Supporting All Stages of Drug Development
Medpace Bioanalytical Laboratories works on studies from all stages of drug development including programs in the discovery and development stage. Drug discovery in the past was very much based on luck and happenstance. For example, the drug development of penicillin took a giant leap forward when Alexander Flemming’s petri dish containing bacteria called Staphylococcus had a mold contamination that inhibited bacteria growth near the mold. However, in classical pharmacology, which is the more modern method of drug discovery, libraries of chemical compounds are screened in cells or in living organisms to help identify compounds that might have the desired therapeutic effect. In most cases, bioanalysis is needed to help screen and optimize drug candidates. Medpace Bioanalytical Laboratories has the experience and expertise to expertly perform the bioanalytical aspects of the drug discovery and development process.
The final step in the discovery and development stage of drug development is lead optimization. The goal of lead optimization is to chemically modify the lead candidates to maintain beneficial characteristics and eliminate undesirable characteristics. The lead compounds would be optimized to have favorable PK properties. At Medpace Bioanalytical Laboratories PK lead optimization and drug candidate screening studies can be developed rapidly, within hours, which helps create an efficient workflow for your screening studies.
Discovery and Development Guidance Documents
- FDA Guidance Document – Bioanalytical Method Validation
- FDA Guidance Document – M10 Bioanalytical Method Validation
- FDA Guidance Document – Good Laboratory Practices Questions and Answers
- ICH Guidance Document – Safety Pharmacology Studies for Human Pharmaceuticals
- ICH Guidance Document – Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
- EMA Guidance Document – Guideline on Bioanalytical Method Validation