Aligning new interventions with developing country health systems: Target product profiles, presentation, and clinical trial design

References

• Abdulla , S. and Sagara , I. , 2009 . Dispersible formulation of artemether/lumefantrine: specifically developed for infants and young children . Malaria Journal , 8 Suppl. 1 , S7 .
   Web of Science ®Google Scholar
• Alonso , P.L. , Brown , G. , Arevalo-Herrera , M. , Binka , F. , Chitnis , C. , Collins , F. , Doumbo , O.K. , Greenwood , B. , Hall , B.F. , Levine , M.M. , Mendis , K. , Newman , R.D. , Plowe , C.V. , Rodríguez , M.H. , Sinden , R. , Slutsker , L. and Tanner , M. 2011 . A research agenda for malaria eradication: vaccines . Public Library of Science Medicine , 8 ( 1 ) : e1000398
   Google Scholar
• Andre , F.E. 1999 . Development and clinical application of new polyvalent combined paediatric vaccines . Vaccine , 17 ( 13–14 ) : 1620 – 1627 .
   PubMed Web of Science ®Google Scholar
• Bott , R.F. and Oliveira , W.P. 2007 . Storage conditions for stability testing of pharmaceuticals in hot and humid regions . Drug Development and Industrial Pharmacy , 33 ( 4 ) : 393 – 401 .
   PubMed Web of Science ®Google Scholar
• Brooks , A.D. , Wells , W.A. , McLean , T.D. , Khanna , R. , Coghlan , R. , Mertenskoetter , T. , Privor-Dumm , L.A. , Krattiger , A. , Mahoney , R.T. , and Innovation Strategy Today , 2010 . Ensuring that developing countries have access to new healthcare products: the role of product development partnerships . Innovation Strategy Today , 3 , 1 – 5 .
   Google Scholar
• Deen , J.L. and Clemens , J.D. 2006 . Issues in the design and implementation of vaccine trials in less developed countries . Nature Reviews Drug Discovery , 5 ( 11 ) : 932 – 940 .
   PubMed Web of Science ®Google Scholar
• Di Fabio , J.L. and de Quadros , C. 2001 . Considerations for combination vaccine development and use in the developing world . Clinical Infectious Diseases , 33 ( Suppl. 4 ) : S340 – S345 .
   Web of Science ®Google Scholar
• Drain , P.K. , Nelson , C.M. and Lloyd , J.S. 2003 . Single-dose versus multi-dose vaccine vials for immunization programmes in developing countries . Bulletin of the World Health Organisation , 81 ( 10 ) : 726 – 731 .
   PubMed Web of Science ®Google Scholar
• Ellis , R.W. 2001 . Product development plan for new vaccine technologies . Vaccine , 19 ( 13–14 ) : 1559 – 1566 .
   PubMed Web of Science ®Google Scholar
• Food and Drug Administration , 2007 . DRAFT guidance for industry and review staff. Target product profile – a strategic development process tool . Washington , DC : US Department of Health and Human Services .
   Google Scholar
• Frost , L.J. and Reich , M.R. 2008 . Access: how do good health technologies get to the poor people in poor countries? , Cambridge , MA : Harvard Center for Population and Development Studies .
   Google Scholar
• Garg , S. , Tambwekar , K.R. , Vermani , K. , Kandarapu , R. , Garg , A. , Waller , D.P. and Zaneveld , L.J. 2003 . Development pharmaceutics of microbicide formulations. Part II: formulation, evaluation, and challenges . AIDS Patient Care STDS , 17 ( 8 ) : 377 – 399 .
   PubMed Web of Science ®Google Scholar
• Garnett , A. , 2007 . Vaccine Presentation Assessment Tool [online]. Available from: http://www.technet21.org/index.php/tools/view-document-details/1086-vaccine-presentation-assessment-tool-vpat-program-files.html [Accessed 26 May 2011] .
   Google Scholar
• George Institute for International Health , 2009 . The G-FINDER report: neglected disease research and development: new times, new trends [online]. Available from: https://studies.thegeorgeinstitute.org/g-finder/index.jsp [Accessed 26 May 2011] .
