Handbook Generic Development
Sterile Eye Preparations
Two Part Development To Final Production Handbook
Volume 8 PII
(Complete Handbook in Two Parts)
of the 24 Volume Drug Development Series
This latest annually udated 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
Table of Contents for both US and EU e-CTD 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 of the volume details pharmaceutical development, legal and regulatory
generic development, SOPs, tecjnical know-how and validation of all CTD/e-CTD
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.
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.
Development pharmacists, R&D chemists and scientists in pharmaceutical
companies and university departments, in the areas of innovative, new
drugs and generic drug development, QA / QC. validation and regulatory
Complete Volume in two parts 1990-2000 pp.
Part 1 & 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.
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
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