Handbook Generic Development
Sterile Eye and Nose Preparations
A Two Part Development Handbook

Locum International Press

Volume 09 (Complete Handbook in Two Parts)
of the 24 Volume Drug Development Series.

This lastest two part authoritative Handbook of Pharmaceutical Generic Development is a practical hands-on, technical research and development easily to read and understand reference book packed with all the needed formula, specifications and manufacturing procedures, batch-lot qualification, scale-up stages to full sized batches with all current process specifications and validation protocols and procedures covering the A-Z preparation steps for the creation of profesional CTD/ANDA product sections for the manufacture of Sterile Eye & Nose Preparations (ophthalmic drops, solutions and suspensions and sterile nasal solutions, sprays and drops.)

Extensive coverage of sterile validation protocols from washing machines, steam sterilizers and lyophilizers. Updated current advances and developments in pharmaceutical, formulations, legal and regulatory product development approaches by industry and agency experts that is needed to know and understand for the development of these specialized sterile dosage forms.

Details advanced formula development and sterile process validation, including validation protocols and checklists of all the major sterile cleaning equipment and manufacturing processes, HVAC utilities and appropriate sterilization procedures and equipment

Includes the required pharmaceutical legal and regulatory CTD/ANDA module development know-how providing essential development technology on Sterile Eye & Sterile Nose Preparations for professional top level developers to understand the nuts-and-bolts on Sterile Generic Q1Q2 FDA mandated development in order to produce high-tech detailed CTD/ANDAs. Explains in precise details the FDA inactive ingredient database (FDA-IID) on how to use this formulation database in sterile Eye & Sterile Nose formulations/preparations. Including key Tips and Traps to avoid. Highlights design and formulation concepts using the innovator's RLD via simple reverse-engeneering procedures and challenge tests.

Provides full production formulas and actual manufacturing process documentation for both ophthalmic and nasal drops and solutions of top branded popular commercial products such as Timolol, Naphazoline, Tetrahydrozoline (Visine), Dorzolamide, Zylometazoline nasal drops and Flunisolide nasal solution.

Every document that goes into a CTD/ANDA product development is explained in detailed, clear precise English with FDA prior-approved document examples on how to structure and layout the key documentation - and what to include and what to omit.

Complete Volume in two parts 1990-2000 pp. Part 1 and 2 fully illustrated and annotated with diagrams, flow charts, formula, graphs, spectra, side-by-side comparisons, tables in b/w & color. Available in print (spiral soft cover opens flat) or via digital CD (multi-users require additinal optional license). Split volume attract a 25% handling and broken volume charge to split the two part volume.

ISSN: 0793 7601 / 0793-761X

Price: Locum International Catalog

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