Log in
Register|
raghavendra_s ★ 2011-01-19 08:06 (5641 d 09:33 ago) Posting: # 6445 Views: 3,277 |
|
|
Dear Madam/Sir, I have few queries on BE studies. When we can consider a Bioequivalence study considered as Phase I study? Please locate me to the required BE guidelines to follow in Syria Whether there are separate protocols needed for bioavailibility and bioequvalance studies for aerosols, and other formulations or general protocol for all formulations is sufficient Is there any compensation guidelines for the volunteers who are participating in clinical trial or BA-BE studies. How all are paid at every corner of the world, with respect to guideline of respective country or USFDA or EU, etc. Are they paid uniformly or differently? how? Thanks in advance, |
|
Helmut ★★★   Vienna, Austria, 2011-01-19 13:37 (5641 d 04:02 ago) @ raghavendra_s Posting: # 6449 Views: 2,613 |
|
|
Dear Raghavendra! ❝ When we can consider a Bioequivalence study considered as Phase I study? All BE studies are in Phase I, though I've seen protocols stating "Phase I/IV": Phase I for the generic and Phase IV for the innovator. ❝ Please locate me to the required BE guidelines to follow in Syria No idea; I guess Syria is follwing WHO's guideline. Consider asking them. ❝ Is there any compensation guidelines for the volunteers who are ❝ participating in clinical trial or BA-BE studies. No one I know of. Generally the compensation is judged by the EC. For example in Germany you may run into trouble if the compensation is too high. ❝ How all are paid at every corner of the world [...] Are they paid uniformly ❝ or differently? how? Differently, depending on the country's general income. Even within Europe there are large differences in the per capita PPP-GDP (Norway $52,964, Bulgaria $12,067). USA $47,701, Canada $39,037, India $3,176... Within a country the compensation depends on the number of administrations and blood samples drawn, the duration of hospitalization, eventual additional PD measurements, etc. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Ing. Helmut Schütz