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Registersample size query [Regulatives / Guidelines]
hello all,
Can anybody share any FDA document, which shows (/documents) that the minimum sample size (approx.24+standby) for a pivotal study? Its a ba/be in healthy volunteers US Submission. Kindly attach the supportive documents if u have.
Thanx in advance,
kaushik
Can anybody share any FDA document, which shows (/documents) that the minimum sample size (approx.24+standby) for a pivotal study? Its a ba/be in healthy volunteers US Submission. Kindly attach the supportive documents if u have.
Thanx in advance,
kaushik
Complete thread:
- sample size querykaushik089 2012-08-15 18:17
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Consult the GL collection first! Helmut 2012-08-15 18:32
Ing. Helmut Schütz