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

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