Statistics for PK/PD

Quantics has years of experience applying our world-leading expertise to PK/PD statistics. Our team uses cutting-edge statistical techniques to ensure the timely delivery of even the most complex projects.

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Whether you’re planning your next study or approaching license application, Quantics is here to help. Our detailed approach to quality management – and deep understanding of the latest guidance – means we can provide relevant support at every stage along the road to regulatory approval.

Non-Compartmental Analysis (NCA)

For all analyses, Quantics can provide all results required for regulatory submission, including:

  • Area under Curve (AUC)
  • Peak Concentration (Cmax)
  • Time of Peak Concentration (Tmax)
  • Volume of Distribution (Vd)
  • Clearance (CL)
  • Slope Estimation (Lambda-z)
  • Volume of Distribution at Steady State (VSS)

Quantics can also advise on statistical requirements for regulatory submission of PK/PD Studies during study design.

PK/PD Statistics: A typical concentration-time curve showing metrics such as Cmax, Tmax and AUC

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World-leading expertise and years of experience in PK/PD statistics

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Support throughout the journey to regulatory approval

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PK/PD statistics all year round

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Compartmental Analysis

Quantics can provide an analysis which treats the body as multiple compartments, and uses differential equations to model how the drug moves from absorption to excretion. This is crucial when combining with PD data to effectively model how the drug interacts with the body.

Population PK (PopPK)

Quantics is also at the forefront of research on Population PK (PopPK), a form of compartmental analysis which takes patient covariates – such as age, weight, and pre-exisiting conditions – into account when fitting a PK model. This can highlight where the behaviour of the drug varies with these factors, and can help inform dosing decisions, among other benefits. The more sophisticated analysis also means that PopPK can be used with sparser data than other PK/PD methodologies.

Find out more about Population PK
PopPK: Models of plasma concentration

What is PK/PD?

Pharmacokinetics (PK): The study of how a drug moves through the body, from absorption to excretion.

Pharmacodynamics (PD): The study of how a drug affects the body, including both therapeutic and side effects.

Together, PK & PD form the field of Pharmacology. Pharmacology aims to study drugs and how they interact with the body. This is vital for ensuring that our drugs perform the job we expect while minimising the occurrence of adverse side effects.

For the safety and efficacy of any drug to be understood, both its PK and PD need to be characterized. And, since the two are intrinsically linked, combined PK/PD studies are common.

Get in Touch!

Need PK/PD Statistics? Use the form below to book a 30 Minute discovery call with our Customer Experience Manager, Andy Rust (andy.rust@quantics.co.uk).

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