Detailed expertise to improve the success rate of product development.
Understand your products' Pharmocokinetics
Our Biometrics team will carefully analyse bioavailability and characterise a drug’s ADME properties (absorption, distribution, metabolism and excretion) through the process of studying the movement of drugs through the body. Pharmacokinetics (PK) helps our team to understand how the body reacts to drugs, allowing our clients, the developers, and our expert clinicians to design the most effective and efficient clinical studies expertly designed with detailed recommendations around dosage, drug interaction in the body as well as addressing patient diversity.
Accelagen’s Biometrics team can design and execute a broad series of studies focused on the clinical side of drug development, ultimately aimed at improving your drug development’s success rate.
Accelagen’s Biometrics team can design and execute a broad series of reporting focused on PK analysis
Analyses of studies
Our certified NCA analysts utilise the power of Certara Phoenix WinNonlin to build study workflows that integrate with the SAS programming of the study CDISC datasets to deliver PK datasets as part of the End of Study data package, ready for Regulatory submission.
Workflows are constructed according to the PK Analysis Plan, including handling of BLOQ results and missing data, data exclusion based on terminal phase criteria, and Non-compartmental analyses of single and multi-dose studies.
Accelagen’s Biometrics team can design and execute a broad series of studies focused on the clinical side of drug development, ultimately aimed at improving your drug development’s success rate.
Interim PK Reports for Review Committees
Utilising the reporting module within WinNonlin, interim PK reports, complete with listings, summary tables, and figures, can be produced with a rapid turnaround for review committees to support cohort reviews throughout a study, for example during early-phase ascending dose studies.
Dose proportionality
Taking our NCA to the next level, our WinNonlin workflows can be expanded to assess dose proportionality of key parameters (AUC or Cmax), using power models. Our team conducts analyses in SAS.
Bioequivalence
WinNonlin workflows can be expanded to integrate a variety of model-based analyses, including bioequivalence, fed-fast and drug-drug interaction studies.