Pharmacokinetics, Pharmacodynamics, and Toxicokinetics
Nonclinical to Clinical Pharmacology Services
Altasciences’ pharmacology team is equipped to support your drug development program for the entirety of its life cycle. We leverage our extensive experience and modern techniques to ensure seamless transitions at every step.
Support For Both Small and Large Molecules
Toxicokinetic (TK) Analysis
- Species and Study Designs: Toxicokinetic Principal Investigators (TK PIs) are adept at handling studies across various species and many study designs.
- Matrices: Experts specialize in analyzing data from diverse matrices, including tissues.
- Flexible Reporting: TK team provides detailed, stand-alone nonclinical reports for all our toxicokinetic analyses.
Pharmacokinetic (PK) Analysis
- Nonclinical and Clinical Studies: Services extend across phases of development, ensuring thorough analysis and support.
- Matrices: The PK team analyzes data from various matrices, adapting to the specific needs of your study.
- Flexible Reporting: Choose from stand-alone reporting or a report as part of a clinical study package.
Scientific Poster—Design and Validation of a Bioanalytical Method to Support a Clinical Pharmacokinetic Study Involving the Use of Multiple Lots of the Biological Therapeutic Drug.
Pharmacodynamic (PD) Analysis
- Expert Scientists: Pharmacokineticists are deeply involved in study design, data analysis, and reporting.
- Biomarker Data Analysis: Experts in biomarker data analysis (e.g., correlations with anti-drug antibody (ADA) levels) and our pharmacodynamics team handle various subjective measures, including visual analogue scales (VAS).
- PK/PD Correlations: The PD team specializes in identifying and interpreting correlations between pharmacokinetics and pharmacodynamics. Watch our webinar—Inside the Pharmacodynamic Toolbox.
Watch our webinar—Inside the Pharmacodynamic Toolbox
Scientific Journal: TOXICOKINETICS, PHARMACOKINETICS, AND PHARMACODYNAMICS take a closer look at the collection and use of PK/PD data in early-phase drug development.
Expertise and Compliance in Pharmacology
Our pharmacology team provides the following GCP and GLP-compliant services in support of your drug development programs:
- data management, programming, and CDISC SDTM and SEND dataset creation;
- design and interpretation of nonclinical and clinical studies;
- noncompartmental PK and TK analysis (NCA), for nonclinical and clinical studies using WinNonlin® (Phoenix);
- analysis plans;
- PK/PD correlative and inferential statistical modeling;
- interpretation of PK and PD outcomes;
- dose escalation decisions and review (rapid turnaround in PK analysis and interpretation);
- production of stand-alone PK/PD or input into the clinical study report; and
- comprehensive, submission-ready packages for regulatory authorities.