Analgesic Drug Development for Neuropathic Pain Methodologic Issues

5/17/02


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Table of Contents

Analgesic Drug Development for Neuropathic Pain Methodologic Issues

Analgesic Drug Development: Regulatory Framework

Supportive Guidelines

Neuropathic Pain What is the regulatory framework for drug approval?

Broad Indication vs. Multiple Sub-indications: Pros and Con

Making a Case for a Broad Neuropathic Pain Claims Structure

Taxonomy

Peripheral Neuropathic Pain

Will we (ever) get drugs approved for neuropathic pain if there is a requirement for replicate evidence in each painful neuropathy?

RCT’s in Cancer Pain Pain Characteristics

Is there a Wide Divergence in the Efficacy Response to Various Pharmacologic Agents in Painful Neuropathies?

Recent Retrospective Evaluation

PPT Slide

PPT Slide

What to Measure in Neuropathic Pain Studies?

Pain Descriptors

Pain Characteristics

Pharmacologic Response in PHN

What else to measure?

Core Development Program [505 (b) (1)] for Neuropathic Pain (Broad Indication)

Analgesic Drug Development for Neuropathic Pain Key Methodologic Issues

Author: Najib Babul, PharmD