ChemDiv chemistry of cures

This Phase, often referred to as Translational R&D is a critical step in preparing and then testing the drug candidate in patients. First the candidate must be shown to be safe and effective in animal test systems, the candidate is made in larger quantities (Process Chemistry and Scale-up), formulations suitable for human dosage are developed and the dossier is submitted to the Regulatory Agencies for approval to begin human testing. All stages of this process are heavily regulated and all data and documentation must meet exact standards mandated by the regulatory bodies. ChemDiv complies with all regulatory requirements in their registered laboratories to allow the smooth transition to human studies and to complete the process for the Investigational New Drug Application (IND).

First Human Doses are usually administered to healthy normal volunteers in a hospital setting to determine if the drug is bio-available and to confirm that it is safe to administer to patients. This Phase 1A and Phase1B study involves a small number of patients under carefully regulated conditions prior to early evaluation of the drug in the appropriate patient population (Phase 2A). During the Phase 2A studies we are looking for evidence that the drug is having the desired therapeutic effect (Proof of Principle) prior to testing in a larger number of patients to demonstrate Proof of Concept (POC).

See Also:

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Target to Lead
Lead to Candidate
POC to Market
Translational Research