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Randomization of generic products in two groups to establish if in vivo failure was incidental (one batch) or constant (any batch): identification of non-therapeutically equivalent generics is independent of the batches of each product studied in vitro and/or in vivo.

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*This product (AZ pharma batch 009040) was commercialized later as Recipe (batch 009040) and therefore tested in the animal model, failing that test too (†). However, AZ pharma batches 303030 (in vitro) and 0110059 (in vivo) did not fail; (please see Discussion).

*本产品(AZ pharma批次009040)后续以代号Recipe(批次009040)完成商业化推广,随后开展动物模型测试,同样未通过该测试 (†)。然而,AZ pharma批次303030(体外实验)与0110059(体内实验)均顺利通过测试;详见讨论章节。
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2010-05-20
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