This lastest two part authoritative Handbook of Pharmaceutical
Generic Development is a practical hands-on workbook packed with all the
formula specifications and manufacturing procedures, batch-lot qualification,
scale-up stages to full sized batches with all necessary process specifications
and validation protocols and procedures covering the A-Z preparation steps
for the creation of profesional CTD/ANDA sections for the manufacture
of Sterile Eye & Nose Preparations (ophthalmic drops, solutions and
suspensions and sterile nasal solutions, sprays and drops.)
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 that is needed to know for the development of these
specialized sterile dosage forms.
Details advanced formula development and sterile process validation,
including validation protocols and checklists of all the major sterile
cleaning equipment and manufacturing processes, HVAC utilities and appropriate
sterilization procedures and equipment
Includes the required pharmaceutical legal and regulatory CTD/ANDA module
development know-how providing essential development technology on Sterile
Eye & Sterile Nose Preparations for professional top level
developers to understand the nuts-and-bolts on Sterile Generic Q1Q2 FDA
mandated development in order to produce high-tech detailed CTD/ANDAs.
Explains in precise details the FDA inactive ingredient database on how
to use this formulation database in sterile Eye
& Sterile Nose formulations. Including key Tips and Traps to
avoid. Highlights design and formulation concepts using the innovator's
RLD via simple reverse-engeneering procedures and challenge tests.
Provides full production formulas and actual manufacturing process documentation
for both ophthalmic and nasal drops and solutions of top branded popular
commercial products such as Timolol, Naphazoline, Tetrahydrozoline (Visine),
Dorzolamide, Zylometazoline nasal drops and Flunisolide nasal solution.
Every document that goes into a CTD/ANDA product is explained in clear
precise English incorporating FDA prior-approved document examples on
how to structure the necessary documentation - and what to include and
what to omit.
Volume in two parts 1990-2000 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).
Split volume attract a 25% handling and broken volume charge to split
the two part volume.
All air shipping is 100% insured door-to-door for loss or replacement.
Shipping rates are: | Standard
| Priority | Expedited.|
Price go to:
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