Tag: regulatory standards

16 Dec
Batch Variability and Bioequivalence: What Acceptable Limits Really Mean
Simon loxton

Batch Variability and Bioequivalence: What Acceptable Limits Really Mean

Batch variability in generic drugs can skew bioequivalence results, leading to false approvals or rejections. Learn how modern standards are shifting from single-batch tests to multi-batch analysis for more reliable generic drug approval.

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