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Aligning new interventions with developing country health systems: Target product profiles, presentation, and clinical trial design.
Global Public Health. 2012 Oct; 7(9):931-945.Many new interventions are being created to address health problems of the developing world. However, many developing countries have fragile health systems and find it difficult to accommodate change. Consequently, it is essential that new interventions are well aligned with health systems and their users. Establishing target product profiles (TPPs) is a critical, early step towards tailoring interventions to suit both of these constituencies. Specific analyses can help identify and establish relevant TPP criteria such as optimal formulation, presentation and packaging. Clinical trials for a new intervention should be designed to address both TPP-specific questions and anticipated use of the intervention in target countries. Examples are provided from research on malaria vaccines that are also applicable to other new public health interventions.
Bethesda, Maryland, Abt Associates, Partners for Health Reform Plus Project, 2004 Aug.  p. (USAID Contract No. HRN-C-00-00-00019-00)The United States Agency for International Development invited the Partners for Health Reformplus to estimate costs associated with the packaging of infant doses of Nevirapine in Zambia. The costs of following four scenarios were examined in this exercise: 1) preparation and administration of Nevirapine by a nurse immediately after birth, 2) preparation of Nevirapine in batches prepared by either a nurse or nurse’s aide, 3) a semi-automated approach of pre-filled and packaged Nevirapine syringes, and 4) a fully automated approach using UnijectDP pre-filled with Nevirapine. Findings show that, at all dose levels, administration by a nurse after birth is the most cost-effective scenario. However, if other important factors, such as limited access to hospital facilities, are taken into consideration, then the semi-automated or Uniject approaches may be more suitable. (author's)
BMJ. British Medical Journal. 1982 Feb 6; 284(6313):422.The report by Mr. R.A. Fay (January 2, p. 17) about the new triphasic oral contraceptive (OC) Logynon is disturbing. I wish to draw attention to another aspect of this preparation--that of possible failure in the 1st course and the lack of instructions to the patient to use additional contraceptive precautions when starting Loygnon. An 18-year-old patient of mine, who had not previously used a contraceptive, started Logynon on the 1st day of menstruation, as recommended. This period lasted 5 days and was entirely normal. She completed a 21-day course without omitting any tablets and without having any gastrointestinal disturbance. This course was followed by amenorrhea. When seen 10 days later she was found to have a normal-sized uterus and an equivocal result in the Gravindex pregnancy test. After a further 10 days she noted symptoms of pregnancy and was found to have uterine enlargement and was definitely positive in the Gravindex test. It seems most probable that this girl became pregnant during the 1st course of Logynon. I do not doubt that she took the course conscientiously. I am concerned because when this triphasic preparation was first launched I understood that additional contraceptive precautions were not necessary when Logynon was started, if the course was started on the 1st day of the period. This would be consistent with the findings of suppression of midcycle gonadotropins and estradiol and late-cycle progesterone from the 1st treatment cycle. The instruction leaflet for patients does not advocate additional precautions unless the woman is changing from another OC and starting on the 5th day of menstruation. With monophasic contraceptives marketed by Schering, the need for additional precautions in the 1st 14 days after starting the pill is clearly stated in the instruction leaflet. If other similar instances of pill failure have been noted when the woman has been starting Logynon, perhaps the instruction leaflet should recommend additional contraceptive measures for the first 2-3 weeks. (full text)