Table of Contents
Analgesic Drug Development for Neuropathic Pain Methodologic Issues
Analgesic Drug Development: Regulatory Framework
Neuropathic PainWhat 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
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 Responseto Various Pharmacologic Agents in Painful Neuropathies?
Recent Retrospective Evaluation
What to Measure in Neuropathic Pain Studies?
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