   Google Scholar
• Kerdpanich , A. , Chokephaibulkit , K. , Watanaveeradej , V. , Vanprapar , N. , Simasathien , S. , Phavichitr , N. , Bock , H.L. , Damaso , S. , Hutagalung , Y. and Han , H.H. 2011 . Immunogenicity of a human rotavirus vaccine (RIX4414) after storage at 37 degrees C for seven days . Human Vaccines , 7 ( 1 ) : 74 – 80 .
   PubMed Web of Science ®Google Scholar
• Lambert , W.J. 2010 . Considerations in developing a target product profile for parenteral pharmaceutical products . American Association of Pharmaceutical Scientists PharmSciTech , 11 ( 3 ) : 1476 – 1481 .
   Google Scholar
• Lee , B.Y. and Burke , D.S. 2010 . Constructing target product profiles (TPPs) to help vaccines overcome post-approval obstacles . Vaccine , 28 ( 16 ) : 2806 – 2809 .
   PubMed Web of Science ®Google Scholar
• Lee , B.Y. and McGlone , S.M. 2010 . Pricing of new vaccines . Human Vaccines , 6 ( 8 ) : 619 – 626 .
   PubMed Web of Science ®Google Scholar
• Mahoney , R.T. , Krattiger , A. , Clemens , J.D. and Curtiss , R. III . 2007 . The introduction of new vaccines into developing countries. IV: global access strategies . Vaccine , 25 ( 20 ) : 4003 – 4011 .
   PubMed Web of Science ®Google Scholar
• Mangtani , P.K. , Mulholland , K. , Madhi , S.A. , Edmond , K. , O'Loughlin , R. and Hajjeh , R. 2010 . Haemophilus influenzae type b disease in HIV-infected children: a review of the disease epidemiology and effectiveness of Hib conjugate vaccines . Vaccine , 28 ( 7 ) : 1677 – 1683 .
   PubMed Web of Science ®Google Scholar
• Milstien , J. , Cohen , J. , and Olsen I.T. , 2007 . An evaluation of the GAVI Alliance efforts to introduce new vaccines via the Accelerated Development and Introduction Plans (ADIPs) and the Hib Initiative (HI) [online]. Available from: http://www.norad.no/en/Tools + and + publications/Publications/Publication + Page?key=109787 [Accessed 26 May 2011] .
   Google Scholar
• Milstien , J. , Cárdenas , V. , Cheyne , J. and Brooks , A. 2010 . WHO policy development processes for a new vaccine: case study of malaria vaccines . Malaria Journal , 9 : 182
   PubMed Web of Science ®Google Scholar
• Moon , S.S. , Wang , Y. , Shane , A.L. , Nguyen , T. , Ray , P. , Dennehy , P. , Baek , L.J. , Parashar , U. , Glass , R.I. and Jiang , B. 2010 . Inhibitory effect of breast milk on infectivity of live oral rotavirus vaccines . The Pediatric Infectious Disease Journal , 29 ( 10 ) : 919 – 923 .
   PubMed Web of Science ®Google Scholar
• Moorthy , V. , Reed , Z. and Smith , P.G. 2007 . Measurement of malaria vaccine efficacy in phase III trials: report of a WHO consultation . Vaccine , 25 ( 28 ) : 5115 – 5123 .
   PubMedGoogle Scholar
• Moorthy , V. , Reed , Z. and Smith , P.G. 2009 . MALVAC 2008: measures of efficacy of malaria vaccines in phase 2b and phase 3 trials—scientific, regulatory and public health perspectives . Vaccine , 27 ( 5 ) : 624 – 628 .
   PubMed Web of Science ®Google Scholar
• Obrist , B. , Iteba , N. , Lengeler , C. , Makemba , A. , Mshana , C. , Nathan , R. , Alba , S. , Dillip , A. , Hetzel , M.W. , Mayumana , I. , Schulze , A. and Mshinda , H. 2007 . Access to health care in contexts of livelihood insecurity: a framework for analysis and action . Public Library of Science Medicine , 4 ( 10 ) : 1584 – 1588 .
   Google Scholar
• Ojakaa , D.I. , Ofware , P. , Machira , Y.W. , Yamo , E. , Collymore , Y. , Ba-Nguz , A. , Vansadia , P. and Bingham , A. 2011 . Community perceptions of malaria and vaccines in South Coast and Busia regions of Kenya . Malaria Journal , 10 : 147
   PubMed Web of Science ®Google Scholar
• PATH , 2007 . Vaccine presentation for pneumococcal vaccines: WHO consultation for the development of a TPP for pneumococcal vaccines [online]. Available from: http://sites.google.com/site/vppagp/Home/pneumo-tpp [Accessed 26 May 2011] .
