You can obtain the pharmacometrics report template using the following command:
quarto use template PeterBloomingdale/pmx-report-templateThis command will will create a file named pmx-report-template.qmd. Executing this document will create a PDF of the pharmacometrics report. For more information on customizing this document visit Quarto
This report template has been generated based on the guidelines provided in the 2022 Population PK guidance from the FDA. The guidance is aimed to assist sponsors and applicants of new drug applications (NDAs), biologics license applications (BLAs), abbreviated new drug applications (ANDAs), and investigational new drugs (IND) applications in the application of population pharmacokinetic (PK) analysis, which is crucial for guiding drug development and informing recommendations on therapeutic individualization. Adherence to these guidelines ensures a well-structured and comprehensive presentation of the population PK analyses, facilitating a clear understanding for regulatory review and potentially alleviating the need for postmarketing requirements or commitments.