Clinical Pharmacology Strategy and Writing

Clinical Pharmacology Strategy and Writing

• Gap analyses and mitigation strategy
• Due diligence (asset evaluation)
• Clinical pharmacology plans
• Clinical study designs
• Clinical Study protocols (in full or in part)
• Clinical Study reports and/or standalone PK report
• Regulation document preparations (PK/PD)
• Clinical development plans (in full or in part) and reviews
• Responses to regulatory questions (in full or in part) and reviews
• Comparator PK/PD data analyses
• Regulatory meeting representations
• Dose rationale and justification
• PK/PD design in the study protocols
• Inclusion/exclusion criteria
• Assessment of Drug-drug interaction (DDI) potential
• Drug-drug interaction (DDI) waiver justifications
• Assessment of risk for QT prolongation potential
• Thorough QT (TQT) waiver justification
• Pediatric drug development and dose determination