Pharmacokinetic study of Avastin: Cadila to submit revised protocol to CDSCO committee
New Delhi: The apex drug regulatory body, Central Drug Standard Control Organisation's (CDSCO) Subject Expert Committee (SEC) recently recommended drug firm, M/S Cadila to submit a revised protocol for conducting a comparative pharmacokinetic study of Bevacizumab.
The CDSCO committee deliberated that –
- The objective of the study can be achieved with 1mg/kg instead of 3mg/kg.
- The infusion of the drug in healthy volunteers should be done in a hospital facility setting to manage side effects which includes hypertensive crisis, oxygen desaturation, chest pain, diaphoresis etc.
Additionally, the drug is also known to cause other serious effects such as intestinal perforation and hence proper to follow up to ensure the care of the volunteer in case of an emergency has to be built in the protocol.
In view of the above, the CDSCO committee recommended the following modifications;
- The dose of Bevacizumab should be decreased to 1mg/kg.
- The site of the study should be a tertiary care hospital with in-house facilities of ICU and its team including critical specialist and Para-medical staff trained in ICU care.
- The number of volunteers to be studied at a one-time point should be proportional to the ICU beds, staff strength and other facilities and should be defined in the protocol.
- The follow up in case of side effect and proposed action to be taken should be clearly defined in the protocol.
Accordingly, the firm should submit the revised protocol and submit the details of the sites, facilities etc. for review by the CDSCO committee.