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

 

Clinical pharmacology presents many challenges along the development milestones to successful market approval. A streamlined clinical pharmacology strategy based on your drug’s class-specific properties is essential for efficiency and cost savings. XP Parma Consulting has intensive experience setting the strategy roadmap and helping you advance your drug development milestones. Our subject matter experts prepare regulatory documents specific to clinical pharmacology, modeling, and simulation (M&S), and dose justification across the development spectrum from pre-IND to registration. We deliver high-quality written deliverables and submission-ready documents to facilitate drug development.