{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,8]],"date-time":"2026-09-08T12:48:27Z","timestamp":1788871707501,"version":"build-2803163510"},"reference-count":44,"publisher":"Elsevier BV","issue":"4","license":[{"start":{"date-parts":[[2013,4,1]],"date-time":"2013-04-01T00:00:00Z","timestamp":1364774400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2013,4,1]],"date-time":"2013-04-01T00:00:00Z","timestamp":1364774400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"}],"funder":[{"DOI":"10.13039\/100000865","name":"Bill and Melinda Gates Foundation","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000865","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["clinicalkey.com","clinicalkey.com.au","clinicalkey.es","clinicalkey.fr","clinicalkey.jp","contraceptionjournal.org","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Contraception"],"published-print":{"date-parts":[[2013,4]]},"DOI":"10.1016\/j.contraception.2012.07.010","type":"journal-article","created":{"date-parts":[[2012,8,23]],"date-time":"2012-08-23T20:46:50Z","timestamp":1345754810000},"page":"473-479","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":0,"title":["Development and implementation of a quality assurance program for a hormonal contraceptive implant"],"prefix":"10.1016","volume":"87","author":[{"given":"Derek H.","family":"Owen","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Jenkins","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aida","family":"Cancel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eli","family":"Carter","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laneta","family":"Dorflinger","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeff","family":"Spieler","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Markus J.","family":"Steiner","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1016\/j.contraception.2012.07.010_bb0005","article-title":"Pharmerging shake-up: new imperatives in a redefined world","author":"Campbell","year":"2010","journal-title":"IMS Health"},{"key":"10.1016\/j.contraception.2012.07.010_bb0010","unstructured":"Moran M, Guzman J, McDonald A, Wu L, Omune B. Registering new drugs: the African context: new tools for new times. Health Policy Division, George Inst Int Health 2010; January."},{"key":"10.1016\/j.contraception.2012.07.010_bb0015","first-page":"128","article-title":"Regulatory pathways for vaccines for developing countries","volume":"82","author":"Milstien","year":"2004","journal-title":"B World Health Organ"},{"key":"10.1016\/j.contraception.2012.07.010_bb0020","first-page":"207","article-title":"The need to reform current drug registration processes to improve access to essential medicines in developing countries","volume":"22","author":"van Roey","year":"2008","journal-title":"Int J Pharm Med"},{"key":"10.1016\/j.contraception.2012.07.010_bb0025","doi-asserted-by":"crossref","first-page":"494","DOI":"10.1038\/sj.clpt.6100493","article-title":"The effect of globalization of drug manufacturing, production, and sourcing and challenges for American drug safety","volume":"83","author":"Woo","year":"2008","journal-title":"Clin Pharmacol Ther"},{"key":"10.1016\/j.contraception.2012.07.010_bb0030","doi-asserted-by":"crossref","first-page":"1044","DOI":"10.1136\/bmj.330.7499.1044-d","article-title":"WHO combats counterfeit malaria drugs in Asia","volume":"330","author":"Parry","year":"2005","journal-title":"Br Med J"},{"key":"10.1016\/j.contraception.2012.07.010_bb0035","doi-asserted-by":"crossref","first-page":"88","DOI":"10.1016\/j.contraception.2010.06.016","article-title":"The