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The History of Clotting Factor Concentrates Pharmacokinetics

Past President of Italian Association of Haemophilia Centres (AICE), Via dello Statuto n.1, I-50129 Firenze, Italy
Academic Editor: Emmanuel Andrès
J. Clin. Med. 2017, 6(3), 35; https://doi.org/10.3390/jcm6030035
Received: 29 January 2017 / Revised: 3 February 2017 / Accepted: 7 March 2017 / Published: 20 March 2017
(This article belongs to the Special Issue Outstanding Advances in Hemophilia Therapies)
Clotting factor concentrates (CFCs) underwent tremendous modifications during the last forty years. Plasma-derived concentrates made the replacement therapy feasible not only in the hospital but also at patients’ home by on-demand or prophylactic regimen. Virucidal methods, implemented soon after hepatitis and AIDS outbreak, and purification by Mabs made the plasma-derived concentrates safer and purer. CFCs were considered equivalent to the other drugs and general rules and methods of pharmacokinetics (PK) were applied to their study. After the first attempts by graphical methods and calculation of In Vivo Recovery, compartment and non-compartment methods were applied also to the study of PK of CFCs. The bioequivalence of the new concentrates produced by means of recombinant DNA biotechnology was evaluated in head-to-head PK studies. Since the beginning, the large inter-patient variability of dose/response of replacement therapy was realized. PK allowed tailoring haemophilia therapy and PK driven prophylaxis resulted more cost effective. Unfortunately, the need of several blood samples and logistic difficulties made the PK studies very demanding. Recently, population PK (PopPK) has been applied to the prediction of CFCs dosing by Bayesian methodology. By PopPK also sparse data may allow evaluating the appropriateness of replacement therapy. View Full-Text
Keywords: clotting factor concentrates; pharmacokinetics; compartment methods; Non-Compartment Analysis; Bayesian compromise; PopPK; prophylaxis; In Vivo Recovery; Clearance; Half-life; Volume of distribution clotting factor concentrates; pharmacokinetics; compartment methods; Non-Compartment Analysis; Bayesian compromise; PopPK; prophylaxis; In Vivo Recovery; Clearance; Half-life; Volume of distribution
MDPI and ACS Style

Morfini, M. The History of Clotting Factor Concentrates Pharmacokinetics. J. Clin. Med. 2017, 6, 35.

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