Embedded Files
The FDA has launched Project Optimus for oncology drug products
Regulatory Strategy
Regulatory Strategy
Approval Route & Lifecycle Management
Approval Route & Lifecycle Management
Strategic Planning for Necessary Studies in Clinical Development
Strategic Planning for Necessary Studies in Clinical Development
Post-Marketing Studies for RWE
Post-Marketing Studies for RWE
Regulatory Meetings
Regulatory Meetings
INTERACT (pre-pre-IND) Meeting
INTERACT (pre-pre-IND) Meeting
Pre-IND Meeting
Pre-IND Meeting
IND Filing (Safety IND)
IND Filing (Safety IND)
End-of-Phase 2 Meeting
End-of-Phase 2 Meeting
Pre-NDA/BLA Meeting
Pre-NDA/BLA Meeting
Type A/B/C/D Meeting
Type A/B/C/D Meeting
Model-Informed Drug Development
Model-Informed Drug Development
FIH Dose Selection
FIH Dose Selection
PBPK Modeling for Effects of Extrinsic/Intrinsic Factors on PK
PBPK Modeling for Effects of Extrinsic/Intrinsic Factors on PK
PBPK Modeling for Pediatric Population
PBPK Modeling for Pediatric Population
Population PKPD Modeling & Simulation
Population PKPD Modeling & Simulation
Exposure-Response Analysis for Dose Optimization
Exposure-Response Analysis for Dose Optimization
Modeling and Simulation for Prediction of Clinical Performance
Modeling and Simulation for Prediction of Clinical Performance
Meta-Analysis for Go/No-Go Decision Making
Meta-Analysis for Go/No-Go Decision Making
CMC Regulatory Support
CMC Regulatory Support
Assess CMC Development Strategy
Assess CMC Development Strategy
Review eCTD Module3
Review eCTD Module3
Review Part in IB (Investigator's Brochure) and Briefing Documents
Review Part in IB (Investigator's Brochure) and Briefing Documents
Mock GMP Audits
Mock GMP Audits
Resolultion of Regulatory Issues
Resolultion of Regulatory Issues
Clinical Data Management
Clinical Data Management
Clinical Pharmacology
Clinical Pharmacology
FIH Dose Selection
FIH Dose Selection
Phase 1 Study Design
Phase 1 Study Design
ADME Study Design
ADME Study Design
Strategies to Address Extrinsic (DDI, Food)/Intrinsic (Hepatic, Renal) Effects on PK
Strategies to Address Extrinsic (DDI, Food)/Intrinsic (Hepatic, Renal) Effects on PK
Pediatric Study Plan
Pediatric Study Plan
Concentration-QT (CQT) Assessment
Concentration-QT (CQT) Assessment
Thorough QT (TQT) Study Design
Thorough QT (TQT) Study Design
BE/BA Study Design
BE/BA Study Design
Dose Escalation Study Design
Dose Escalation Study Design
Non-Compartmental Analysis for Phase 1 PK Data
Non-Compartmental Analysis for Phase 1 PK Data
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