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Method for predicting in-vivo PK/PD change after Selpatinib combined medication through PBPK-RO model

A serpa, model technology, applied in the establishment of serpatinib PBPK-RO model, the application of serpatinib tablets in the field of PK and PD effects in the human body, can solve problems such as liver effects, and achieve accurate The effect of high degree and avoiding adverse effects

Pending Publication Date: 2022-01-28
药融云数字科技(成都)有限公司
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Problems solved by technology

However, the applicant's research found that serpatinib has a serious impact on the liver, and only focusing on PK changes cannot truthfully or fully reflect the safety and effectiveness of the drug in the body, especially the safety of the drug for people aged 12-18 , and patients with severe liver damage or liver damage are greatly affected. It is particularly important to accurately grasp the changes in the drug body, better control drug doses, and reduce adverse drug reactions

Method used

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  • Method for predicting in-vivo PK/PD change after Selpatinib combined medication through PBPK-RO model
  • Method for predicting in-vivo PK/PD change after Selpatinib combined medication through PBPK-RO model
  • Method for predicting in-vivo PK/PD change after Selpatinib combined medication through PBPK-RO model

Examples

Experimental program
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Embodiment 1

[0074] In this example, the Serpatinib PBPK-RO model was constructed with the help of Berkeley Madonna (Version 10.2.8, Berkeley Madonna, Inc., Albany, CA, USA). Serpatinib basic property parameters are shown in Table 1 (data from FDA review documents,

[0075] https: / / www.accessdata.fda.gov / drugsatfda_docs / nda / 2020 / 213246Orig1s000MultidisciplineR.pdf). The in vivo PK curve data of Serpatinib are shown in Table 2 (data from FDA review documents). The parameters of human physiological attributes used in the PBPK model are shown in Table 3 (the simulated population is American male Caucasian, the average age is 30 years old, the average weight is 80.4Kg, the BMI index is 25.2, and the data comes from the built-in software).

[0076] Table 1

[0077]

[0078]

[0079] Table 2

[0080] time (h) Concentration (ng / mL) 0.25 17.89 0.5 133.96 0.8 419.69 1.0 1267.92 2.0 1482.26 3.0 1410.88 4.0 1285.93 8.0 964.68 10.0 750....

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Abstract

The invention relates to an establishment method and application of a Selpatinib PBPK-RO model. A scientific model established in the invention is used for evaluating the influence of a CYP3A4 inhibitor and a PPIs drug on the PK and PD of a Selpatinib tablet in a human body and predicting and evaluating the change of Selpatinib in the human body.

Description

technical field [0001] The invention belongs to the technical field of computational pharmacokinetics and computational pharmacology, and in particular relates to a method for establishing a Serpatinib PBPK-RO model and its application, in particular to the use of the model to evaluate the effect of CYP3A4 inhibitors and PPIs drugs on Application of erpatinib tablets in PK and PD effects in humans. Background technique [0002] Genomic alterations of the RET kinase include fusions and point mutations, resulting in hyperactive RET signaling and uncontrolled cell growth. RET fusions and mutations occur with varying frequencies in a variety of tumor types. According to clinical statistics, about 1%-2% of patients with non-small cell lung cancer have RET gene fusion. On May 8, 2020, the first targeted drug targeting RET fusion mutations, Selpercatinib, was approved by the FDA, marking that the target of RET has officially become a therapeutic target with "targeted drugs availa...

Claims

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Application Information

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IPC IPC(8): G16H70/40G16H50/30G16B5/00G16C10/00G16H10/20
CPCG16H70/40G16H50/30G16B5/00G16C10/00G16H10/20
Inventor 王中健朱凌峰
Owner 药融云数字科技(成都)有限公司
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