Discovery & Development
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.
Screening Compounds
Initially, the discovery stage may have thousands of potential compounds as candidates for development but after early testing and screening, only a handful of candidates are chosen for further development. Once the potential drug candidates have been narrowed down, further data is gathered on the lead compounds to characterize their potential as viable drug candidates. This may include in vitro assays such as CYP450 as well as in vivo R&D DMPK studies. Determining the mechanism of action (MOA) may also be performed. Dosage, route of administration, toxicity, effectiveness compared to other drugs, and drug-drug interaction information may also be gathered at this stage as well. As the drug development process is iterative, many of these studies will be refined and expanded upon in later stages of drug development. Medpace is well equipped to assist with the bioanalytical components of these screening studies and has extensive experience performing drug discovery and development studies. Medpace Bioanalytical Laboratories would be an excellent choice for conducting discovery and development of bioanalytical studies.
Lead Optimization
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
