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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

Compulsary reading for our R&D, QA 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 10 -2010
H/B Vol 11 -2011
H/B Vol 12 -2012
H/B Vol 13-2013
H/B Vol 14-2014
H/B Vol 15-2015
H/B Vol 16-2016
H/B Vol 17-2017
H/B Vol 18-2018
H/B Vol 19-2019
New Edition Annually

Handbook Generic Development
Sterile Eye Preparations
A Two Part Development Handbook

Locum International Press

Volume 08 P1 - (Complete Handbook in Two Parts)
of the 24 Volume Drug Development Series

This Handbook volume provide extensive and comprehensive development, pre and final formulation, scale-up, process qualification; pivotal to final validation of US and EU commercial batches; Analytical development, analytical methodology, analytical cleaning and process validation 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 and formulation know-how technology. An absolute must have for today's ophthalmic manufacturers.

Covering all the major ophthalmic preservative and excipient systems used today as well as the critical buffer systems, viscosity-hydrogel systems and the advanced use of co-solvents in water-insoluble actives (prostaglandin's antagonists etc) for the preparation of aqueous based ophthalmic solutions (not as suspensions).

Every form (of solutions, suspensions, drops, gels and emulsion) and all the marketed actives and current ophthalmic eye excipients used today are thoroughly discussed, tabulated, reviewed and evaluated in both development and regulatory detail including 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.

An extensively comprehensive and authoritative handbook, reference work, formula, process research and development manual of unparallel quality and technical industrial know-how.

Containing rarely understood key documentation and US/EU development regulatory and technical know-how that is essential for a successful review for a product approval, saving research and development queue-time and money.

Essential development know-how on ophthalmic preparations for both professional innovative and generic ophthalmic drug developers to understand the practical nuts-and-bolts on generic ophthalmic development with a high-tech detailed EU/ANDA formulations and commercial processes currently available on the worlds markets.

This comprehensive and unique Handbook of Pharmaceutical Generic Development is a practical hand-on authoritative work book covering from early development to final end-validation modules of CTD/ANDA/EU sections/modules for Sterile Eye Preparations, highlighting all marketed ophthalmic drops, gels, solutions and suspensions including key eye-nose, eye-ear and eye-nose-ear formulations.

Promotes the development and sharing of practical drug development knowledge and sterile practice technology by significant contributions from agency and industry experts alike.

Complete Volume 1995+ pp for Part 1 and 2 fully illustrated with diagrams, Flow charts, formulation tables, graphs, fishbone diagrams, side-by-side comparisons, tables in b/w & color. Available in print (spiral soft cover) or via digital CD or online drop box (large international multi-users require electronic user license)
. Split volume attract a 25% handling and broken volume charge to split the two part volume.

ISBN: 0793-8701 / 0793-8705

All air shipping is 100% insured for loss or replacement. Shipping rates are:
| Standard | Priority | Expedited.|

Price: Locum International Catalog




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