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RegisterLinear Pharmacokinetics of Levamlodipine [PK / PD]
Dear Maurico,
Here is some more background regarding linear PK you may find useful:
Linear kinetics: All transport processes follow a first order kinetic
Transport processes: absorption, distribution and/or elimination
First order kinetic: The concentration is changed at a rate proportional to the concentration
Non-linear kinetic: One or more transport process(es) follow other than first order kinetic, for example:
Zero order kinetic: The concentration is changed at a constant rate
Michaelis-Menten kinetic: The change of concentration over time is a function of the drug concentration (capacity limited processes)
On assumption of linear kinetics
PK parameters AUC and Cmax increase proportional with dose
PK parameters tmax , t1/2, CLs, Vss, MRT and F are independent of dose
Dose-proportionality studies allows assessing dose-related changes in exposure but not necessarily time related changes (e.g. auto induction of metabolizing enzymes, inhibitor formation, etc).
Regarding acceptance criteria you may find the following paper of interest:
Smith BP, Vandenhende FR, DeSante KA, Farid NA, Welsch PA, Callaghan JT and Forgue ST (2000). Confidence interval criteria for assessment of dose proportionality. Pharmaceutical Research, 17(10):1278-1283.
hope this helps & best regards
martin
Here is some more background regarding linear PK you may find useful:
Linear kinetics: All transport processes follow a first order kinetic
Transport processes: absorption, distribution and/or elimination
First order kinetic: The concentration is changed at a rate proportional to the concentration
Non-linear kinetic: One or more transport process(es) follow other than first order kinetic, for example:
Zero order kinetic: The concentration is changed at a constant rate
Michaelis-Menten kinetic: The change of concentration over time is a function of the drug concentration (capacity limited processes)
On assumption of linear kinetics
PK parameters AUC and Cmax increase proportional with dose
PK parameters tmax , t1/2, CLs, Vss, MRT and F are independent of dose
Dose-proportionality studies allows assessing dose-related changes in exposure but not necessarily time related changes (e.g. auto induction of metabolizing enzymes, inhibitor formation, etc).
Regarding acceptance criteria you may find the following paper of interest:
Smith BP, Vandenhende FR, DeSante KA, Farid NA, Welsch PA, Callaghan JT and Forgue ST (2000). Confidence interval criteria for assessment of dose proportionality. Pharmaceutical Research, 17(10):1278-1283.
hope this helps & best regards
martin
Complete thread:
- Linear Pharmacokinetics of Levamlodipine Mauricio Sampaio 2015-10-07 00:24
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Linear Pharmacokinetics of Levamlodipine Mauricio Sampaio 2016-06-03 22:33
- Quantification of S-amlodipine Mauricio Sampaio 2016-06-06 16:19
- Quantification of S-amlodipine Helmut 2016-06-06 20:23
- Quantification of S-amlodipine nobody 2016-06-07 08:29
- Quantification of S-amlodipine Mauricio Sampaio 2016-06-07 18:35
- Quantification of S-amlodipine Helmut 2016-06-08 01:32
- Quantification of S-amlodipine Mauricio Sampaio 2016-06-09 21:48
- Quantification of S-amlodipine Helmut 2016-06-08 01:32
- Quantification of S-amlodipine Mauricio Sampaio 2016-06-07 18:35
- Quantification of S-amlodipine nobody 2016-06-07 08:29
- Quantification of S-amlodipine Helmut 2016-06-06 20:23
- Quantification of S-amlodipine Mauricio Sampaio 2016-06-06 16:19
- Linear Pharmacokinetics of Levamlodipine martin 2016-06-09 15:22
- Linear Pharmacokinetics of Levamlodipine Mauricio Sampaio 2016-06-09 22:03
- Linear Pharmacokinetics of Levamlodipinemartin 2016-06-12 21:48
- Linear Pharmacokinetics of Levamlodipine Mauricio Sampaio 2016-06-09 22:03
- Linear Pharmacokinetics of Levamlodipine Mauricio Sampaio 2016-06-03 22:33
Ing. Helmut Schütz