Clinical Pharmacology - Pharmakinetic Ltd

Strategy Analysis and Review

Understanding Your Data

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 contributed to the development 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 drug candidate

Impact Assessment

Assessment of how emerging PK & PD data affects the further development of the drug candidate

Study Design

Expertise applied to the design of clinical studies such as; food interaction, renal & hepatic impairment, ADME. Includes advice on PK blood sampling schedules and dose selection

Evaluation of Novel Formulations

Design, analysis and interpretation of bioavailability and bioequivalence studies

Assessment of
Drug Drug Interactions

Clinical study design to evaluate
CYP and transporter interactions
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

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Unlock your drug’s potential with our pharmacokinetic expertise