Interventional Agent Development Services
Examples of Services by Category
Lead Identification and Development
- Design lead optimization schemes (LOS) and generate chemical analogues
- Synthesize, resynthesize, or acquire compounds/interventional agents or chemical analogues for in vitro and in vivo studies
- Analyze structure activity relationships (SAR)
- Custom synthesize radio labeled compounds for in vitro and in vivo studies
- Optimize lead series to improve specific physiochemical or pharmacological properties
- Synthesize prodrug derivative(s).
Chemistry and Manufacturing
- Develop analytical methods to characterize interventional agents
- Develop and manufacture cGMP-qualified materials for preclinical and Phase I/II clinical use
- Conduct formulation studies
- Support cGMP-compliant stability program
In Vitro and In Vivo Preclinical Safety, Toxicology, and Biokinetics
- Develop analytical methods to characterize interventional agents
- Perform preclinical microbiological, safety, biokinetics and toxicity studies, such as in vitro microbiological assays
- Perform in vitro and In vivo pre-clinical safety, toxicology, and biokinetics studies, including
- maximum tolerated dose and no observed adverse effect levels (NOAEL)
- acute and sub chronic toxicity
- PK, Bioavailability, ADME
- Genotoxicity, carcinogenicity, reproductive toxicity testing
- Biotransformation assays conducted in vitro
- Cytotoxicity, immunotoxicity
- Behavioral pharmacology Cell permeability
Preclinical Development, Planning, and Evaluation
- Develop preclinical and/or product development plans
Content last reviewed on April 20, 2016