Consulting Services
Optimise and accelerate your drug development program
Model Answers offers a range of consulting services to optimise and accelerate your drug development program, these include:
- Design/timing and interpretation of clinical pharmacology studies
- Assisting with the clinical pharmacology section of regulatory documents
- Regulatory questions and interactions
- Drug interaction assessment and strategy
Submission & Filing
Access our extensive regulatory experience
Modelling and simulation is an integral part of any new drug application (NDA). Both the FDA, EMA and the PMDA have continued to support these approaches with the release of specific guidance documents and publications.
The results of pharmacometric analyses are used to support both dose selection decisions and the dosing recommendations in the drug label. Model Answers has supported numerous interactions with regulatory authorities as well as successful NDAs:
Example of how population PK can be used in the label:
Examples of successful approvals supported by Model Answers:
Sarah C. McLeay, Bruce Green, William Treem, An Thyssen, Erik Mannaert, Holly Kimko
Thomas N Kakuda, Bruce Green, Glynn Morrish, Anne Brochot, Steven Nijs, Peter Vis
Population Pharmacokinetics of Bedaquiline (TMC207), a Novel Antituberculosis Drug
Sarah C. McLeay, Peter Vis, Rolf P. G. van Heeswijk and Bruce Green
Using population PK to evaluate drug interaction potential:
Model Answers supports paediatric dose selection and trial design:
Sarah C. McLeay, Bruce Green, William Treem, An Thyssen, Erik Mannaert, Holly Kimko
The need for modelling and simulation to design clinical investigations in children.
Jadhav PR1, Kern SE.
Contact Us to find out how Model Answers can help you plan the optimal use of PK-PD analysis, modelling and simulation in the drug development life cycle.