References by module
- Introduction
- Trial design
- Pharmacokinetic modelling
- Pregnant and breastfeeding women
- Coinfections
- Acceptability
- Community engagement
- Target product profiles
- Product commercialization
- Regulatory filing
- Pharmacovigilance
- Conclusion
Introduction
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Trial design
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2. Penazzato M, Gnanashanmugam M, Rojo P, et al. Optimizing Research to Speed Up Availability of Pediatric Antiretroviral Drugs and Formulations. Clinical Infectious Diseases. 2017;64:1597-1603.
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Pharmacokinetic modelling
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Community engagement
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Target product profiles
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17. Clarke DF, Penazzato M, Capparelli E, Cressey TR, Siberry G, Sugandhi N et al. Prevention and treatment of HIV infection in neonates: evidence base for existing WHO dosing recommendations and implementation considerations. Expert Rev Clin Pharmacol. 2018;11:83–93.
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28. Simon A, Warszawski J, Kariyawasam D, Le Chenadec J, Benhammou V, Czernichow P et al. Association of prenatal and postnatal exposure to lopinavir-ritonavir and adrenal dysfunction among uninfected infants of HIV-infected mothers. JAMA. 2011;306:70–8.
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Product commercialization
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2. A super-Fast Track framework for ending AIDS in children, adolescents and young women by 2020. Geneva: UNAIDS; 2018 (https://free.unaids.org, accessed 22 May 2018).
3. Paediatric HIV/AIDS project. Paris: Unitaid; 2015 (https://unitaid.eu/project/paediatric-hiv-aids-project/#en, accessed 22 May 2018).
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5. Penazzato M, Lee J, Capparelli E, Essajee S, Ford N, Ojoo A et al. Optimizing drugs to reach treatment targets for children and adolescents living with HIV. J Int AIDS Soc. 2015;18:20270.
6. Interagency Task Team on Prevention and Treatment of HIV Infection in Pregnant Women, Mothers and Children. Update to the optimal list of paediatric ARV formulations. IATT meeting report. Geneva: World Health Organization; 2013 (http://apps.who.int/medicinedocs/en/m/abstract/Js21435en, accessed 22 May 2018).
7. Interagency Task Team on Prevention and Treatment of HIV Infection in Pregnant Women, Mothers and Children. Update to the optimal list of paediatric ARV formulations. Geneva: World Health Organization; 2015 (http://apps.who.int/medicinedocs/en/m/abstract/Js22094en, accessed 22 May 2018).
8. Interagency Task Team on Prevention and Treatment of HIV Infection in Pregnant Women, Mothers and Children. 2016 IATT paediatric ARV formulary and limited-use list: 2016 update. Geneva: World Health Organization; 2016 (http://apps.who.int/medicinedocs/documents/s23120en/s23120en.pdf, accessed 22 May 2018).
9. Prabhu VR, McGovern S, Domanico P. Estimating the size of the pediatric antiretroviral (ARV) market in 26 low- and middle-income countries (low- and middle-income countries) through 2025 as prevention of mother to child transmission (PMTCT) initiatives continue to succeed. 9th IAS Conference on HIV Science, 23–26 July 2017, Paris, France (Abstract WEAD0203; http://programme.ias2017.org/Abstract/Abstract/2724, accessed 22 May 2018).
10. Consolidated guidelines on the use of antiretroviral drugs for treating and prevention HIV infection: recommendations for a public health approach. 2nd ed. Geneva: World Health Organization; 2016 (http://www.who.int/hiv/pub/arv/arv-2016/en, accessed 22 May 2018).
11. Tentative approval for abacavir and lamvidine tablets for oral suspension, 120mg/60mg. Washington (DC): United States Department of Health and Human Services; 2014 (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204915Orig1s000TAltr.pdf, accessed 22 May 2018).
12. ARV Procurement Working Group. Anticipated demand forecast. Geneva: Global Fund to Fight AIDS, Tuberculosis and Malaria; 2018 (https://www.theglobalfund.org/media/6589/psm_arvprocurementworkinggroupanticipateddemandforecast_table_en.pdf, accessed 22 May 2018).
13. New product introduction toolkit. Washington (DC): Clinton Health Access Initiative; 2017 (https://www.newhivdrugs.org, accessed 22 May 2018).
Regulatory filing
1. Draft guidance for industry: pediatric study plans: content of and process for submitting initial pediatric study plans and amended initial pediatric study plans: guidance for industry. Washington (DC): United States Food and Drug Administration; 2016 (https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm360507.pdf, accessed 22 May 2018).
2. Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004. Brussels: European Commission; 2006 (https://ec.europa.eu/health//sites/health/files/files/eudralex/vol-1/reg_2006_1901/reg_2006_1901_en.pdf, accessed 22 May 2018).
3. Regulation (EC) No 1902/2006 of the European Parliament and of the Council of 20 December 2006 amending Regulation 1901/2006 on medicinal products for paediatric use. Brussels: European Commission; 2006 (https://ec.europa.eu/health//sites/health/files/files/eudralex/vol-1/reg_2006_1902/reg_2006_1902_en.pdf, accessed 22 May 2018).
4. Information from European Union institutions, bodies, offices and agencies. Guideline on the format and content of applications for agreement or modification of a paediatric investigation plan and requests for waivers or deferrals and concerning the operation of the compliance check and on criteria for assessing significant studies. Brussels: European Commission; 2014 (https://ec.europa.eu/health//sites/health/files/files/eudralex/vol-1/2014_c338_01/2014_c338_01_en.pdf, accessed 22 May 2018).
5. Principles of interactions: between EMEA and FDA pediatric therapeutics. London: European Medicines Agency; 2007 (http://www.ema.europa.eu/docs/en_GB/document_library/Other/2009/12/WC500017969.pdf, accessed 22 May 2018).
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7. Getting started with the division of antiviral products pre-investigational new drug process. Washington (DC): United States Food and Drug Administration; 2017 (https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugInewdrug applicationpplication/Overview/ucm077546.htm, accessed 22 May 2018).
8. Division of Anti-Viral Products' (DAVP) pre-investigational new drug letter of instruction. Washington (DC): United States Food and Drug Administration; 2016 (https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/Overview/ucm077776.htm, accessed 22 May 2018).
9. Article 58 applications: regulatory and procedural guidance. London: European Medicines Agency; 2016 (http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000157.jsp&mid=WC0b01ac05800240d1, accessed 22 May 2018).
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16. Guidance for industry: prescription drug user fee act waivers for fixed combination antiretroviral drugs for the President’s Emergency Plan for AIDS Relief. Washington (DC): United States Food and Drug Administration; 2018 (https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm610019.pdf, accessed 22 May 2018).
17. Support for applications on Article 58. London: European Medicines Agency; 2017 (http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2017/02/WC500221119.pdf, accessed 22 May 2018).
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20. Annex to WHO prequalification fees. Geneva: World Health Organization; 2016 (http://apps.who.int/medicinedocs/documents/s20307en/s20307en.pdf, accessed 22 May 2018).
Pharmacovigilance
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