PK/PD
GLP studies in rodents and pigs.
At MD Biosciences we support IND-enabling studies and assist in several ways. Our dedicated team of scientists helps plan the studies with appropriate endpoints, biomarkers and methodologies that align with regulatory requirements. We perform preclinical studies in rodents and pigs, and can include components like pharmacology, toxicology, and pharmacokinetics. At MD Biosciences we generate data and results for FDA submission and have quality control and quality assurance processes in place to ensure that each step of the study meets the requirements.