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RegisterAssay percentage, Healthy volunteer, PI [Regulatives / Guidelines]
Dear Madam/Sir,
I have foolowing few queries:
What happens when the assay percentage of Investigational product (between test and reference) is more than 5% in conducting a Bioequivalence study?
Why healthy volunteers are taken for BA/ BE study?
What is basic qualification required for Principal Investigator? Can a MBBS doctor be a Principal Investigator? Is this accepted by regulatory (India)?
Kind regards,
I have foolowing few queries:
What happens when the assay percentage of Investigational product (between test and reference) is more than 5% in conducting a Bioequivalence study?
Why healthy volunteers are taken for BA/ BE study?
What is basic qualification required for Principal Investigator? Can a MBBS doctor be a Principal Investigator? Is this accepted by regulatory (India)?
Kind regards,
Complete thread:
- Assay percentage, Healthy volunteer, PIraghavendra_s 2010-11-25 04:29
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Assay percentage, Healthy volunteer, PI manan 2010-11-25 10:43
- Assay percentage, healthy volunteers Helmut 2010-11-25 15:44
- Potency correction? It depends d_labes 2010-11-26 10:38
- THX! Helmut 2010-11-26 14:18
- Assay percentage, healthy volunteers Marcel 2011-06-24 15:19
- Healthy volunteers vs. patients Helmut 2011-06-24 15:40
- Healthy volunteers vs. patients Marcel 2011-06-24 16:03
- Healthy volunteers vs. patients Helmut 2011-06-24 15:40
- Potency correction? It depends d_labes 2010-11-26 10:38
Ing. Helmut Schütz