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Registerincreased solubility = different PK profile? [Dissolution / BCS / IVIVC]
posted by Helmut 
– Vienna, Austria, 2017-06-08 19:18 (2503 d 18:16 ago) – Posting: # 17463
Views: 14,104
Dear Dan,
do I get you right: BCS Class 2?
Cmax is a lously PK metric. It is pretty insensitive to changes in the rate of absorption (papers by the two Lászlós two decades ago). Let’s say you will get the same AUC. Then the true rate of absorption (ka) can increase a lot until you will fall out of the BE-limits for Cmax.
No idea.
Yes.
No.
do I get you right: BCS Class 2?
❝ IMHO in case dissolution is the time determining step you are confronted with the following dilemma: either you can reach the same Cmax but you would have a lower AUC and vice versa you can reach the same AUC but Cmax will be increased.
Cmax is a lously PK metric. It is pretty insensitive to changes in the rate of absorption (papers by the two Lászlós two decades ago). Let’s say you will get the same AUC. Then the true rate of absorption (ka) can increase a lot until you will fall out of the BE-limits for Cmax.
❝ The shorter t1/2 the more pronounced is this effect, right?
No idea.
❝ And if you can not demonstrate bioequivalence you are forced to conduct phase III studies for the registration of your new product and this makes the new product unattractive from a commercial point of view.
Yes.
❝ Do you have any experience in this field?
No.
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
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Complete thread:
- increased solubility = different PK profile? Dr_Dan 2017-06-08 16:57 [Dissolution / BCS / IVIVC]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- increased solubility = different PK profile? nobody 2017-06-08 17:16
- increased solubility = different PK profile?Helmut 2017-06-08 17:18
- increased solubility = different PK profile? nobody 2017-06-08 17:22
- ka vs. Cmax Helmut 2017-06-09 14:35
- ka vs. Cmax nobody 2017-06-09 16:27
- ka vs. Cmax mittyri 2017-06-10 14:59
- ka vs. Cmax Helmut 2017-06-09 14:35
- increased solubility = different PK profile? nobody 2017-06-08 17:22
- increased solubility = different PK profile? ElMaestro 2017-06-08 17:24
- increased solubility = different PK profile? Dr_Dan 2017-06-08 17:36
- increased solubility = different PK profile? nobody 2017-06-08 17:43
- increased solubility = different PK profile? Ohlbe 2017-06-08 18:23
- increased solubility = different PK profile? nobody 2017-06-08 18:58
- increased solubility = different PK profile? ElMaestro 2017-06-08 18:45
- increased solubility = different PK profile? nobody 2017-06-08 18:57
- increased solubility = different PK profile? nobody 2017-06-09 09:38
- increased solubility = different PK profile? nobody 2017-06-08 18:57
- increased solubility = different PK profile? Dr_Dan 2017-06-08 17:36
- increased solubility = different PK profile? Kiran 2017-06-24 11:02
Ing. Helmut Schütz