   Google Scholar
• PATH , 2008 . Public-sector preferences for RTS,S/AS01 malaria vaccine formulation, presentation, and packaging [online]. Available from: http://www.technet21.org/index.php/documents/view-document/715-public-sector-preferences-for-rtss/as01-malaria-vaccine-formulation-presentation-and-packaging.html [Accessed 26 May 2011] .
   Google Scholar
• PATH Malaria Vaccine Initiative , 2011 . Malaria vaccine decision-making framework [online]. Available from: www.malvacdecision.net [Accessed 26 May 2011] .
   Google Scholar
• Raw , A.S. , Lionberger , R. , and Yu , L.X. , 2011 . Pharmaceutical equivalence by design for generic drugs: modified-release products. Pharmaceutical Research [online]. Available from: http://www.springerlink.com/content/0769h86828j7u76w/ [Accessed 26 May 2011] .
   Google Scholar
• Roth , A.H. , Jensen , H. , Garly , M.L. , Djana , Q. , Martins , C.L. , Sodemann , M. , Rodrigues , A. and Aaby , P. 2004 . Low birth weight infants and Calmette-Guerin bacillus vaccination at birth: community study from Guinea-Bissau . Pediatric Infectious Disease Journal , 23 ( 6 ) : 544 – 550 .
   PubMed Web of Science ®Google Scholar
• RTS,S Clinical Trials Partnership , 2011 . First results of phase 3 trial of RTS,S/AS01 malaria vaccine in African children . New England Journal of Medicine , 365 20 , 1863 – 1875 .
   PubMed Web of Science ®Google Scholar
• Sartori , A.M. 2004 . A review of the varicella vaccine in immunocompromised individuals . International Journal of Infectious Dieases , 8 ( 5 ) : 259 – 270 .
   Web of Science ®Google Scholar
• Schreuder , B. , Arentsen , H. and Matosse , M. 1997 . How important are airfreight rates and vaccine packaging in cost-saving efforts for the Expanded Programme on Immunization? . Bulletin of the World Health Organisation , 75 ( 4 ) : 315 – 321 .
   PubMed Web of Science ®Google Scholar
• Shann , F. , Nohynek , H. , Scott , J.A. , Hesseling , A. , Flanagan , K.L. and Working Group on Nonspecific Effects of Vaccines , 2010 . Randomized trials to study the nonspecific effects of vaccines in children in low-income countries . Pediatric Infectious Disease Journal , 29 5 , 457 – 461 .
   PubMed Web of Science ®Google Scholar
• Steele , A.D. , Cunliffe , N. , Tumbo , J. , Madhi , S.A. , De Vos , B. and Bouckenoogghe , A. 2009 . A review of rotavirus infection in and vaccination of human immunodeficiency virus-infected children . Journal of Infectious Diseases , 200 ( Suppl. 1 ) : S57 – S62 .
   PubMed Web of Science ®Google Scholar
• Tebbey , P.W. and Rink , C. 2009 . Target product profile: a renaissance for its definition and use . Journal of Medical Marketing , 9 ( 4 ) : 301 – 307 .
   Google Scholar
• Vaccine Presentation and Packaging Advisory Group , 2009 . Generic preferred product profile for vaccines, Version 2.1 [online]. Available from: http://sites.google.com/site/vppagp/gppp [Accessed 26 May 2011] .
   Google Scholar
• Vekemans , J. , Leach , A. and Cohen , J. 2009 . Development of the RTS,S/AS malaria candidate vaccine . Vaccine , 27 ( Suppl. 6 ) : G67 – G71 .
   Web of Science ®Google Scholar
• WHO , 2000 . WHO policy statement: the use of opened multi-dose vials of vaccine in subsequent immunization session . WHO/V&B/00.0. 2000 .
   Google Scholar
• WHO , 2005 . Vaccine introduction guidelines: adding a vaccine to a national immunization programme: decision and implementation . WHO/IVB/05.18 .
   Google Scholar
• Yu , L.X. 2008 . Pharmaceutical quality by design: product and process development, understanding, and control . Pharmaceutical Research , 25 ( 4 ) : 781 – 791 .
   PubMed Web of Science ®Google Scholar