Transcription of MODULE 7: TARGET PRODUCT PROFILES
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MODULE 7: TARGET PRODUCT PROFILES
MODULE 7: TARGET PRODUCT . PROFILES . DNDi/Scholars & Gentlemen 126. 1. INTRODUCTION. TARGET PRODUCT PROFILES are key strategic The global community, including WHO, UNAIDS, documents used to communicate summary the Global Fund to Fight AIDS, Tuberculosis requirements for new products that fulfil a and Malaria (Global Fund), the United States priority need. The purpose of TARGET PRODUCT President's Emergency Plan for AIDS Relief PROFILES is to guide industry during the drug (PEPFAR) and the United Nations Children's Fund development process and serve as a planning (UNICEF), have a responsibility to define the tool that can facilitate discussions with requirements around paediatric medicines and regulatory agencies and be updated as new have clear, transparent communication to industry information becomes available. on the products that are required to meet the unique needs of children.
Syrups Younger age group (unable to swallow) In principle, easy to manufacture Soluble, chemically stable Difficult Difficult Only for acceptable taste or easy-to-mask active pharmaceutical ingredients Volumes >5 ml problematic for children <5 years Problems measuring Only low doses Alcohol, sugar content Emulsions Younger age group (unable to ...
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