promise of affordable implants: is cost-recovery possible in Kenya?","volume":"83","author":"Tumlinson","year":"2011","journal-title":"Contraception"},{"key":"10.1016\/j.contraception.2012.07.010_bb0040","doi-asserted-by":"crossref","first-page":"1630","DOI":"10.1126\/science.1197080","article-title":"Family planning and the Millennium Development Goals","volume":"329","author":"Cates","year":"2010","journal-title":"Science"},{"key":"10.1016\/j.contraception.2012.07.010_bb0045","series-title":"Rwanda Interim Demographic and Health Survey 2007\u201308","author":"Ministry of Health (MOH) [Rwanda]","year":"2009"},{"key":"10.1016\/j.contraception.2012.07.010_bb0050","series-title":"Enqu\u00eate D\u00e9mographique et de Sant\u00e9 de Madagascar 2008\u20132009","author":"Institut National de la Statistique (INSTAT) et ICF Macro","year":"2010"},{"key":"10.1016\/j.contraception.2012.07.010_bb0055","doi-asserted-by":"crossref","first-page":"468","DOI":"10.1016\/j.contraception.2007.02.008","article-title":"Contraceptive implants in Kenya: current status and future prospects","volume":"75","author":"Hubacher","year":"2007","journal-title":"Contraception"},{"key":"10.1016\/j.contraception.2012.07.010_bb0060","doi-asserted-by":"crossref","first-page":"197","DOI":"10.1016\/j.contraception.2009.10.013","article-title":"Sino-Implant (II) \u2014 a levonorgestrel-releasing two-rod implant: systematic review of the randomized controlled trials","volume":"81","author":"Steiner","year":"2010","journal-title":"Contraception"},{"key":"10.1016\/j.contraception.2012.07.010_bb0065","doi-asserted-by":"crossref","first-page":"140","DOI":"10.1016\/j.contraception.2009.08.006","article-title":"Assessment of a disposable trocar for insertion of contraceptive implants","volume":"81","author":"Steiner","year":"2010","journal-title":"Contraception"},{"key":"#cr-split#-10.1016\/j.contraception.2012.07.010_bb0070.1","unstructured":"(a) United States Pharmacopeia and National Formulary (USP 31-NF 26). Vol 2. Rockville, MD: United States Pharmacopeia Convention; 2008: 2521 (Monograph for Levonorgestrel)."},{"key":"#cr-split#-10.1016\/j.contraception.2012.07.010_bb0070.2","unstructured":"(b) United States Pharmacopeia and National Formulary (USP 32-NF 27). Vol 2. Rockville, MD: United States Pharmacopeia Convention; 2009: 2774. (Monograph for Levonorgestrel)."},{"key":"10.1016\/j.contraception.2012.07.010_bb0075","unstructured":"Pharmacopeia of The People's Republic of China, Chinese Pharmacopeia Commission; 2005 Vol II, (Monograph for Levonorgestrel)."},{"key":"#cr-split#-10.1016\/j.contraception.2012.07.010_bb0080.1","unstructured":"(a) British Pharmacopeia. London, UK: British Pharmacopeia Commission Office; 2010 Vol 2, (Monograph for Levonorgestrel)."},{"key":"#cr-split#-10.1016\/j.contraception.2012.07.010_bb0080.2","unstructured":"(b) British Pharmacopeia. London, UK: British Pharmacopeia Commission Office; 2011 Vol 2, (Monograph for Levonorgestrel)."},{"key":"10.1016\/j.contraception.2012.07.010_bb0085","author":"Q3A(R2): Impurities in new drug substances"},{"key":"10.1016\/j.contraception.2012.07.010_bb0090","author":"Q3B(R2): Impurities in new drug products"},{"key":"10.1016\/j.contraception.2012.07.010_bb0095","author":"Q3C(R5): Impurities: guideline for residual solvents"},{"key":"10.1016\/j.contraception.2012.07.010_bb0100","unstructured":"ISO 10993-07:2008, Biological evaluation of medical devices\u2014Part 7: ethylene oxide sterilization residuals. http:\/\/www.iso.org\/iso\/home\/store\/catalogue_tc\/catalogue_detail.htm?csnumber=34213."