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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