Search Results - "Pottackal, Ginto"

Clinical pharmacology considerations for the approval of belimumab for the treatment of adult patients with active lupus nephritis: A regulatory perspective by Liu, Tao, Neuner, Rosemarie, Thompson, Aliza, Pottackal, Ginto, Petullo, David, Liu, Jiang, Nikolov, Nikolay, Sahajwalla, Chandrahas, Doddapaneni, Suresh, Chen, Jianmeng

“…On 16 December 2020, FDA approved Benlysta® (belimumab) for both the intravenous (IV) and subcutaneous (SC) administration routes for the treatment of adult…”
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On the Assessment of Average Biosimilarity Based on a Three-Arm Parallel Design by Pottackal, Ginto Jacob, Mathew, Thomas

“…Average biosimilarity is investigated under a three-arm parallel design: one arm corresponds to the test drug T, and the other two arms correspond to two…”
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Some Tests, Confidence Limits and Tolerance Limits for Assessing Biosimilarity by Pottackal, Ginto

“…Biosimilars or follow-on biologics are defined as biological medicinal products that are expected to be similar to a licensed biological product. The standard…”
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