PKxpert helps you with
- Study design, dose setting, calculation and reporting of nonclinical and clinical PK studies, small molecules and biologics.
- Calculation of Pharmacokinetic or Toxicokinetic studies, with GLP Compliance Statement.
- Simulations and modelling of study designs: dose settings and exposure predictions.
- Pharmacokinetic and Pharmacodynamic (PKPD) modelling and simulation.
- Study design, monitoring, evaluation and reporting of preclinical and clinical ADME (Absorption Distribution, Metabolism, Distribution) studies.
- Development of integrated NonClincal and Clinical Development Plans to provide all necessasy documentation for IMPD (or IND) and NDA applications.
- Screening strategies to optimize your lead compounds with repect to their PK and DM properties.
- Preclinical and clinical PK and ADME regulatory documentation in all phases of the development, including filing a new drug application to authorities in US, Europa and Japan.
- Assistance with preparations for Scientific Advice Meetings at regulatory agencies
- Quality assurance (QA) activities in GLP-environment including audits and SOP documentation.
Examples of Assignments
- Perform pharmacokinetic/toxicokinetic analysis in preclinical safety studies for a new chemical entity (NCE) or new biological entity (NBE) projects, including input to study design.
- Build simulation models and simulate dosing regimens for preclinical toxicity studies and predict exposure in humans.
- Perform pharmacokinetic analysis in clinical studies for NCE or NBE projects, including input to study design.
- Monitoring of ADME studies at CROs.
- Design in vitro studies for drug-drug interactions.
- Evaluate pharmacokinetic data, build a simulation model and simulate other dosing intervals and regimens for next study as well as estimate exposure parameters in order to maximize the exposure.
- Review and update the preclinical development plan (PDP) in the areas: toxicology, safety pharmacology, bioanalysis, pharmacokinetics and pharmacodynamics for NBE or NCE.
- Write PK written summary in regulatory documents.
- Human Eqvivalent Dose (HED) and Maximum Anticipated Biological Effect Level (MABEL) calculations for dose setting in first human dose studies.
- PK representative in scientific advice meetings with MPA.
- Due Diligence, both sides - in and outlicencing.
- Input to study design of toxicology and PK studies.
- Predict human exposure from preclinical data.
- Build simulation models and simulate oral dosing regimens in humans
- Input to study design of toxicology studies, and toxicokinetic calculations and compiling of TK reports.
- Input to the study design of GLP toxicity studies.
- PK simulations to evaluate repeat dosing.
- Study design of Phase 1 and Phase 2 studies, and PK calculations in Phase 1 trial.
- Pharmacokinetic modelling of ongoing study, PK input to regulatory document, PK literature review, and literature review of the field of oral absorption of proteins.
- Coaching in house pharmacokineticist.
- QA activities: GLP compliance implementation and QA activities including audits.
- SOP documentation
