Regulatory Verification by Health Canada of Content in Recombinant Human Insulin, Human Insulin Analog, and Porcine Insulin Drug Products in the Canadian Market Using Validated Pharmacopoeial Methods Over Nonvalidated Approaches.
Journal of diabetes science and technology（2023）
摘要
Because insulin drug products are used daily by over a million Canadians, it is important that researchers and journals present data using methods fit for purpose and that readers evaluate such reports critically.
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关键词
HPLC,bioanalytical,biotherapeutics,drug products,insulin,pharmacopoeia
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