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International Journal
of Generic Drugs
ISSN 0793-694X

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International .Journal of :
Generic Drugs
Drug Development
Drug R&D
Drug Formulation
Generic Formula & Processes
Drug cGMP
Drug Process Validation

Generic Registration

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Journal TOC
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Call for Papers
Vol.1 1997
Vol.1 1998
Vol.2 1999
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Vol.13/14 2010/2011
Vol.15/16 2012/2013
Vol.17/18 2014/2015
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International Journal of Generic Drugs
International Journal Series
ISSN 0793-694X

Vol. 2 - Table of Contents
Number 01 - 08

Table of Contents
Issue Number 01

COMMENT
Part FIVE of an Eight Part Series on Controlled Release Oral Tabs. A detailed model application of a tablet presentation for a US Abbreviated New Drug Application

R&D STRATEGY

A R&D Strategy detailing a well defined research and development management program is geared to become the make or break tool for the drug development industry.

ANDA Series
Explanation on how the overall OGD ANDA series is presented in the International Journal Issues.

ANDA Series
The Complete Model ANDA for Controlled Release Oral Tablet / Caplets is presented in sections in the highlighted consecutively issues.

ANDA Section XII
Describing the Manufacturing Process of the executed batch in terms of the underlying manufacturing and control parameters.
Control Procedures
Master Formula Details/layout
Master Manufacturing Records
Manufacturing Flow Chart
Manufacturing Specifications
Hardness Qualification
Packaging & Disbursements.

Dissolution Validation
Validating Dissolution methodology for a suspended oral dosage form

Drugs Off-Patent
R&D Pipeline Strategy for the coming millennium highlighting Major Drugs Off-Patent


Table of Contents - Vol. 2 Number 02

COMMENT
Part Six of an Eight Part Series on Controlled Release Oral Tabs. A detailed model application of a CR Tablet presentation for a US Abbreviated New Drug Application

ANDA Section 14, 15 & 16
Overview - New Packaging Guidelines spell out all the requirements for the major dosage forms. FDA's guideline for container closure systems is a forty eight page 'Guidance for industry' on container-closure systems used for drug packaging.

PACKAGING COMPONENTS
Check list form A to Z on vendor and in-house documentation requirements for the packaging section of an ANDA.

ANDA SECTION 15
Simple ANDA Section 15 Data requirements for the Finished Dosage Form.

CR DEVELOPMENT
Developing Controlled Release Solid Oral Dosage Forms (CR/MR).

Modified Release - Developing the CR Formula
Overview of product development stages for a CR generic - Tabulated and comprehensive.

PRODUCT DEVELOPMENT GUIDE
CONTROLLED RELEASE DOSAGE FORMS


Table of Contents - Vol. 2 Number 03

COMMENT
Part Seven of an Eight Part Series on Controlled Release Oral Tabs. A detailed model application of a CR Tablet presentation for a US Abbreviated New Drug Application

ANDA Series
Explanation on how the overall OGD ANDA series is presented in the International Journal Issues.
The Complete Model ANDA for Controlled Release Oral Tablet / Caplets is presented in sections in the highlighted consecutively issues.

IMPURITIES
New draft active drug substance guidance provide, recommendations for including information in abbreviated new drug applications (ANDAs) and supporting drug master files (DMFs) on the identification and qualification of impurities in drug substances produced by chemical syntheses for both monograph and non-monograph drug substances..

Modified Release
Swelling Matrix Dosage Form - Choice of releasing controlling excipients

ANDA
Analytical Testing & Validation Protocol

ANDA
Stability of Drug Substances and Drug Product .

PAC-ATLS GUIDELINE:
Post-approval Changes in Analytical Testing Laboratory Sites - Draft Guidance for Industry


Table of Contents - Vol. 2 Number 04

COMMENT
Final Part of the Eight Part Series on Controlled Release Oral Tabs. A detailed model application of a CR Tablet presentation for a US Abbreviated New Drug Application

ANDA Section 18
Explanation on Section 18 by way of an updated model example.

ANDA Section 19
Explanation on Section 19 by way of a model example.

ANDA SECTION 20
Explanation on Section 20 by way of a model example.

ANDA SECTION 21
Explanation on how to use Section 21 by way of a model example.

On Generic Bioequivalence…
Pharmaceutical generic bioequivalence VS the Reference Listed Drug. Impact of IBE / PBE and ABE; Prescription Switchability terms explained.

Dissolution Similarity Test
Pharmaceutical Classification and Similarity Test Equation

FDA Stability Guidance
Review of the proposed June 1998 FDA draft stability Guidance to Industry.

STABILITY SAMPLING SOP:
Sampling Procedures on Solid Dosage Forms as applicable to the New Guidelines


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