{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,19]],"date-time":"2026-09-19T07:18:27Z","timestamp":1789802307942,"version":"4.0.1"},"reference-count":33,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2024,12,22]],"date-time":"2024-12-22T00:00:00Z","timestamp":1734825600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001665","name":"Agence Nationale de la Recherche","doi-asserted-by":"publisher","award":["ANR\u201022\u2010PESN\u20100017"],"award-info":[{"award-number":["ANR\u201022\u2010PESN\u20100017"]}],"id":[{"id":"10.13039\/501100001665","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Br J Clin Pharmacol"],"published-print":{"date-parts":[[2025,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>Mycophenolic acid (MPA), the active component of enteric\u2010coated mycophenolate sodium (EC\u2010MPS), exhibits highly variable pharmacokinetics. Only a few population pharmacokinetic (popPK) models and Bayesian estimators (MAP\u2010BE) exist for estimating MPA AUC and all in renal transplantation. This study aimed to develop a popPK model and MAP\u2010BE for MPA AUC estimation using a limited sampling strategy (LSS) in solid organ transplant (SOT), haematopoietic stem cell (HSC) recipients and patients with autoimmune diseases (AID) on EC\u2010MPS.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      Full and sparse MPA pharmacokinetic profiles were extracted from our ISBA system, split into development (75%) and validation (25%) sets. An additional extraction was performed after the modelling process for external validation. Pharmacokinetic parameters were estimated using Monolix\u00ae (SAEM algorithm). Several absorption models (first order, transit, gamma) were compared. AUC\n                      <jats:sub>predicted<\/jats:sub>\n                      by MAP\u2010BE and LSS was compared to the all\u2010sample MAP\u2010BE AUC\n                      <jats:sub>reference<\/jats:sub>\n                      using Simulx\u00ae.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>We included 153 PK profiles (863 concentration) from 129 patients (116 SOT and HSC, 13 AID), median [min\u2013max] age 45\u2009years [6\u201380]. A one\u2010compartment model with double\u2010gamma absorption and first\u2010order elimination best fitted the data. The final model included the EC\u2010MPS indication and inter\u2010occasion variability on gamma rate constants. Main PK parameters (mean\u2009\u00b1\u2009SD) were Cl\/F\u2009=\u20094.99\u2009\u00b1\u20092.22\u2009L\/h and Vd\/F\u2009=\u200912.60\u2009\u00b1\u20090.08\u2009L. The optimal LSS at 20\u2009min, 2\u00a0h and 4\u00a0h post\u2010dose showed good performance in both validation sets (rMPE \u22122.67% and \u22124.91%; RMSE 13.55% and 13.47%).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The double\u2010gamma absorption model provided an accurate fit. The MAP\u2010BE offers a tool for EC\u2010MPS dose individualization in SOT, HSC and AID patients.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/bcp.16374","type":"journal-article","created":{"date-parts":[[2024,12,22]],"date-time":"2024-12-22T22:24:09Z","timestamp":1734906249000},"page":"1396-1408","source":"Crossref","is-referenced-by-count":4,"title":["Killing several birds with one stone: A multi\u2010indication population pharmacokinetic model and Bayesian estimator for enteric\u2010coated mycophenolate sodium"],"prefix":"10.1111","volume":"91","author":[{"given":"Yeleen","family":"Fromage","sequence":"first","affiliation":[{"name":"Department of Pharmacology, Toxicology and Pharmacovigilance CHU de Limoges  Limoges France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hamza","family":"Sayadi","sequence":"additional","affiliation":[{"name":"Department of Pharmacology, Toxicology and Pharmacovigilance CHU de Limoges  Limoges France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin","family":"Koloskoff","sequence":"additional","affiliation":[{"name":"Pharmacology &amp; Transplantation, INSERM U1248 Universit\u00e9 de Limoges  Limoges France"},{"name":"ExactCure  Nice France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7698-0760","authenticated-orcid":false,"given":"Pierre","family":"Marquet","sequence":"additional","affiliation":[{"name":"Department of Pharmacology, Toxicology and Pharmacovigilance CHU de Limoges  Limoges France"},{"name":"Pharmacology &amp; Transplantation, INSERM U1248 Universit\u00e9 de Limoges  Limoges France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5840-8904","authenticated-orcid":false,"given":"Marc","family":"Labriffe","sequence":"additional","affiliation":[{"name":"Department of Pharmacology, Toxicology and Pharmacovigilance CHU de Limoges  Limoges France"},{"name":"Pharmacology &amp; Transplantation, INSERM U1248 Universit\u00e9 de Limoges  Limoges France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caroline","family":"Monchaud","sequence":"additional","affiliation":[{"name":"Department of Pharmacology, Toxicology and Pharmacovigilance CHU de Limoges  Limoges France"},{"name":"Pharmacology &amp; Transplantation, INSERM U1248 Universit\u00e9 de Limoges  Limoges France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1695-0695","authenticated-orcid":false,"given":"Jean\u2010Baptiste","family":"Woillard","sequence":"additional","affiliation":[{"name":"Department of Pharmacology, Toxicology and Pharmacovigilance CHU de Limoges  Limoges France"},{"name":"Pharmacology &amp; Transplantation, INSERM U1248 Universit\u00e9 de Limoges  Limoges France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,12,22]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/ajt.15672"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.2011.96"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1093\/ndt\/gfu184"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1097\/FTD.0000000000000871"},{"key":"e_1_2_11_6_1","unstructured":"European Medicines Agency.Summary of Product Characteristics: CellCept 250 mg hard capsules. 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