Pharmacokinetic (PK/PD) Analysis
R&D Research & Development
Quantitative bioanalytical support for PK/PD programmes across all stages of drug development and therapeutic modalities.
Pharmacokinetics (PK) and pharmacodynamics (PD) are fundamental to every drug development programme. The ability to accurately quantify drug concentrations in biological matrices, characterise metabolic profiles, and model pharmacodynamic responses is not only a scientific priority but also a regulatory requirement underpinning critical development decisions.
AMSbiopharma provides comprehensive PK/PD bioanalytical services to pharmaceutical and biotechnology sponsors across multiple stages of drug development. We support a wide range of therapeutic modalities—including small molecules, therapeutic peptides, biologics, oligonucleotides, and gene therapy vectors—using analytical strategies tailored to the specific characteristics of each drug candidate.
All bioanalytical methods are developed and validated in accordance with ICH M10 guidelines, ensuring scientifically robust, high-quality data suitable for regulatory submissions.
Pharmacokinetic (PK/PD) Analysis
Accurate quantification of drug concentrations in biological matrices is the foundation of every pharmacokinetic programme. Our PK bioanalytical services support pharmacokinetic and preclinical toxicokinetic studies, providing the quantitative data required to characterise drug exposure throughout the development process.
We develop and validate bioanalytical methods for a wide range of biological matrices, including plasma, serum, whole blood, urine, cerebrospinal fluid (CSF), tissue homogenates, and dried blood spots (DBS). Full method development and validation are performed in accordance with ICH M10, covering specificity, selectivity, sensitivity, linearity, accuracy, precision, matrix effects, stability, and dilution integrity.
PK/PD data are delivered in formats compatible with leading pharmacokinetic and pharmacometric modelling software, enabling seamless integration into the sponsor’s development workflows. All studies are conducted under controlled documentation systems aligned with applicable regulatory requirements.
Key analytical capabilities
- Full ICH M10-compliant bioanalytical method development and validation for regulated studies
- Bioanalysis of plasma, serum, urine, CSF, tissue homogenates, and alternative biological matrices
- PK/PD data support for dose selection, exposure assessment, and regulatory submissions
- Applicable to small molecules, therapeutic peptides, biologics, oligonucleotides, and gene therapy vectors
DMPK – Drug Metabolism and Pharmacokinetic Analysis
Drug Metabolism and Pharmacokinetics (DMPK) studies provide a mechanistic understanding of how a compound is absorbed, distributed, metabolised, and excreted (ADME). This information is essential for predicting in vivo behaviour, optimising compound properties, and assessing the potential for drug–drug interactions (DDIs).
AMSbiopharma provides comprehensive DMPK bioanalytical support using both preclinical species and human-derived matrices. Our services include metabolic stability studies in hepatic matrices, metabolite profiling and identification by high-resolution mass spectrometry (HRMS), plasma protein binding, and blood-to-plasma partitioning. Metabolite identification studies are performed to standards suitable for regulatory submissions.
Our team delivers early-stage ADME screening to support lead selection and optimisation, as well as comprehensive, regulatory-grade metabolite profiling studies to support clinical development programmes.
Key analytical capabilities
- Metabolic stability screening in liver microsomes, hepatocytes, and S9 fractions
- Metabolite profiling and structural identification by high-resolution mass spectrometry (HRMS)
- Plasma protein binding and blood-to-plasma ratio determination
- Support for reactive metabolite risk assessment and drug–drug interaction (DDI) studies
