What inspired this Wish List Request?
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?
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/
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.
