Propofol is anaesthetic agent and induces deep sleep when administered as intravenous injection to patients. Therefore, recruiting the healthy volunteers and dosing Propofol in healthy volunteers was critical considering its pharmacodynamic properties.
Initially we faced issues in recruitment of healthy volunteers, however in due course of time as we have gained more knowledge and experience on the drug, Propofol; we were able to generate more confidence among the volunteers. Based on our internal discussions with our expert team member, we were able to determine the safest approach and amount (dose calculation) of the drug to be administered to reduce the risk to the subjects. The approach was communicated with the EMEA agency and was accepted.
The clinical part of the biostudy is required to be conducted in ICU setup. Conducting the study in hospital with GCP compliant by itself is a challenge.
The hospital staff did not have proper understanding on GCP guidelines and Good Documentation Practices. Therefore, we designed and provided a proper set of check points and checklists which ensured that the study executed at hospital complied with all necessary regulatory requirements. Based on our experience, we were able to pin point the hotspots where there were chances of confusion between CRO and hospital. Our checkpoints and checklists also ensured the proper duty delegation to hospital and CRO thus avoiding eleventh hour rush and confusion.
Cmax is the critical parameter showing high intra subject variability due to faster absorption in systemic circulation following intravenous administration. In such scenario, selecting accurate sampling time points is a challenge following bolus dose.
Our experience with such molecules, review of literature and discussion with physician helped us in changing dosing procedure from bolus to infusion with accurate dead volume calculations with the help of specialised and advance tools. Similarly pharmacokinetic sampling time points were revised with changed dosing procedures allowing buffer time during initial frequency of samples.
DCGI approval for conducting bioequivalence study in healthy volunteers.
Our overall experience over biostudies with supportive literature data in healthy subjects and toxicity data helped us in presenting sufficient data along with application to the DCGI.
Coordination between hospital and CRO as well as training to hospital staff to have smooth execution of study.
Based on our experience, we are able to pin point the hotspots where there are chances of confusion between CRO and hospital. Our checkpoints and checklist ensure the proper duty delegation to hospital and CRO thus avoiding eleventh hour rush and confusion.
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