Publications by authors named "Jamila Joseph"
Introduction: The present study for biosimilar trastuzumab was a multicentric, randomized, two-arm parallel-group, comparative phase III study in patients with metastatic breast cancer.
Materials And Methods: Stage I of the study was conducted among 42 participants with equal distribution in the study and reference arm. After a loading dose of 8 mg/kg trastuzumab was administered intravenously on day 1 of the first cycle; serum samples were obtained at 0, 1.
Objective: To establish clinical biosimilarity of BevaciRel™ bevacizumab biosimilar (study bevacizumab) with the reference innovator bevacizumab in terms of pharmacokinetics, efficacy, and safety in metastatic colorectal cancer (mCRC).
Materials And Methods: A total of 119 patients with mCRC were enrolled across 20 centers and randomized to receive study and reference bevacizumab in this Phase III clinical study. Of these, 116 patients were administered bevacizumab 5 mg/kg intravenously every 2 weeks with folinic acid, fluorouracil, and irinotecan regimen.
India is getting to be known as a hot destination for executing clinical trials. It is witnessing the frenzied entry of pharma sponsor companies and contract research organizations and the movement of Indian non-healthcare groups into clinical research. In this mad melee, what are the determinants of success? How real is the promise of clinical research in India and what will make or break a new entrant in this business? This article attempts to describe these challenges and focuses on the resilient success criteria that the contract clinical research industry in India has tested every newcomer against.
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