Non-Compartmental Analysis of Pharmacokinetic Data: Considerations to Gain Efficiencies and Meet SEND Requirements

Pharmacokinetic (PK) data gathered in the early phases of drug discovery program can provide insights on a compound’s mechanism of action, identify specific attributes of interest and guide decision points to optimize downstream development. Selecting the most appropriate analysis technique is essential to computing PK parameters.

This article discusses how non-compartmental analysis (NCA) of pharmacokinetic data can help support regulatory filings, create predictive simulations and help researchers select lead molecules or formulations. We also explore the topic of data handling as differing approaches and anomalous results can cause delays through investigations and inconsistencies across a program. Finally, we’ll cover unique considerations when working with biologics and the challenges involved with submitting regulatory filings formatted to the Standard for Exchange of Nonclinical Data (SEND) specifications. Continue reading

Integrated Solutions: Combining Multiple Endpoints into a Single Study Delivers Greater Confidence

covance_knife“The whole is greater than the sum of its parts” is often quoted to inspire teamwork and synergy but it can also apply to drug development. Studies that assess endpoints in isolation have value and can achieve the desired outcome.  Yet, many times a more complicated picture emerges and assessing multiple endpoints in a combined study reveals a more holistic view.

Inspired by the 3Rs—reduction, refinement and replacement of animals used in safety testing—the possibility of integrating multiple endpoints into one study is shaping new best practices in early drug development. Integrated solutions can maximize the value of each study to provide a better understanding, reveal earlier decision points and produce greater confidence in clinical outcomes.

While the concept seems straightforward, it’s not only a combination of otherwise standalone studies. Integrated solutions require a unique blend of fit-for-purpose experimental strategies tailored to each unique drug development program and the relevant endpoints. Continue reading