What inspired this Wish List Request?
Dissolution is an important pharmaceutical centric feature in JMP. Regulatory dissolution is a crucial tool in the development and marketing of pharmaceutical products. This process is used to test and determine the rate and extent of a drug's release from its formulation into the body. And it helps the generic pharmaceutical industry to avoid costly bioequivalence testing in humans and forms a basis for biowaivers.
Please describe the new or improved feature or solution you would like to see.
- Introduce following model dependent approaches to dissolution testing: Zero order, first order, Probit, quadratic, exponential and Gompretz models as they as they are equally important for modeling dissolution and pharmaceutical formulation development and characterization in addition to the exiting capabilities.
- Introduction of Wellek’s T^2 EQ test: this test for equivalence is is used in dissolution testing to determine if the difference between the means of two groups is within a specified equivalence margin. If the difference between the means is smaller than the equivalence margin, the test concludes that the means are equivalent. If the difference is larger than the equivalence margin, the test concludes that the means are not equivalent and is prescribed by regulators as an alternative to the MSD approach
- Fit and compare selected dissolution models – as it helps compare the release profile and serve a real world use case need in formulation development
What would the value be to you and/or other users if this new feature is provided?
It will help enhance the JMP's dissoultion centric capabilities and make it more rounded from a regulatory customer's stance. The results of these tests are used by regulatory agencies to approve or reject a drug product, and to establish specific requirements for its manufacturing and labeling. The dissolution profile of a drug can also be used to monitor its quality over time and detect any changes in its formulation that may affect its efficacy or safety. It will serve the needs of generic and regulated pharmaceutical customers in the US, EMEA, Japan, China, India, and Latin America.
Is this an external customer request? As JMP is scoped by the customers in generics and regualted segments of the industry having a fully rounded capabality in dissoultion testing will draw potential customers.
Is there a competitive software package that has this feature or solution that we should be aware of?
Pharmaceutical Dosage Forms | In Vitro Dissolution Chemistry (simulations-plus.com)
Phoenix IVIVC Toolkit | Certara
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2895453/
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?
Potential users in regulated pharma are interested in JMP's dissolution curve analysis; having a complete end-to-end dissolution method and regulatory dissolution will attract more customers to JMP. Also, this new feature will add to JMP's strong phara capabalities in DOE QbD and stability , making it a good choice for both current customers and new ones.
