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RegisterAssay percentage, Healthy volunteer, PI [Regulatives / Guidelines]
Dear Mr. Raghvendra
I would like to share my ideas on your other two querries here.
usually, the BA BE studies are carried out in normal healthy volunteers. however, some olass of drugs like anti cancer needs to be carreid out in patients. Enrolling healthy volunteers minimizes any trial releated problems and is well mentioned in almost all the guidlines. the physiological conditions of diseased person is obivoulsy dieffernet from that of a normal healthy volunteer.
Secondly, as per the ICH, GCP guidline, section 4.1 an Investigator MUST BE QUALIFIED BY EDUCATION, TRAINING AND EXPERIENCE TO ASSUME RESPONSIBILITY FOR PROPER CONDUCT OF TRAIL. i guess a MBBS cna become a PI or a Co-I provided he has a good experience and is trained.
Edit: Please don't shout, and see this post. [Helmut]
I would like to share my ideas on your other two querries here.
usually, the BA BE studies are carried out in normal healthy volunteers. however, some olass of drugs like anti cancer needs to be carreid out in patients. Enrolling healthy volunteers minimizes any trial releated problems and is well mentioned in almost all the guidlines. the physiological conditions of diseased person is obivoulsy dieffernet from that of a normal healthy volunteer.
Secondly, as per the ICH, GCP guidline, section 4.1 an Investigator MUST BE QUALIFIED BY EDUCATION, TRAINING AND EXPERIENCE TO ASSUME RESPONSIBILITY FOR PROPER CONDUCT OF TRAIL. i guess a MBBS cna become a PI or a Co-I provided he has a good experience and is trained.
Edit: Please don't shout, and see this post. [Helmut]
Complete thread:
- Assay percentage, Healthy volunteer, PI raghavendra_s 2010-11-25 04:29
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Assay percentage, Healthy volunteer, PImanan 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