Rana jaouni

2020-03-18 20:37

Posting: # 21285
Views: 1,989

 RLD batch number in fed and fast studies [Regulatives / Guidelines]

Dear All

Please suggest me whether we can do Fasting and Fed BE Studies of same Molecule with two different batches of RLD?

We have conducted fasting pivotal study with one batch of reference product but the used batch may become expired Before we can conduct the fed pivotal study due to COVID-19 situation.

Please advise will the studies be acceptable by the US FDA, European and Brazil authorities?

Thanks in advance.

Vienna, Austria,
2020-03-18 20:46

@ Rana jaouni
Posting: # 21286
Views: 795

 RLD batch number in fed and fast studies

Hi Rana,

of course, you could. See this recent thread.

Helmut Schütz

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