Consultancy Services
DMPK
Clinical Pharmacology
Clinical Pharmacology
- DMPK review of ongoing discovery & development programmes
- Interpreting and integrating DMPK data in drug discovery & development programmes
- Specialist DMPK expertise in Inhaled projects
- Guidance designing and conducting ADME, PK, TK and PK/PD studies
- Application of PK and PBPK modelling directed at advising on prediction of human PK and dose
- Interpretation of preclinical data as a guide for next steps to support First in Human studies
- Broad knowledge of DMPK development packages to support global regulatory submissions
- Drafting DMPK written interactions with global regulatory agencies and authorship of DMPK sections of key regulatory documents such as IBs, INDs, Briefing Books for scientific advice and CTDs for new drug applications
- Management and co-ordination of DMPK services to CRO’s and review of CRO reports
- Knowledge of bioanalytical requirements to support regulatory standard preclinical and clinical sample analysis
- Review and unbiased critique of research proposals
- In-licensing/outsourcing and due diligence activities
Clinical Pharmacology
Clinical Pharmacology
Clinical Pharmacology
- Formulation of program specific clinical pharmacology development plans
- Specialist clinical pharmacology expertise in Inhaled projects
- Study guidance for: First-in-Human (FIH); Single Ascending Dose (SAD); Multiple Ascending Dose (MAD); Food Effect; Drug-Drug Interaction (DDI); Hepatic Impairment; Renal Impairment; Thorough QT (TQT); Human Mass Balance; Paediatrics; Bioequivalence; Formulation
- Synopsis/Protocol development & Clinical Study Report (CSR)
- Guidance as to the application of PK and PBPK modelling for optimal clinical study design; assisting in dose selection and informing product labelling
- Interpretation of industry guidance documents for individual clinical pharmacology development programs
- Broad knowledge of clinical pharmacology development packages to support global regulatory submissions
- Drafting clinical pharmacology written interactions with global regulatory agencies and authorship of clinical pharmacology sections of key regulatory documents such as IBs, INDs, Briefing Books for scientific advice and CTDs for new drug applications
- In-licensing/outsourcing and due diligence activities