What inspired this Wish List Request?
Using noncompartmental analysis, (NCA), one can derive the pharmacokinetic (PK) parameters of a drug by looking at the measured drug concentrations over the course of time. Because of the nature of this approach, the assumption of a particular compartmental model is not necessary. NCA is frequently utilised to determine the degree of exposure that occurs after the administration of a drug, such as the AUC, as well as other pharmacokinetic parameters, such as the clearance and the terminal half-life. NCA curve fits are favoured by the regulators and are an essential part of the bioavailability / bioequivalence (BA/BE) studies. The present Fit Curve > Pharmacokinetic models only support oral and two compartment IV Bolus. Hence, the introduction of a NCA PK curve fit for oral and IV infusion and bolus would be highly beneficial from a regulatory standpoint.
Please describe the new or improved feature or solution you would like to see.
Generic Drug industry is a mainstay for pharmaceutical businesses and is valued at ($ 255 Bn ( 2021 est.). Equivalence trials are typically conducted using a crossover design, but a parallel design can also be used. Bioequivalence trials compare two drugs. The FDA believes that if two drugs have similar absorption properties, they will have similar effects and safety profiles. An equivalence trial evaluates a generic drug's equivalence to an existing drug. This is done by comparing a confidence interval about the difference between two drugs' pharmacokinetic measurements with a U.S. federal confidence limit. Bioequivalence is declared if the confidence interval is within the limit. Test interval hypotheses to assess bioequivalence. Several pharmacokinetic measures determine a drug's bioavailability. AUC is the most common measure (AUC).Maximum concentration (Cmax) is another measure of drug availability and its associated PK measures. Also, a statistical summary of the NCA PK fits helps to understand the drug disposition profile across subjects of the trial.
What would the value be to you and/or other users if this new feature is provided?
Pharmaceutical companies and CROs currently use SAS and other nonlinear curve fit tools to do the NCA and having this feature inbuilt into JMP completes the development spectrum of the drug product with JMP. Since a pharmacokinetic curve fit already exits in JMP and extending its capability will entice more customers and would complete the entirety of this capability.
Is this an external customer request?
Customers evaluating JMP especially for curve fit capabilities like Dissolution, Pharmacokinetics will find this feature worthy. Also complementing to this feature is Dissolution and - if this being a part of JMP can entice a buying decision for pharmaceutical customers.
Is there a competitive software package that has this feature or solution that we should be aware of?
https://www.certara.com/software/phoenix-winnonlin/
https://www.stata.com/features/epidemiology/
https://www.mathworks.com/help/simbio/
https://lixoft.com/products/pkanalix/
and several other open source solutions
Will this impact a renewal, expansion, or adoption at a customer, and does this put an account at risk if we do not address this?
Having a NCA and its associated bioequivalence and PK capabilities will round out the pharmacokinetic capabilities. Not to mention that, when viewed through the lens of biowaivers, it complements well with dissolution capabilities, and it would cater to the entire user base working in the drug development and generic drug development areas and compliments JMP C. It also entices users who use PK case tools to consider JMP.
