Areas of expertise we can assist you with include:
- Support with studies from synopsis/protocol development through to Clinical Study Report (CSR)
- Guidance in the design, planning, execution, analysis and interpretation of in vivo and in vitro ADME and PK studies
- PK parameter interpretation and study guidance for clinical studies, including First-in-Human (FIH), Single Ascending Dose (SAD), Multiple Ascending Dose (MAD), Food Effect, Human Mass Balance and Formulation Selection studies
- Review and interpretation of ongoing DMPK discovery & development programmes
- Understanding of bioanalytical requirements for the support of regulatory standard preclinical and clinical sample analysis
- Design of DMPK development packages to support global regulatory submissions
- Review of DMPK sections of key regulatory documents such as IB's and IND’s for new drug applications
- Management and co-ordination of DMPK services to CRO’s including subsequent review of CRO reports
- PK training and mentoring, provided by a qualified educator