{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,2]],"date-time":"2026-07-02T14:30:08Z","timestamp":1783002608091,"version":"3.54.5"},"reference-count":73,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2025,1,14]],"date-time":"2025-01-14T00:00:00Z","timestamp":1736812800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Journal of Clinical Pharma"],"published-print":{"date-parts":[[2025,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Clinical pharmacology studies are critical for determining the efficacy and safety of drugs. Due to the resource\u2010intensive nature of these studies, most have been conducted in high\u2010income countries, leading to a significant gap in clinical pharmacology data for patients in low\u2010 and middle\u2010income countries. This paper provides an overview of the minimal requirements for performing a clinical pharmacology investigator\u2010initiated trial (IIT), including pharmacokinetic sampling. We identify common challenges in resource\u2010limited settings and propose strategies to overcome them. This guideline covers regulatory approval, participant recruitment, drug storage, sample collection and handling, transport, bioanalytical analysis, and data management tailored to the constraints of resource\u2010limited settings. Strategies are proposed to minimize resource demands, including simplified study designs, the use of technologies like whole blood microsampling, and opportunities for collaboration. The goal is to provide practical guidance for those seeking to perform a clinical pharmacology IIT in resource\u2010limited settings to improve safe and effective drug treatment for patients worldwide. Beyond the scope of this guideline is a detailed step\u2010by\u2010step guide on how to perform clinical pharmacology studies.<\/jats:p>","DOI":"10.1002\/jcph.6184","type":"journal-article","created":{"date-parts":[[2025,1,15]],"date-time":"2025-01-15T06:13:56Z","timestamp":1736921636000},"page":"675-687","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Investigator\u2010Initiated Clinical Pharmacokinetic Studies in Resource\u2010Limited Settings: Minimal Requirements and Practical Guidance"],"prefix":"10.1002","volume":"65","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0570-8177","authenticated-orcid":false,"given":"Aniek","family":"Uittenboogaard","sequence":"first","affiliation":[{"name":"Emma Children's Hospital Amsterdam UMC Vrije Universiteit Amsterdam  Amsterdam The Netherlands"},{"name":"Princess M\u00e1xima Center for Pediatric Oncology  Utrecht The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan","family":"Mageto","sequence":"additional","affiliation":[{"name":"Emma Children's Hospital Amsterdam UMC Vrije Universiteit Amsterdam  Amsterdam The Netherlands"},{"name":"Academic Model Providing Access to Healthcare (AMPATH)  Eldoret Kenya"},{"name":"Pharmacology School of Health Sciences Kisii University  Kisii Kenya"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sherif Kamal Eldin","family":"Mohamed","sequence":"additional","affiliation":[{"name":"Egypt Healthcare Authority Medication Management and Pharmacy Affairs  Cairo Egypt"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bertrand","family":"Pourroy","sequence":"additional","affiliation":[{"name":"Oncopharma Unit Pharmacy Department University Teaching Hospital of La Timone Assistance Publique Hopitaux de Marseille Universitaires de Provence  Marseille France"},{"name":"Groupe Franco\u2010Africain d'Oncologie P\u00e9diatrique (GFAOP) Institut Gustave Roussy  Villejuif France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Benjamin","family":"Mwesige","sequence":"additional","affiliation":[{"name":"Uganda Cancer Institute  Kampala Uganda"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Agness Chisomo","family":"Chitedze","sequence":"additional","affiliation":[{"name":"Baylor College of Medicine Children's Foundation  Lilongwe Malawi"},{"name":"Texas Children's Global Hematology\u2010Oncology\u2010Pediatric\u2010Excellence (HOPE) Program  Lilongwe Malawi"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gertjan","family":"Kaspers","sequence":"additional","affiliation":[{"name":"Emma Children's Hospital Amsterdam UMC Vrije Universiteit Amsterdam  Amsterdam The Netherlands"},{"name":"Princess M\u00e1xima Center for Pediatric Oncology  Utrecht The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Festus","family":"Njuguna","sequence":"additional","affiliation":[{"name":"Egypt Healthcare Authority Medication Management and Pharmacy Affairs  Cairo Egypt"},{"name":"Department of Child Health and Paediatrics Moi University  Eldoret