Our group of experts can help you establish and implement a development  plan, focusing on the mechanism of action, pharmacokinetics and  pharmacodynamics of the drug or biotechnology compound being developed.   The key focus is to determine the ideal translational medicine program  that will ultimately support the approved indication in the targeted  patient population.

• INDs/NDAs
• FDA Briefing Documents
• Clinical Study Reports (CSRs)
• Nonclinical Reports
• Validation Reports
• Investigator Brochures (IB)
• Orphan Drug Applications
• Protocols/Amendments
• Expert Reports
• Justification White Papers
• Patient Safety Narratives
• FDA White Papers
• Safety Updates 

DUCK FLATS Pharma provides our clients with a variety of PK + PD analyses to fit their needs. We can help design the right analyses to achieve your program goals.

Our List of Analyses Include:

• Modeling and Simulation
• PK/PD
• TK
• POP PK and POP PK/PD (with intensive datasets)
• Clinical Trial Simulations
• IV/IVC
• First-in-man Calculations
• Bridging Nonclinical to Clinical, and Biomarkers to Clinical Efficacy
• Integrated PK and PK/PD meta-analyses for NDAs

We can develop your strategies for targeted drug development plans specific to the therapeutic indication, and provide guidance for the right group of experiments for both in vitro  and in vivo nonclinical programs (pharmacology, toxicology and nonclinical PK/metabolism/ADME).  Our experts can assist with the determination of optimum bioanalytical development and assist with regulatory submissions (both domestic and international).

With our expertise, we can help you design:

• First-in-human Studies
• PK/PD Studies
• Phase 1 Oncology
• TQT/Cardiac Safety
• PK/Efficacy
• Absolute Bioavailability
• Relative Bioavailability
• Food Interaction
• Special Populations
• Gender Studies
• Renal Impairment/Hepatic Impairment
• Elderly/Pediatric Drug-Drug Interaction
• Pediatric Clinical Trials
• Interaction Studies
• Radiolabeled Metabolism Trials
• Proof-of-Concept Trials in Patients
• Biopharmaceutics Program linked to CMC Development
• Phase 2 Dose-Ranging Programs

• In-licensing/Out-licensing Strategies
• Due-diligence Review
• Regulatory Submission Strategies
• CMS Consultation Services