Clinical Pharmacology and Pharmacometric Support

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.

Highlights of Prescribing Information


Population Pharmacokinetics of Rabeprazole and Dosing Recommendations for the Treatment of Gastroesophageal Reflux Disease in Children Aged 1–11 Years

Sarah C. McLeay, Bruce Green, William Treem, An Thyssen, Erik Mannaert, Holly Kimko


Population pharmacokinetics of etravirine in HIV-1-infected, treatment-experienced children and adolescents (6 to< 18 years)

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


Impact of Concomitant Antiretrovirals, and CYP2C9 and CYP2C19 Polymorphisms on the Pharmacokinetics of Etravirine


 

Population Pharmacokinetics of Rabeprazole and Dosing Recommendations for the Treatment of Gastroesophageal Reflux Disease in Children Aged 1–11 Years

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.

 

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