HANDBOOK OF
PHARMACEUTICAL
GENERIC DEVELOPMENT

ORAL TABLETS
Controlled Release
Extended & Delayed

Volume in Two Parts

Extended & Delayed Solid Oral Dosage Forms

The Authoritative Drug Development
Reference Works

SPECIAL FEATURES

Suitable for US and EU/Asian Generic Development. - Covers A to Z development know-how from pre-formulation of Generic CTD to final generic large scale process validation - detailing more than 150 key development steps from pre-formulation to scale-up and commercial process validation.
Over 30 developmental checklists on the key development issues that agencies routinely address during dossier/file review.
Each checklist dovetails with a guideline on a Standard Operating Procedure with real life examples from A (actives - V (validation)
More than 50 real life SOP examples

Each document required to build a successful CTD/Generic/Dossier/ANDA (with side-by-side explanation notes and summaries.

Clarifying each and every scientific document required for US and EU development from initial pre-formulation development to scale-up to qualification to production to commercial validation.
Includes analytical methodology and validation as well as cleaning procedures and cleaning validation required to build a successful US/EU Dossier (with side-by-side explanation notes and summaries presented as a two part volume with detailed annotations, tabulations,checklists, SOPs and flowcharts.

This authoritative 8th edition (current 2008) Handbook Series is devoted to Generic Drug Development from pre-formulation to commercial batch production and final regulatory submission. Written for Industry in two easy-to-use complementary handbooks, with a unique modular format and as-you-submit data layout.

Describes over 150 key development steps from pre-fomulation to commercial validation. Each topic is a development stage and is supplemented with unique flowcharts, checklists, tables, graphs and product specific key Development SOPs. Contains actual working end product validation and full CMC of leading CR commercial products

Complete development CTD/CMC with development and expert reports plus major commercial CR formulation and mfg. processes. Explanation notes and dovetails side-by-side with current guidelines and advanced development technology continuing from Part One.

EU section is a development CTD with Development and Expert Report containing detailed explanation notes using expected agency terminology.

HANDBOOK OF PHARMACEUTICAL
GENERIC DEVELOPMENT
TABLETS CR

Who this book is for
The Handbook of Pharmaceutical Generic Development is an essential workbook for the full CTD/CMC and RA sections and provides Development, Pre-Formulation, Formulation, Process Qualification, Scale-up, Pivotal, Stability Batches, end-process validation, full size commercial validation protocols for largest and smallest batch lots
Documentation and Regulatory know-how that is essential for a successful review for a generic US/EU approval, saving research and queue-time and up to 50% of development work and dollars.

Essential reading for Development Pharmacists, Project managers, R&D Chemists, QA and Regulatory personnel.

Allows management to understand the nuts and bolts on CTD/Generic filing in the most cost effective way.
Ideal in-house training material for pharmaceutical graduates.

Twelve volumes from tablets to topical available. New editions annually maintain the Handbook Series as current and authoritative.
24 volume Series ISSN 0793-7407

HANDBOOK OF PHARMACEUTICAL
GENERIC DEVELOPMENT


SEMISOLIDS
TOPICAL


Volume in Two Parts



A Handbook for Generic Drug Development


A Locum House Publication

Covers A to Z development know-how from pre-formulation of Generic CTD to final generic filing - detailing more than 150 key development steps from pre-formulation to scale-up and process validation.
Over 30 developmental checklists on the key generic issues that agencies routinely address during dossier/file review.
Each checklist dovetails with a guideline on a Standard Operating Procedure with real life examples from A (actives - V (validation)
More than 50 real life SOP examples

Each document required to build a successful CTD/Generic/Dossier/ANDA (with side-by-side explanation notes and summaries.

Clarifying each and every scientific document required for US and EU development from initial pre-formulation development to scale-up to qualification to production to commercial validation including analytical methodology and validation as well as cleaning procedures and cleaning validation required to build a successful US/EU Dossier (with side-by-side explanation notes and summaries presented in two user friendly parts with detailed annotations, protocols, tabulations,checklists, SOPs and flowcharts.

HANDBOOK OF
PHARMACEUTICAL
GENERIC DEVELOPMENT
Semisolids

WHO IS THIS BOOK FOR:
The Handbook of Pharmaceutical Generic Development is an authoritative workbook for the full development of the CMC and RA sections on an US ANDA.
H/Books provide Development, Formulation, Process Qualification, Scale-up, Pivotal, Cleaning and Commercial Validation, Key Documentation, Pre-approval requirements and Regulatory know-how that is essential for a successful review for an FDA & EU approval - saving queue-time and money.

Essential reading for Development Pharmacists R&D Chemists, QA/QC and Regulatory personnel
Allows Senior management to understand the nuts and bolts of Generic CTD/Generic/ANDA filing in the most cost effective way.