Optimizing Drug Development with PK/PD Expertise
A comprehensive understanding of how drugs are absorbed, distributed, metabolized, and excreted is essential for making informed decisions throughout drug development and clinical trial design.
The Role of Pharmacokinetics (PK) & Pharmacodynamics (PD)
PK/PD studies are crucial for drug approval, as nearly 25% of the information on a drug label is derived from PK/PD data. Careful planning and smart study design can significantly accelerate the development process, ensuring that safety and efficacy goals are achieved efficiently.
Our PK/PD Services at CRK Clinical Research Key
We provide expert guidance to optimize study designs, focusing on:
- Dose selection
- Population selection
- Sampling schedules
- Drug-drug interactions
Our Specialized Services Include:
- PK/PD and PBPK modeling
- A dedicated team of clinical pharmacologists and biostatisticians
- Utilization of SimBiology software for advanced modeling
Types of Studies We Support:
- PK studies in special populations (hepatic and renal impairment, elderly)
- Drug-drug interaction studies
- Regulatory expertise with EMA & FDA guidelines
Leverage CRK’s expertise to streamline your drug development process and achieve faster regulatory approvals.
