Meeting this timeline requires close collaboration between the companies. AniClin works with the new chemical entity (NCE), performing dosing and collecting plasma samples which are delivered to Taylor within two hours, according to the companies.
Taylor processes the samples to develop non-good laboratory practice (GLP) bioanalytical protocols, data analysis and estimation of PK parameters. Data is then emailed to the sponsor.
The overall package covers formulation, dosing, PK sampling, bioanalysis of six time points.