Choroby wewnętrzne
Kardiologia
Medycyna rodzinna
Biorównoważność leków generycznych – na podstawie leku Tikagrelor Sandoz
Dr n. med. Małgorzata Zaremba
18 listopada 2025

Ukończ ten artykuł i zdobądź 10 punktów rozwiązując krótki quiz.
Rozwiąż quizArtykuł napisany przez:Dr n. med. Małgorzata Zaremba
SPEAK_MED_040_06-2025_001
Piśmiennictwo
- 1Guidance for Industry. Statistical Approaches to Establishing Bioequivalence. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) January 2001 BP. (Internet) http://www.fda.gov/cder/guidance/index.htm
- 2Ulrich Jaehde U, Radziwill R, Charlotte Kloft Ch. Farmacja kliniczna. Red. wyd. pol. Anna Wiela-Hojeńska. MedPharm Polska 2014 Wrocław. ISBN: 9788378460176.
- 3Guideline on the Investigation of Bioequivalence. Committee for Medicinal Products for Human Use (CHMP). London 2010.
- 4Rozporządzenie 536/2014 w sprawie badań klinicznych produktów leczniczych stosowanych u ludzi oraz uchylenia dyrektywy 2001/20/WE. Dz.U.UE.L.2014.158.1 Wersja od: 5 grudnia 2022 r. System Informacji Prawnej LEX: https://sip.lex.pl/akty-prawne/dzienniki-UE/rozporzadzenie-536-2014-w-sprawie-badan-klinicznych-produktow-leczniczych-68430444System
- 5Consolidated text: Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) (Codified version) (Text with EEA relevance)Text with EEA relevance. Access: http://data.europa.eu/eli/dir/2004/9/2019-07-26
- 6van Giezen JJ, Nilsson L, Berntsson P i wsp. Ticagrelor binds to human P2Y(12) independently from ADP but antagonizes ADP-induced receptor signaling and platelet aggregation. J Thromb Haemost. 2009;7:1556–65. doi: 10.1111/j.1538-7836.2009.03527.x.
- 7Husted S, van Giezen JJ. Ticagrelor: the first reversibly binding oral P2Y12 receptor antagonist. Cardiovasc Ther. 2009; 27:259–74. doi: 10.1111/j.1755-5922.2009.00096.x
- 8Dorsam RT, Kunapuli SP: Central role of the P2Y12 receptor in platelet activation. J Clin Invest. 2004 ;113(3): 340-5. doi: 10.1172/JCI20986.
- 9Charakterystyka Produktu Leczniczego (ChPL) Tilobrastil, 60 mg, tabletki powlekane. 20.12.2024
- 10Charakterystyka Produktu Leczniczego (ChPL) Tilobrastil, 90 mg, tabletki powlekane. 20.12.2024
- 11Indraswari F, Dai X, Shu L i wsp. Antiplatelet Therapies After Ischemic Stroke. PRACTICAL NEUROLOGY. 2022: 34-38.
- 12Giorgi MA, Cohen Arazi H, Gonzalez CD, Di Girolamo G. Beyond efficacy: pharmacokinetic differences between clopidogrel, prasugrel and ticagrelor. Expert Opin Pharmacother. 2011; 12:1285–95. doi: 10.1517/14656566.2011.550573.
- 13Teng R, Oliver S, Hayes MA, Butler K. Absorption, distribution, metabolism, and excretion of ticagrelor in healthy subjects. Drug Metab Dispos. 2010; 38:1514–21. doi: 10.1124/dmd.110.032250
- 14Dobesh PP, Oestreich JH. Ticagrelor: pharmacokinetics, pharmacodynamics, clinical efficacy, and safety. Pharmacotherapy. 2014 Oct;34(10):1077-90. doi: 10.1002/phar.1477.
- 15Teng R. Ticagrelor: Pharmacokinetic, Pharmacodynamic and Pharmacogenetic Profile: An Update. Clin Pharmacokinet. 2015;54(11):1125-38. doi: 10.1007/s40262-015-0290-2.
- 16Angheloiu GO, Gugiu GB, Ruse C, Pandey R, Dasari RR, Whatling C: Ticagrelor Removal From Human Blood. JACC Basic Transl Sci. 2017 Apr 24;2(2):135-145. doi: 10.1016/j.jacbts.2017.01.007.
- 17Adamski, P., Buszko, K., Sikora, J. et al. Metabolism of ticagrelor in patients with acute coronary syndromes. Sci Rep 8, 11746 (2018). https://doi.org/10.1038/s41598-018-29619-9
- 18Tantry US, Bliden KP, Wei C, et al. First analysis of the relation between cyp2c19 genotype and pharmacodynamics in patients treated with ticagrelor versus clopidogrel: the onset/offset and respond genotype studies. Circ Cardiovasc Genet. 2010;3(6):556-566.
- 19Scientific discussion Ticagrelor Sandoz 60 mg and 90 mg, film‐coated tablets (ticagrelor). Public Assessment Report NL/H/4872/001‐002/DC. Date: 18 March 2021.
- 20Hashmi, N., Jawaid, M., & Shah, M. R. (2023). Bioequivalence assessment of two Ticagrelor formulations under fasting condition in healthy Pakistani subjects. Pakistan Journal of Medical Sciences, 39(6), 1647–1651. https://doi.org/10.12669/pjms.39.6.8203





