ER Guidance

4/7/97


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Table of Contents

ER Guidance

Guidance for Industry Extended Release Oral Dosage Forms

Topics

Evolution of IVIVC Activity

Basic Concept

What’s in the Guidance?

General Considerations

Developing an IVIVC

Alter dissolution conditions

Dosage Form Properties

Developing an IVIVC most commonly seen process

Development dissolution data

Development

Development bioavailability data

Development fraction absorbed

Development fraction absorbed/dissolved

IVIVC 3 formulations

IVIVC 3 formulations

IVIVC slow

IVIVC medium

IVIVC fast

IVIVC slow and medium

Development Checklist

Evaluation of Predictability

Estimation of prediction error internally

Estimation of prediction error externally

Additional test data sets decreasing order of preference

Overall IVIVC Process

Methods for Evaluation of Predictability

Internal Predictability

Internal Predictability

Evaluation of Predictability internal

External Predictability

External Predictability

Evaluation of Predictability external

Summary

Acknowledgements

Author: Hank Malinowski

Email: malinowski@cder.fda.gov

Home Page: http://www.fda.gov/cder/dpe1.htm

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