Clinical Pharmacology

Clinical Pharmacology

Strategy, Analysis and Review

Information generated by clinical pharmacology studies can contribute up to 50% of the final product label, so a coherent strategy towards this aspect of drug development is essential.

PharmaKinetic have experience of small molecules and biologics, covering several therapeutic areas. Through our expert knowledge of both clinical pharmacology and the regulatory environment we are able to offer you an objective input into your development programmes. Thereby helping you on your way to achieving global regulatory success.

Addressing your Clinical Pharmacology Challenges

PharmaKinetic can apply our knowledge to address these challenges for you:

Programme Design

Using clinical pharmacology data to aid
progression and registration
of the compound

Impact Assessment

Assessing the impact of clinical trial results on the further development of the compound

Study Design

Clinical pharmacology and patient PK,
including specialist designs
such as renal and hepatic impairment, ADME, FIH

Evaluation of
Novel Formulations

Design, analysis and interpretation of bioavailability and bioequivalence studies

Clinical Assessment of Drug Drug Interactions

Study Design

CYP and transporter interaction

Advice on co-medication
in patient studies

Integration of Preclinical PK/PD data

Contributing to candidate selection plus dose choice for first-in-human studies to maximise the data return

PK data analysis

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Contact PharmaKinetic