1. EMA, Reflection paper on investigation of pharmacokinetics and pharmacodynamics in the obese population (EMA/CHMP/535116/2016). https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-investigation-pharmacokinetics-pharmacodynamics-obese-population_en.pdf. Access date: 17.07.2023
2. EMA, Draft guideline on quality and equivalence of topical products (CHMP/QWP/708282/2018). https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-quality-equivalence-topical-products_en.pdf Access date: 17.07.2023
3. EMA, Draft Lapatinib film-coated tablet 250 mg product-specific bioequivalence guidance (EMA/CHMP/257298/2018). https://www.ema.europa.eu/en/documents/scientific-guideline/lapatinib-film-coated-tablet-250-mg-product-specific-bioequivalence-guidance-first-version-2nd-draft_en.pdf Access date: 17.07.2023
4. ICH, Draft guideline ICH guideline M10 on bioanalytical method validation (EMA/CHMP/ICH/172948/2019).https://www.ema.europa.eu/en/documents/scientific-guideline/draft-ich-guideline-m10-bioanalytical-method-validation-step-2b_en.pdf Access date: 17.07.2023
5. ICH, Draft Guideline M13A on bioequivalence for immediate-release solid oral dosage forms (EMA/CHMP/ICH953493/2022). https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-m13a-bioequivalence-immediate-release-solid-oral-dosage-forms-step-2b_en.pdf Access date: 17.07.2023