Which book? [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2012-03-17 15:46 (4806 d 21:51 ago) – Posting: # 8293
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Servus Franz!

❝ I cross-checked the L. Endrenyi/L Tothfalusi chapter in Kanfer/Shargel’s book “Generic Drug Product Development”


Cough. That’s not a book, but a series of books
#201 (International Regulatory Requirements for Bioequivalence, informa 2010) referred in FDA’s guidance contains no chapter by the two Laszlos. Before buying another one of the series in the blind which one do you have?

BTW, it’s funny that the guidance states in the introduction:

For detailed information on this approach, please refer to the published book chapter […]

which actually gives much less information than the guidance itself.

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