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Clinical Pharmacology Services
We implement crucial clinical pharmacology strategies to support your successful drug development programs. The team includes experts in clinical pharmacology and bioanalytical services who have on average >20+ years experience in regulatory agencies, pharma industry, contract research and academia.
- Clinical Pharmacology reviews of drug development program and support development of the clinical pharmacology strategy
- Work in an integrated manner with your team to provide clinical pharmacology representation
- Provide clinical pharmacology support for study design, protocol development and pharmacokinetic (PK) and PK/PD analyses
- Provide clinical pharmacology authorship and support for regulatory filing and interactions
Contact us to find out how PK Consultancy can help facilitate your drug development program
Pharmacokinetic / Toxicokinetics Services
We conduct pharmacokinetic analysis to current industry standards using software commonly accepted by regulatory agencies such as Phoenix WinNonlin. We ensure high quality analyses in a timely manner using our rigorous processes including internal work instructions, checklists, SOPs and peer review.
- Pharmacokinetic Analysis Plans and Tables, Listings, and Figure Shells
- Non Compartmental Analysis
- Interim Study Analysis
- High Level PK Results Summaries
- PK Reporting
- Generation and Review of Tables, Listings, and Figures
Pharmacometrics
We provide population based pharmacokinetic analysis using NONMEM. In addition we are able to generate
- NONMEM datasets, modeling analysis plans (MAP) and reports.
- PK Consultancy provides modeling and simulation to support your development needs, including:
- NONMEM dataset preparation
- Provide guidance on PK sampling during clinical studies in order to support pop PK efforts
- Modeling Analysis Plans
- Modeling Reports
- Modeling and simulation from Phase 1 to post-market
- Allometric scaling
- Selection of dosing regimens
- PK/PD analyses
- Guidance for pediatric drug development
Drug Metabolism and Pharmacokinetics (DMPK) Services
We are able to provide guidance in conduct and interpretation of drug metabolism and pharmacokinetic studies including:
- Characterisation of absorption, metabolism and pharmacokinetics
- Design and interpretation of in vitro drug-drug interaction studies
- Conduct of TK study design, analyses and reporting
- Author or review relevant regulatory documents
Bioanalytical Services
We are able to provide expertise in review of bioanalytical methods in preclinical and clinical studies. We have authorship experience with multiple 2.7.1 documents and authored >3 submissions in the first half of 2021.
Scientific Writing
We have a team of highly skilled scientists and writers who are able to support report writing and authorship of regulatory documents.