RU Drug Regulatory Affairs Pharmaceutical Sciences Paper

Final ProjectLopa Bakrania
Regulatory Affairs
Dr. Lopa Bakrania
Pre-Clinical
Discovery
Phase 1
Phase 2
Phase 3
Launch
Commercialization
Target
Identification
Lead Generation
Optimization
Safety Studies
First Human Dose
Development
Determine safety
Establish dose
File IND/CTA
Side Effects
Effectiveness
Process Scale-up
Robustness
Pivotal Trial
Validation
Edge of failure
Design Space
Market Approval
Patients
Continuous
Improvement
Regulatory Affairs
Dr. Lopa Bakrania
Prepare IND: CMC Section
Metopimazine is a dopamine receptor antagonist that has been used for the prevention and
treatment of nausea and vomiting.
Write the CMC section for an initial investigation application (IND) to the FDA requesting to
start a Phase I clinical study in the US for three formulations.
Assume an MDD of 50 mg/day
Follow the template provided.
Regulatory Affairs
Dr. Lopa Bakrania
Drug Substance Synthesis
Regulatory Affairs
Dr. Lopa Bakrania
Drug Substance Synthesis
•
•
•
Use the synthetic strategy for Metopimazine shown in the previous slide for the CMC filing
For the solvents focus on the last two steps.
Include the batch data and impurities provided in the subsequent slides in the IND.
HO
O
O
H
N
S
O
H3C
O
N
S
H3C
S
Impurity A
S
Impurity B
Regulatory Affairs
Dr. Lopa Bakrania
Analytical Data Drug Substance Batches
Batch #
AA1
Endotoxin Use of Batch
EU/mg active
Appearance
Color
Identity by
Raman
Assay (%)
Water (%)
Powder
Yellow
Complies
93
6.6