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    Pharmacokinetic study of Avastin: Cadila to submit revised protocol to CDSCO committee

    Farhat NasimWritten by Farhat Nasim Published On 2019-10-01T16:09:49+05:30  |  Updated On 1 Oct 2019 4:09 PM IST
    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.




    Bevacizumab, sold under the trade name Avastin, is a medication used to treat a number of types of cancers and a specific eye disease.


    The firm presented their proposal for conducting a comparative pharmacokinetic study(the study of the time course of drug absorption, distribution, metabolism, and excretion) of Bevacizumab in healthy volunteers for the export purpose along with published reports of PK/Phase I studies conducted on healthy volunteers.


    Also Read: Police protection for Drug Regulators, Inspectors, recommends CDSCO committee


    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.


    Also Read: CDSCO committee recommends exemption of chemical contraceptive FDC from Schedule H; Details

    AvastinbevacizumabcancerCDSCOcdsco committepharmapharma newspharma news indiapharmacokinetic studySEC CommitteeSubject expert committee

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    Farhat Nasim
    Farhat Nasim

      Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751 To know about our editorial team click here

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