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Pharmacokinetics & Pharmacodynamics

The wide-ranging expertise and experience of our team across different stages of the clinical trial process means we’re able to quickly assess the pharmacokinetics of your drug, and characterize its absorption, distribution, metabolism and excretion by the human body.

Our highly-trained pharmacokineticists and pharmacometricians have significant experience in pharmacokinetic, bioavailability, and bioequivalence studies. Whether working with healthy subjects or in-patients, we’re always aligned with the requirements of the EMA, US FDA, or other relevant regulatory authorities.

Our team is fully proficient in non-compartmental (NCA) and model-based PK, PD, IVIVC and ER analyses using industry-leading software (Phoenix WinNonlin®).

We can plan, design, monitor, execute, analyse, and interpret your individual clinical or nonclinical PK studies. We can provide consultancy, pointed assignments for single studies, or contribute to programs of work.

How can we help you?

Contact our expert team to discover how Astrum can bring value to your clinical development projects.

 

Other services

  • Hospital-based Phase I unit

    The Hospital-based Phase I unit in Porto, Portugal can quickly and safely establish your product’s safety, dose range, or bioequivalence/bioavailability

  • Clinical Development & Scientific Advice

    Ranging from first in human to post-marketing, Astrum’s clinical development expertise spans the entire development cycle, offering support every step of the way

  • Quality Management

    Our Quality Management System represents an unwavering commitment to excellence within the pharmaceutical, 
biotechnology, and clinical research sectors