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Posted On: 02/18/2018 4:26:31 PM
Post# of 72447
sox040713 Sunday, 02/18/18 04:23:57 PM
Re: PlentyParanoid post# 217318
Post #217975 of 217975
People who claim there's a dose-response relationship from 100 mg to 200 mg at least have some data to back it up, whereas people who claim efficacy maxes out at 200 mg have nothing to back it up. If IPIX thought 200 mg is the max, why didn't they include it as one of the arms in Phase 2b?
Here's where the PK/PD modeling comes in.
"Pharmacokinetic/pharmacodynamics (PK/PD) modeling, an integral component of the drug development process, is a mathematical technique for predicting the effect and efficacy of drug dosing over time."
https://www.mathworks.com/discovery/pharmacokinetic.html
PK/PD modeling predicted the dosage for B-ABSSSI Phase 2b correctly.
"Data from simulated patients demonstrated high average predicted percent probabilities of Sponsor-defined clinical success across the brilacidin dosing regimens evaluated. Application of the multivariable models for safety allowed for the brilacidin dosing regimens that best balanced the need for high efficacy and good safety to be identified."
https://static1.squarespace.com/static/571535...tions-.pdf
IMO the 300 mg and 400 mg dosages were the result of PK/PD modeling.
Re: PlentyParanoid post# 217318
Post #217975 of 217975
People who claim there's a dose-response relationship from 100 mg to 200 mg at least have some data to back it up, whereas people who claim efficacy maxes out at 200 mg have nothing to back it up. If IPIX thought 200 mg is the max, why didn't they include it as one of the arms in Phase 2b?
Here's where the PK/PD modeling comes in.
"Pharmacokinetic/pharmacodynamics (PK/PD) modeling, an integral component of the drug development process, is a mathematical technique for predicting the effect and efficacy of drug dosing over time."
https://www.mathworks.com/discovery/pharmacokinetic.html
PK/PD modeling predicted the dosage for B-ABSSSI Phase 2b correctly.
"Data from simulated patients demonstrated high average predicted percent probabilities of Sponsor-defined clinical success across the brilacidin dosing regimens evaluated. Application of the multivariable models for safety allowed for the brilacidin dosing regimens that best balanced the need for high efficacy and good safety to be identified."
https://static1.squarespace.com/static/571535...tions-.pdf
IMO the 300 mg and 400 mg dosages were the result of PK/PD modeling.
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