Bridging drug discovery, and clinical studies, the preclinical development stage is an iterative process that involves several critical steps, including chemical scale-up, formulation development, bioanalysis, DMPK, toxicology testing, and clinical trial supply preparation. Each of these steps is essential to ensure that a potential new drug candidate is safe, and effective before it is tested in humans. Through careful planning, and rigorous testing, our researchers can identify promising drug candidates that have the potential to improve the lives of patients around the world.
To evaluate any serious harmful potential of the drug, toxicology assays are conducted, while DMPK assays are carried out to support ADME properties assessment. These studies are performed by our experts in bioanalysis, checking accurate dosage levels, and measuring drug, and metabolites concentration levels in biological matrices.
In parallel, the chemical properties of the drug candidate, such as solubility or stability also influence its performances. An efficient chemical development route design as well as formulation development are also key to ensure the efficacy of the drug candidate.
To maintain the quality of your drug from lab to shelf, our analytical development & QC team has extensive experience in designing reliable, and robust analytical test methods. While moving from bench to bedside, our clinical trial supply experts can support the manufacturing of your medicinal products for use in phase I-IV clinical studies as well as compassionate use/expanded access programs.
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