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. The importance of TARGET PRODUCT PROFILES resides in their role in identifying the critical attributes of Some organizations, such as WHO, UNICEF and a PRODUCT before development begins, to ensure the Drugs for Neglected Diseases initiative, have that the final PRODUCT is adapted and responds developed TARGET PRODUCT PROFILES for specific to the needs of the end-users (Fig.)

fixed-dose combinations Weight based dosing Possible to administer the same dosage form across multiple weight bands 1 formulation for children age <6 years; 1 formulation for age >6 years: adult (or half a dose) Possible to administer the same dosage form across multiple weight bands Administration considerations

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  Dose, Combination, Fixed, Dose combination

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