Kenya"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,1,14]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/B978-0-12-802101-9.00020-X"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/B978-0-12-819869-8.00012-4"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.2217\/fon-2020-1262"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.2274"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41591-022-01738-x"},{"key":"e_1_2_8_7_1","first-page":"1","volume-title":"Medical Genetics Summaries","author":"Pratt VM","year":"2012"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1186\/2050-6511-14-49"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.15193"},{"key":"e_1_2_8_10_1","volume-title":"Guideline for good clinical practice E6(R2)","author":"International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). ICH E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) [Internet]","year":"2016"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-020-04620-8"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1093\/jac\/dkr596"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/pbc.31160"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1093\/jac\/dky071"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.01605-15"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12879-015-0862-7"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1136\/archdischild-2020-321426"},{"key":"e_1_2_8_18_1","unstructured":"World Health Organization.WHO registry criteria. Geneva: World Health Organization;\u00a02009. Accessed January 10 2025.https:\/\/www.who.int\/clinical\u2010trials\u2010registry\u2010platform\/network\/registry\u2010criteria"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00520-023-07913-1"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41598-024-59031-5"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.1002\/jgh3.12248"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjpo-2018-000298"},{"key":"e_1_2_8_23_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40262-021-01031-z"},{"key":"e_1_2_8_24_1","doi-asserted-by":"publisher","DOI":"10.1002\/jpen.1451"},{"key":"e_1_2_8_25_1","doi-asserted-by":"publisher","DOI":"10.2165\/00003088-198900171-00006"},{"key":"e_1_2_8_26_1","doi-asserted-by":"publisher","DOI":"10.1186\/1743-7075-6-50"},{"key":"e_1_2_8_27_1","doi-asserted-by":"publisher","DOI":"10.1111\/dewb.12090"},{"key":"e_1_2_8_28_1","doi-asserted-by":"publisher","DOI":"10.4103\/picr.PICR_172_17"},{"key":"e_1_2_8_29_1","doi-asserted-by":"publisher","DOI":"10.1080\/23294515.2018.1472148"},{"key":"e_1_2_8_30_1","first-page":"1","article-title":"How participatory is parental consent in low literacy rural settings in low income countries? Lessons learned from a community based study of infants in South India","volume":"12","author":"Rajaraman D","year":"2011","journal-title":"BMC Med Eth"},{"key":"e_1_2_8_31_1","unstructured":"Access to Medicine Foundation.Access to Medicine Index2022. Amsterdam; 2022 [cited 2025 Jan 10]. Available from:https:\/\/accesstomedicinefoundation.org\/resource\/2022\u2010access\u2010to\u2010medicine\u2010index"},{"key":"e_1_2_8_32_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-3156.2008.02106.x"},{"key":"e_1_2_8_33_1","doi-asserted-by":"publisher","DOI":"10.1177\/27550834221141767"},{"key":"e_1_2_8_34_1","unstructured":"World Health Organization.WHO Global Surveillance and Monitoring System for substandard and falsified medical products: World Health Organization;2017. Accessed January 10 2025. Available from:https:\/\/apps.who.int\/iris\/bitstream\/handle\/10665\/326708\/9789241513425\u2010eng.pdf."},{"key":"e_1_2_8_35_1","unstructured":"European Pharmacopoeia (Ph. Eu.).11th Edition.Council of Europe;2023. Accessed January 10 2025. Available from:https:\/\/www.edqm.eu\/en\/european\u2010pharmacopoeia\u2010ph.\u2010eur.\u201011th\u2010edition."},{"key":"e_1_2_8_36_1","doi-asserted-by":"publisher","DOI":"10.1007\/978-1-62703-050-2_16"},{"key":"e_1_2_8_37_1","doi-asserted-by":"crossref","unstructured":"OwenJ Fiedler\u2010KellyJ.Population model concepts and terminology.Introduction to Population Pharmacokinetic \/Pharmacodynamic Analysis with Nonlinear Mixed Effects Models. John Wiley & sons;\u00a02014. p.9\u201327.","DOI":"10.1002\/9781118784860.ch2"},{"key":"e_1_2_8_38_1","doi-asserted-by":"publisher","DOI":"10.1016\/B978-012369417-1\/50048-1"},{"key":"e_1_2_8_39_1","doi-asserted-by":"publisher","DOI":"10.1002\/btm2.10476"},{"key":"e_1_2_8_40_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpba.2020.113102"},{"key":"e_1_2_8_41_1","doi-asserted-by":"publisher","DOI":"10.4155\/bio-2020-0054"},{"key":"e_1_2_8_42_1","doi-asserted-by":"publisher","DOI":"10.1208\/s12248-014-9695-3"},{"key":"e_1_2_8_43_1","doi-asserted-by":"publisher","DOI":"10.1353\/dem.2007.0038"},{"key":"e_1_2_8_44_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.aca.2016.08.016"},{"key":"e_1_2_8_45_1","doi-asserted-by":"publisher","DOI":"10.1002\/9780470508183"},{"key":"e_1_2_8_46_1","doi-asserted-by":"publisher","DOI":"10.3390\/molecules28166046"},{"key":"e_1_2_8_47_1","doi-asserted-by":"publisher","DOI":"10.1002\/ansa.202300011"},{"key":"e_1_2_8_48_1","doi-asserted-by":"publisher","DOI":"10.1177\/0091270008315318"},{"key":"e_1_2_8_49_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.15832"},{"key":"e_1_2_8_50_1","doi-asserted-by":"publisher","DOI":"10.1002\/psp4.12777"},{"key":"e_1_2_8_51_1","volume-title":"NONMEM 7.5 Users Guides","author":"Beal SL SL"},{"key":"e_1_2_8_52_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cmpb.2005.04.005"},{"key":"e_1_2_8_53_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cmpb.2010.04.018"},{"key":"e_1_2_8_54_1","article-title":"Finch Studio: a next generation NONMEM modeling workbench: PAGE 30","author":"Ismail M","year":"2022","journal-title":"Abstr"},{"key":"e_1_2_8_55_1","doi-asserted-by":"publisher","DOI":"10.1038\/psp.2012.4"},{"key":"e_1_2_8_56_1","doi-asserted-by":"publisher","DOI":"10.1038\/psp.2013.14"},{"key":"e_1_2_8_57_1","doi-asserted-by":"publisher","DOI":"10.1038\/psp.2013.71"},{"key":"e_1_2_8_58_1","doi-asserted-by":"publisher","DOI":"10.1038\/psp.2013.24"},{"key":"e_1_2_8_59_1","unstructured":"Lixoft. Monolix Software. Antony France: Lixoft. Accessed January 10 2025.https:\/\/www.lixoft.com."},{"key":"e_1_2_8_60_1","doi-asserted-by":"publisher","DOI":"10.1002\/psp4.12445"},{"key":"e_1_2_8_61_1","unstructured":"R Core Team.R: A language and environment for statistical computing: R Foundation for Statistical Computing; 2020.https:\/\/www.R\u2010project.org\/"},{"key":"e_1_2_8_62_1","doi-asserted-by":"publisher","DOI":"10.12793\/tcp.2018.26.1.10"},{"key":"e_1_2_8_63_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cmpb.2010.01.007"},{"key":"e_1_2_8_64_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jbi.2008.08.010"},{"key":"e_1_2_8_65_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jbi.2019.103208"},{"key":"e_1_2_8_66_1","unstructured":"EDC C.Castor Electronic Data Capture. Amsterdam;2024.https:\/\/www.castoredc.com\/"},{"key":"e_1_2_8_67_1","unstructured":"Springer Nature.Nature announces support for authors from over 70 countries to publish open access2023.https:\/\/group.springernature.com\/gp\/group\/media\/press\u2010releases\/nature\u2010announces\u2010support\u2010for\u2010authors\u2010to\u2010publish\u2010open\u2010access\/23894926"},{"key":"e_1_2_8_68_1","unstructured":"Research4Life.Research4Life: Academic and professional content for the developing world.https:\/\/www.research4life.org\/"},{"key":"e_1_2_8_69_1","unstructured":"Radboud Universiteit.Introduction to pharmacokinetic and pharmacodynamic analysis (RSS00.01).https:\/\/www.ru.nl\/en\/education\/education\u2010for\u2010professionals\/overview\/introduction\u2010to\u2010pharmacokinetic\u2010and\u2010pharmacodynamic\u2010analysis\u2010rss0001\u2010sold\u2010out"},{"key":"e_1_2_8_70_1","unstructured":"National Institutes of Health.Principles of clinical pharmacology.https:\/\/ocreco.od.nih.gov\/courses\/principles\u2010clinical\u2010pharmacology.html"},{"key":"e_1_2_8_71_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.695"},{"key":"e_1_2_8_72_1","unstructured":"Wellcome Trust.Grant funding.https:\/\/wellcome.org\/grant\u2010funding"},{"key":"e_1_2_8_73_1","unstructured":"TDR: For research on diseases of poverty.Grants and other funding activities.https:\/\/tdr.who.int\/grants"},{"key":"e_1_2_8_74_1","unstructured":"International Union of Basic and Clinical Pharmacology (IUPHAR).Funding Requests.https:\/\/iuphar.org\/about\/funding\u2010requests\/"}],"container-title":["The Journal of Clinical Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jcph.6184","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,5,27]],"date-time":"2025-05-27T16:54:47Z","timestamp":1748364887000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/jcph.6184"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,1,14]]},"references-count":73,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2025,6]]}},"alternative-id":["10.1002\/jcph.6184"],"URL":"https:\/\/doi.org\/10.1002\/jcph.6184","archive":["Portico"],"relation":{},"ISSN":["0091-2700","1552-4604"],"issn-type":[{"value":"0091-2700","type":"print"},{"value":"1552-4604","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,1,14]]},"assertion":[{"value":"2024-09-24","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-12-18","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-01-14","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}