},{"key":"#cr-split#-10.1016\/j.contraception.2012.07.010_bb0105.1","unstructured":"(a) United States Pharmacopeia and National Formulary (USP 31-NF 26). Vol 1. Rockville, MD: United States Pharmacopeia Convention; 2008: 287-292 (General Chapter <730> Plasma Spectrochemistry)."},{"key":"#cr-split#-10.1016\/j.contraception.2012.07.010_bb0105.2","unstructured":"(b) United States Pharmacopeia and National Formulary (USP 32-NF-27). Vol 1. Rockville, MD: United States Pharmacopeia Convention; 2009: 285-290 (General Chapter <730> Plasma Spectrochemistry)."},{"key":"#cr-split#-10.1016\/j.contraception.2012.07.010_bb0105.3","unstructured":"(c) United States Pharmacopeia and National Formulary (USP 33-NF-28). Vol 1. Rockville, MD: United States Pharmacopeia Convention; 2010: 285-290 (General Chapter <730> Plasma Spectrochemistry)."},{"key":"#cr-split#-10.1016\/j.contraception.2012.07.010_bb0105.4","unstructured":"(d) United States Pharmacopeia and National Formulary (USP 34-NF-29). Vol 1. Rockville, MD: United States Pharmacopeia Convention; 2011: 299-304 (General Chapter <730> Plasma Spectrochemistry)."},{"key":"10.1016\/j.contraception.2012.07.010_bb0110","unstructured":"Cyanta Analytical Laboratories \u2014 Report R080806A, Trace metal analysis of polydimethylsiloxane implants."},{"key":"#cr-split#-10.1016\/j.contraception.2012.07.010_bb0115.1","unstructured":"(a) United States Pharmacopeia and National Formulary (USP 31-NF 26). Vol 1. Rockville, MD: United States Pharmacopeia Convention; 2008: 170-181 (General Chapter <467> Residual Solvents)."},{"key":"#cr-split#-10.1016\/j.contraception.2012.07.010_bb0115.2","unstructured":"(b) United States Pharmacopeia and National Formulary (USP 32-NF-27). Vol 1. Rockville, MD: United States Pharmacopeia Convention; 2009: 163-175 (General Chapter <467> Residual Solvents)."},{"key":"#cr-split#-10.1016\/j.contraception.2012.07.010_bb0115.3","unstructured":"(c) United States Pharmacopeia and National Formulary (USP 33-NF-28). Vol 1. Rockville, MD: United States Pharmacopeia Convention; 2010: 163-175 (General Chapter <467> Residual Solvents)."},{"key":"#cr-split#-10.1016\/j.contraception.2012.07.010_bb0115.4","unstructured":"(d) United States Pharmacopeia and National Formulary (USP 34-NF-29). Vol 1. Rockville, MD: United States Pharmacopeia Convention; 2011: 171-182 (General Chapter <467> Residual Solvents)."},{"key":"#cr-split#-10.1016\/j.contraception.2012.07.010_bb0120.1","unstructured":"(a) United States Pharmacopeia and National Formulary (USP 31-NF 26). Vol 1. Rockville, MD: United States Pharmacopeia Convention; 2008: 98-102 (General Chapter <85> Bacterial Endotoxins Test)."},{"key":"#cr-split#-10.1016\/j.contraception.2012.07.010_bb0120.2","unstructured":"(b) United States Pharmacopeia and National Formulary (USP 32-NF-27). Vol 1. Rockville, MD: United States Pharmacopeia Convention; 2009: 93-96 (General Chapter <85> Bacterial Endotoxins Test)."},{"key":"#cr-split#-10.1016\/j.contraception.2012.07.010_bb0120.3","unstructured":"(c) United States Pharmacopeia and National Formulary (USP 33-NF-28). Vol 1. Rockville, MD: United States Pharmacopeia Convention; 2010: 97-101 (General Chapter <85> Bacterial Endotoxins Test)."},{"key":"#cr-split#-10.1016\/j.contraception.2012.07.010_bb0120.4","unstructured":"(d) United States Pharmacopeia and National Formulary (USP 34-NF-29). Vol 1. Rockville, MD: United States Pharmacopeia Convention; 2011: 78-87 (General Chapter <85> Bacterial Endotoxins Test)."