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Available: Print, Online (Drop box) or CD
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 Limited
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
Ltd
Your handbook taught us today's ophthalmic sterile technology - Novartis
Pharmaceuticals
Money very well spent on your ophthalmic Hand-book, thank you - UCB
Pharma Ltd
A truly great publication - and a best seller, a flagship in your
series- Pharmacia.
LOCUM INT. PRESS
Edition # and Pub. Year.
H/B Vol 09 -2009
H/B Vol 10 -2010
H/B Vol 11 -2011
H/B Vol 12 -2012
H/B Vol 13-2013
New Edition Annually
| |
Handbook Generic Development
Sterile Eye Preparations
A
Two Part Development Handbook
Locum International Press
Volume 08 PII
(Complete Handbook in Two Parts)
of the 24 Volume Drug Development Series.
This latest authoritative Handbook of Pharmaceutical Generic Development
is a practical hand-on workbook covering the total preparation, manufacture
and validation of Sterile Eye Preparations (ophthalmic drops, solutions,
gels, emulsions and suspensions).
Extensive coverage of sterile validation protocols from washing machines
steam sterilizers and lyophilizes. Current advances in pharmaceutical,
formulations, legal and regulatory development approaches by industry
and agency experts. Explaining in simple terms osmolarity, isotonicity,
colligative properties, hydrogels and viscosity agents, co-solvents,
optimum pH for actives and preservatives, buffers systems and buffer
capacity and preservative choice for each individual active/excipient
master formula and tailoring preservative concentration to current product
usage, either chronic, acute and multi product dosing procedures and
patient/consumer use.
Table of Contents for both US and EU eCTD and CTD modules. Covering
the major ophthalmic preservative and excipient systems used today as
well as the critical buffer combinations, viscosity-hydrogel systems
in aqueous eye solutions and occular suspensions and the advanced formulation
use of co-solvents with water-insoluble active materials API's (prostaglandin's
antagonists etc) for the preparation of aqueous based ophthalmic solutions
(not formulated as a suspension).
Part Two details pharmaceutical legal and regulatory generic development
of all modules provide essential development know-how on Sterile
Eye Preparations for professional developers to understand the
nuts-and-bolts on Sterile Generic ophthalmic development.
TOP 120 PRODUCT FORMULAS
Every form (of solutions, suspensions, drops, gels and emulsion) and
all the marketed actives and current ophthalmic eye excipients in use
today are thoroughly discussed, tabulated, reviewed and evaluated in
both development and regulatory detail including ophthalmic preparations
for use in glaucoma, NSAI's, mast cell stabilizers, anti-allergy, ocular
anti-infectives, antibiotics, conjunctivitis, corticocsteriods, midriatics,
anesthetics, anti-inflamatories, ocular lubricants and artificial tears,
among others.
Key documents that goes into an CTD/ANDA are explained in clear English
with a FDA prior approved example covering in excess of 120+ of the
world's top selling and successful ophthalmic solutions (drops and gels),
suspensions and eye emulsions in both multi dose and single dose units.
Every formulation aspect is covered from A to Z in development, scientific
and ophthalmic formulation know-how technology. An absolute 'must-have'
for today's' ophthalmic manufacturers. No developer should be without
this vast technical ophthalmic publication. Updated and expanded annually
with the latest ophthalmic products and formulas.
Complete
Volume in two parts 1990-2000 pp. Part 1 and 2 fully illustrated and
annotated with diagrams, high-tech schematics, fishbone diagrams, flow
charts, formula, graphs, spectra, side-by-side tabulated comparisons,
tables in b/w & color. Available in print (soft, hard, spiral soft
cover opens flat) or via digital online (drop box), CD (large multinational
multi-users require electronic license). Split
volume attract a 25% handling and broken volume charge to split the
two part volume.
ISSN:
0793 7601 / 0793-761X
All air shipping is 100%
insured for loss or replacement. Shipping rates
are:
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Locum
International Catalog
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