Pharmacokinetic (PK) and Pharmacodynamic (PD) studies play a vital role in clinical trials, providing crucial insights into how a drug interacts with the human body. PK/PD studies are conducted to provide valuable data to support the development and regulatory approval of new drugs.
PK analyses focus on how the body processes a drug, including absorption, distribution, metabolism, and excretion, guiding optimal dosing regimens and ensuring safety. Abiogenesis expertise is significant in advancing drug development by providing expertise, resources and infrastructure in conducting high-quality PK/PD studies efficiently and in compliance with regulatory standards.
Abiogenesis provides full-service solutions for PK/PD studies to support development programs of new dosage forms and generic drugs.
We provide the following PK/PD Studies Services .
- Biometrics
- Study Execution
- Data Management
- Protocol Development
- Feasibility Assessment
- Central Laboratory Support
- Ethics Committee Submissions
- Bioanalytical Laboratory Support
- Clinical Study Report (CSR) Writing
- Liaising With Regulatory Authorities for Approvals
