By Dr Hayley Kain, Pharmacokinetic Scientist at Agilex Biolabs
Rapid Data. Smarter Decisions. No Delays.
In early-phase clinical development, time is everything – especially during Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) studies. While high-quality bioanalysis is essential, it’s the rapid pharmacokinetic (PK) data analysis that enables informed, real-time decisions on dose escalation and trial progression.
Agilex Biolabs now offers in-house PK data analysis to complement our industry-leading bioanalytical services – ensuring your program moves seamlessly from sample to insight.
Why Pharmacokinetic Data Analysis Matters in SAD/MAD Studies
PK data analysis, specifically non-compartmental analysis (NCA), answers essential questions such as:
- How quickly is the drug absorbed and eliminated? (i.e. Tmax, t1/2)
- What is the exposure at different dose levels? (i.e. Cmax, AUC)
- Is drug accumulation between doses within a safe and expected range?
- Is it safe to proceed to the next dose escalation?
In SAD and MAD designs, timely PK insights are crucial. Delays in interpretation can lead to:
- Paused dosing cohorts
- Avoidable protocol amendments
- Site inefficiencies and increased trial costs
- Regulatory and ethical concerns regarding participant safety
The Agilex Advantage: Integrated PK Data Analysis Services
By offering in-house PK data analysis, we eliminate the traditional handover gap between bioanalysis and interpretation. As soon as the QC-checked bioanalysis data is available, our PK team can begin analysis—often within minutes. Our standard turnaround time for interim analysis and reporting is 48–72 hours.
This integrated approach offers:
- Fast turnaround—ideal for time-sensitive Phase 1 studies
- Direct collaboration between our bioanalytical and PK experts
- A single, accountable partner from sample receipt to final reporting
- Streamlined data flow and reduced risk of communication errors
- Flexibility to support adaptive designs and real-time decisions
What to Expect from PK Data Analysis at Agilex Biolabs
Our dedicated pharmacokinetic scientists provide tailored support for early-phase studies, including:
- A comprehensive PK data analysis plan to ensure scientific consistency, quality, and regulatory compliance
- Use of Phoenix WinNonlin, the industry standard for non-compartmental analysis (NCA), i.e., reporting parameters such as Cmax, AUC, and half-life
- Allocation of blinded subject IDs to maintain the integrity of treatment allocation
- Rapid interim PK analysis and reporting (i.e., PK Memo) following each SAD or MAD cohort, prepared for review by the Safety Review Committee (SRC) or Dose Escalation Committee (DEC)
- A QA-audited, GCP-compliant final PK analysis report covering all cohorts with unblinded subject IDs and expert interpretation
- Delivery of PC and PP domains, ready for seamless integration into the client’s SDTM dataset
Make Faster, Safer Decisions with Agilex
In early-phase trials, the ability to quickly analyze PK samples and interpret the data can be the difference between momentum and costly delay. With Agilex Biolabs as your partner, you gain the speed, accuracy, and confidence needed to progress efficiently through each dosing cohort.
Ready to Streamline your Phase 1 Study?
Connect with our Business Development team to learn how we can integrate real-time PK data analysis into your clinical program at BD@AgilexBiolabs.com.
Need TK Data Analysis for Your Toxicology Program?
Agilex Biolabs also offers in-house toxicokinetic (TK) data analysis for both GLP and non-GLP preclinical toxicology studies. Whether your studies are conducted at Agilex or with an external partner, and whether or not Agilex performs the bioanalysis, our TK analysis services offer the same speed, quality, and seamless integration as our PK services.
Reach out to our BD team today at BD@AgilexBiolabs.com.