},{"key":"#cr-split#-10.1016\/j.contraception.2012.07.010_bb0125.1","unstructured":"(a) United States Pharmacopeia and National Formulary (USP 31-NF 26). Vol 1. Rockville, MD: United States Pharmacopeia Convention; 2008: 102-103 (General Chapter <87> Biological Reactivity Tests, In Vitro)."},{"key":"#cr-split#-10.1016\/j.contraception.2012.07.010_bb0125.2","unstructured":"(b) United States Pharmacopeia and National Formulary (USP 32-NF-27). Vol 1. Rockville, MD: United States Pharmacopeia Convention; 2009: 97-98 (General Chapter <87> Biological Reactivity Tests, In Vitro)."},{"key":"#cr-split#-10.1016\/j.contraception.2012.07.010_bb0125.3","unstructured":"(c) United States Pharmacopeia and National Formulary (USP 33-NF-28). Vol 1. Rockville, MD: United States Pharmacopeia Convention; 2010: 97-98 (General Chapter <87> Biological Reactivity Tests, In Vitro)."},{"key":"#cr-split#-10.1016\/j.contraception.2012.07.010_bb0125.4","unstructured":"(d) United States Pharmacopeia and National Formulary (USP 34-NF-29). Vol 1. Rockville, MD: United States Pharmacopeia Convention; 2011: 82-83 (General Chapter <87> Biological Reactivity Tests, In Vitro)."},{"key":"#cr-split#-10.1016\/j.contraception.2012.07.010_bb0130.1","unstructured":"(a) United States Pharmacopeia and National Formulary (USP 31-NF 26). Vol 1. Rockville, MD: United States Pharmacopeia Convention; 2008: 251-255 (General Chapter <661> Containers-Plastics)."},{"key":"#cr-split#-10.1016\/j.contraception.2012.07.010_bb0130.2","unstructured":"(b) United States Pharmacopeia and National Formulary (USP 32-NF-27). Vol 1. Rockville, MD: United States Pharmacopeia Convention; 2009: 246-250 (General Chapter <661> Containers-Plastics)."},{"key":"#cr-split#-10.1016\/j.contraception.2012.07.010_bb0130.3","unstructured":"(c) United States Pharmacopeia and National Formulary (USP 33-NF-28). Vol 1. Rockville, MD: United States Pharmacopeia Convention; 2010: 246-250 (General Chapter <661> Containers-Plastics)."},{"key":"#cr-split#-10.1016\/j.contraception.2012.07.010_bb0130.4","unstructured":"(d) United States Pharmacopeia and National Formulary (USP 34-NF-29). Vol 1. Rockville, MD: United States Pharmacopeia Convention; 2011: 258-263 (General Chapter <661> Containers-Plastics)."},{"key":"10.1016\/j.contraception.2012.07.010_bb0135","unstructured":"ASTM F2096-04 \u2014 Standard test method for detecting gross leaks in medical packaging by internal pressurization (bubble test). http:\/\/www.astm.org\/Standards\/F2096.htm."}],"container-title":["Contraception"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0010782412006762?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0010782412006762?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2025,9,14]],"date-time":"2025-09-14T20:11:02Z","timestamp":1757880662000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0010782412006762"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2013,4]]},"references-count":44,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2013,4]]}},"alternative-id":["S0010782412006762"],"URL":"https:\/\/doi.org\/10.1016\/j.contraception.2012.07.010","relation":{},"ISSN":["0010-7824"],"issn-type":[{"value":"0010-7824","type":"print"}],"subject":[],"published":{"date-parts":[[2013,4]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Development and implementation of a quality assurance program for a hormonal contraceptive implant","name":"articletitle","label":"Article Title"},{"value":"Contraception","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.contraception.2012.07.010","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"Copyright \u00a9 2013 Elsevier Inc. Published by Elsevier Inc. All rights reserved.","name":"copyright","label":"Copyright"}]}}