Comparative pharmacokinetics [General Statistics]
Dear ElMaestro!
A funny quote from Australia's TGA:
Part 2 - Study Type
Are you sure this is a bioavailability and/or bioequivalence
study (and not a pharmacokinetic study)?
A pharmacokinetic study concerns the properties of the drug whereas a bioavailability study concerns the properties of specific formulations or of different routes of administration. A food study is considered to be a bioavailability study. You are encouraged to contact the TGA to discuss studies if this is not clear for a given submission.
❝ to me, comparative pharmacokinetics is bioequivalence in practice (although it could mean a lot of other things).
A funny quote from Australia's TGA:
Part 2 - Study Type
Are you sure this is a bioavailability and/or bioequivalence
YES NO study (and not a pharmacokinetic study)?
A pharmacokinetic study concerns the properties of the drug whereas a bioavailability study concerns the properties of specific formulations or of different routes of administration. A food study is considered to be a bioavailability study. You are encouraged to contact the TGA to discuss studies if this is not clear for a given submission.
—
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
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
Complete thread:
- Comparative pharmacokinetics santosh.awale 2009-01-06 05:53
- Comparative pharmacokinetics santosh.awale 2009-01-09 06:01
- Comparative pharmacokinetics JPL 2009-01-09 09:28
- Comparative pharmacokinetics Helmut 2009-01-09 12:40
- Comparative pharmacokinetics ElMaestro 2009-01-09 15:38
- Comparative pharmacokineticsHelmut 2009-01-11 12:59
- Comparative pharmacokinetics ElMaestro 2009-01-13 14:14
- Comparative pharmacokinetics Helmut 2009-01-13 21:28
- Comparative pharmacokinetics santosh.awale 2009-01-15 10:24
- Comparative pharmacokinetics ElMaestro 2009-01-15 16:15
- Comparative pharmacokinetics santosh.awale 2009-01-15 10:24
- Comparative pharmacokinetics Helmut 2009-01-13 21:28
- Comparative pharmacokinetics ElMaestro 2009-01-13 14:14
- Comparative pharmacokineticsHelmut 2009-01-11 12:59
- Comparative pharmacokinetics santosh.awale 2009-01-09 06:01
