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2. US Food and Drug Administration (2020) Guidance for industry (draft) - pharmacokinetics in patients with impaired renal function — study design, data analysis, and impact on dosing and labeling. https://www.fda.gov/media/78573/download. Accessed 10 Dec 2022
3. ICH E11(R1) - Clinical investigation of medicinal products in the pediatric population (2018). https://database.ich.org/sites/default/files/E11_R1_Addendum.pdf. Accessed 10 Dec 2022
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