Clinical pharmacology programs designed and implemented by us often incorporate additional endpoints, including the effect of food, the effect of age or gender, and pharmacodynamic or biomarker assessments. It is also common to complement a first-in-human to proof-of-concept program with a small patient cohort under a single protocol and regulatory submission.
Learn more about our Phase 1 clinical trials capabilities here
By manufacturing in real time in response to emerging clinical data, we can adjust drug dose and formulation between each group without slowing timelines.
We have designed and conducted numerous interaction studies, looking at the effects of single drugs and cocktails of drugs on enzymes as well as on other substances.
We have a wealth of experience in performing absolute bioavailability assessments using a variety of approaches, and can conduct bioequivalence studies no matter what the stage of development.
We regularly perform microdose studies, particularly at the stage of candidate selection, to compare drug analogues and identify a lead molecule with the preferred human PK properties to take forward to full clinical development.