Biopharmaceutical history [NCA / SHAM]
Dear D. Labes!
The phrase 'the flatter is better' was used in the mid-1980s of the last century. For some drugs AEs were found to be correlated with fast absorption rates / high Cmax-values (the classical example is nifedipine). Some clinicians went so far to demand modified release formulations ('flatter' profile) for all drugs intended for long term use. Questionable developments following this concept were modified release formulations of drugs with long half-lives (example: amitriptyline). In the meantime it became evident that a 'one-size-fits-all-concept' is not suitable. There are drugs where a fast initial 'ramp' is necessary for the effect. Therefore the concept was abandoned and filed in the history section of biopharmaceutics.
The phrase 'the flatter is better' was used in the mid-1980s of the last century. For some drugs AEs were found to be correlated with fast absorption rates / high Cmax-values (the classical example is nifedipine). Some clinicians went so far to demand modified release formulations ('flatter' profile) for all drugs intended for long term use. Questionable developments following this concept were modified release formulations of drugs with long half-lives (example: amitriptyline). In the meantime it became evident that a 'one-size-fits-all-concept' is not suitable. There are drugs where a fast initial 'ramp' is necessary for the effect. Therefore the concept was abandoned and filed in the history section of biopharmaceutics.
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Helmut Schütz
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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:
- Statistics in multiple dose study ratnakar1811 2009-12-01 11:09 [NCA / SHAM]
- Statistics in multiple dose study Helmut 2009-12-02 00:20
- Statistics in multiple dose study ratnakar1811 2009-12-03 07:36
- Statistics in multiple dose study Helmut 2009-12-03 14:53
- Statistics in multiple dose study ratnakar1811 2009-12-04 08:21
- Statistics in multiple dose study Helmut 2009-12-03 14:53
- Metrics for multiple profiles d_labes 2009-12-03 08:58
- Metrics for multiple profiles Helmut 2009-12-03 15:50
- Metrics for multiple profiles d_labes 2009-12-03 16:02
- Metrics for multiple profiles Helmut 2009-12-03 16:11
- PTF is another story d_labes 2009-12-03 16:17
- PTF is another story Helmut 2009-12-03 16:42
- the flatter is better? d_labes 2009-12-04 08:46
- Biopharmaceutical historyHelmut 2009-12-04 12:35
- the flatter is better? d_labes 2009-12-04 08:46
- PTF is another story Helmut 2009-12-03 16:42
- Metrics for multiple profiles d_labes 2009-12-03 16:02
- Metrics for multiple profiles Helmut 2009-12-03 15:50
- Statistics in multiple dose study ratnakar1811 2009-12-03 07:36
- Statistics in multiple dose study Helmut 2009-12-02 00:20