PK evaluations – implemented for drug approval

SocraTec R&D performs classical non-compartmental (NCA) pharmacokinetic analyses for pilot studies and pivotal trials used for approval in the EU and worldwide including the FDA and ANVISA. From first-in-man to bioequivalence trials – our experience covers all relevant settings over decades of practical experience:

  • Design development and sample size estimations
  • Trial protocol writing
  • Logistical support for multicentre PK studies in patients
  • Study performance in phase-I settings as well as later phases
  • Statistical Analysis Plan development
  • Evaluation and interpretation of study results

Evaluations are run by a team of experienced PK analysts, all of them with a university background. All evaluation steps are SOP-based and embedded in a comprehensive quality assurance system with internal quality control procedures for all potentially vulnerable steps, based on a systematic risk analysis. Scientifically critical steps affected by subjective components, e.g., the selection of data points for determining the terminal elimination rate are always done under the Scientific Director’s supervision.

PK – technical details

Our NCA evaluation is based on Phoenix WinNonlin® and established in a validated IT environment. Statistical analyses of PK parameters are either done in WinNonlin® or SAS® depending on the sponsor’s requirements.

The principles of US-FDA CFR 21 part 11 are applied for FDA approvals.

PK services – more than NCA analysis?

Are you confronted with more sophisticated and more challenging pharmacokinetic questions? Where population pharmacokinetics (PopPK) may be a meaningful approach? You do not know whether NONMEM® may help you to solve your problem? Or you need an expert to perform such evaluations? What to do when ADA interferes with the PK of your biological? Maybe you need to embed your PK evaluation in a comparability exercise for biosimilars? If such questions are of relevance for you, standard solutions are not sufficient.
In such cases – contact us. Our experts will help to identify and implement an adequate solution. And if necessary, our excellent network of external scientists will support us in solving your problem.

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