Developing countries efficacy studies

Generally, in most developing countries, dmg regulation is very weak, and the safety, efficacy and quality of imported or locally manufactured dmgs cannot, therefore, be assured. Studies carried out in some countries show that about 20% of tested dmg products fail to meet quality standards. Reports have also shown that the prevalence of substandard and counterfeit dmgs is higher in countries where dmg regulation is ineffective. 

Medicinal plants can offer alternative remedies with tremendous opportunities compared to synthetic modem pharmaceuticals. They not oidy provide access and affordable medicine to poor people they can also generate income, employment and foreign exchange for developing countries. Many traditional healing herbs and plant parts have been shown to have medicinal value, especially in the rural areas and these can be used to prevent, alleviate or cure several human diseases. The safety of raw medicinal plant materials clearly provides a compelling rational for both additional scientific study and national health care pohcies that can address the judicious use of traditional medicines to improve the quality and quantity of these materials and to ensure their efficacy. 

Two second-generation rotavirus vaccine candidates (one composed of five human-animal reassortants, RotaTeq , and the other a monovalent attenuated human rotavirus vaccine, Rotarix ) were in development in 1999, and after 7 years of study, they were licensed by the European Medicines Agency (EMA), the Food and Drug Administration (FDA), and many other licensing authorities. Both vaccines are efficacious and both underwent extensive safety trials in more than 130000 children, in whom there was no association with intussusception. In the years since licensing, there have been substantial reductions in the rates of hospitalization and death from rotavirus in both developed and less-developed countries. As part of post-licensing safety follow-up, the possible effect of the widespread use of rotavirus vaccines on rates of intussusception has been monitored carefully [2V]. 

Since alternative methods to animal testing should be used for cosmetics, according to the guidelines and/or rules set out in the legislation of most countries (see Section 1.1), to develop in vitro methods for efficacy studies constitutes an authentic challenge. Moreover, invasive in vivo techniques using human volunteers (such as the sun protection factor estimation by UV irradiation methods that was commented in Section 3.1) should also be changed for non-invasive ex vivo techniques or for in vitro methods. 

GS-13529, terbuthylazine A chlorotriazine similar to atrazine and simazine, terbuthylazine was first introduced to the scientific community in 1966. Terbuthylazine also provided broad-spectrum weed control in com. Studies comparing efficacy showed that generally atrazine was more effective than terbuthylazine on both broadleaf and grassy weeds. Since terbuthylazine was less efficacious than atrazine in weed control trials conducted in the United States in the late 1960s, it was not commercially developed for com in the United States. However, development for use in corn and vines continued for Europe and other countries where the weed control needs differed and the weed control differences between atrazine and terbuthylazine were not limiting. 

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