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.