Available: Print

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
Vol, Edition # and Pub. Year.

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
H/B Vol 8/Ed 21 - 2021
H/B Vol 8/Ed 22 - 2022
H/B Vol 8/Ed 23 - 2023
H/B Vol 8/Ed 24 - 2024


New Edition Annually.

Locum Publishers Clients
(Handbooks and Journals
.

Handbook Generic Development
Sterile Eye Preparations
A Two Part Development To Final Production Handbook

Locum International Press

Volume 8 P1 - (Complete Handbook in Two Parts)
of the 24 Volume Drug Development Series

This annually updated 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 developers and manufacturers.

SCOPE

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 (prepared as 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.

SEAMLESS INTEGRATION
An Essential Reference for Development Pharmacists, R&D Chemists, QA/QC and Regulatory personnel. Each and every document, protocol and procedure in Part I + II is expertly referenced to the appropriate module number in the CTD/e-CTD system thus providing a fully seamless and effortless integration into either US, EU, Japan and Asian application files and dossiers. All IAGIM technology is purposely and uniquely dove-tailed in regulatory drug product applications -worldwide appliations made simple and precise. An extensively comprehensive and authoritative handbook, reference work, formula, process research and development manual of unparallel quality and state-of-the-art technical industrial know-how.

KEY DOCUMENTATION

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.

INNOVATIVE & GENERIC

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.

DOSAGE FORMS

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/e-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

About Us
Locum International Press are one of the world leading scientific R&D publishers offering an exceptional range of peer reviewed journals, handbooks, book databases and publishing services to the pharmaceutical science community. We also offer a large and comprehensive range of product specific generic handbooks to the pharmaceutical generic drug and innovative drug R&D community.

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

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