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
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Author: Najib Babul, PharmD
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