You searched for: optimized (Finska - Engelska)

selitys: 1gss obt:lle: genotypic sensitivity score optimoidulle muulle hiv-lääkitykselle (obt, optimized background).
key: 1gss to obt: genotypic sensitivity score to optimised background.

17alue kliininenkliininen kliininenkuvaus haitta-hyötyarvioinnin tueksi hakija sitoutuu lisäksi toimittamaan chmp: n tarkastettavaksi 48 viikon tehoa ja turvallisuutta koskevat tiedot vielä keskeneräisestä vaiheen iii tutkimuksesta 018 (a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and antiretroviral activity of mk-0518 in combination with an optimized background therapy (obt) , versus optimized background therapy alone, in hiv-infected patients with documented resistance to at least 1 drug in each of the 3 classes of licensed oral antiretroviral therapies) ja tutkimuksesta 019 (a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and antiretroviral activity of mk-0518 in combination with an optimized background therapy (obt) , versus optimized background therapy alone, in hiv-infected patients with documented resistance to at least 1 drug in each of the 3 classes of licensed oral antiretroviral therapies) .hakija sitoutuu toimittamaan chmp: lle yksityiskohtaiset spesifiset suunnitelmat resistenssitilanteen seuraamisesta tihein raportointivälein.
area clinicalclinical clinicaldescription to further support the benefit: risk assessment, the applicant commits to provide chmp with the 48-week safety and efficacy data from the ongoing phase iii protocol 018 (a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and antiretroviral activity of mk-0518 in combination with an optimized background therapy (obt) , versus optimized background therapy alone, in hiv-infected patients with documented resistance to at least 1 drug in each of the 3 classes of licensed oral antiretroviral therapies) and protocol 019 (a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and antiretroviral activity of mk-0518 in combination with an optimized background therapy (obt) , versus optimized background therapy alone, in hiv-infected patients with documented resistance to at least 1 drug in each of the 3 classes of licensed oral antiretroviral therapies) for review.the applicant commits to provide the chmp with detailed specific plans for monitoring of resistance with frequent reporting intervals.the applicant commits to provide the chmp with the full protocol for an observational post-authorisation safety study as specified in the rmp for assessment prior to study initiation.17due date study reports submission by:31-mar-200831-dec-2007