Bioequivalence and Bioavailability Forum • Randomization access

Randomization access [Regulatives / Guidelines]

posted by Ohlbe – France, 2015-08-17 20:14 (3970 d 00:56 ago) – Posting: # 15287
Views: 5,622

Dear Balaga,

❝ Is there is any restriction that the bioanalytical department should not be accessable to randomization schedule? If so, please let me know the source guidelines.

EMA BE guideline, § 4.1.7, last line:
Analysis of samples should be conducted without information on treatment.

—
Regards
Ohlbe

Complete thread:

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- Randomization accessOhlbe 2015-08-17 18:14