. "9788090473188" . . "4"^^ . . . "Ko\u010Da, Jaroslav" . . . . . . "Facta Medica" . "RIV/00216224:14110/14:00080095!RIV15-MSM-14110___" . "229"^^ . "Pecen, Ladislav" . . "Brno" . "Sou\u010Dkov\u00E1, Lenka" . . "\u0160im\u00ED\u010Dek, Martin" . "Klinick\u00E9 studie v praxi" . "Sou\u010Dkov\u00E1, Irena" . . "Klinick\u00E9 studie v praxi" . "Clinical research is necessary to establish the safety and effectiveness of specific health and medical products and practices. Much of what is known today about the safety and efficacy of specific products and treatments has come from randomized controlled clinical trials that are designed to answer important scientific and health care questions. Randomized controlled trials can be relied upon only if it is conducted according to principles and standards collectively referred to as \u201CGood Clinical Research Practice\u201D (GCP).This book is based on major international guidelines, including GCP guidelines, and could help with preparing, conducting and evaluation of clinical trials, describing the clinical research process as it relates to health and medical products."@en . . "Clinical Trial design; Phase I-III; biostatics; data management; monitoring; pharmacovigilance; study coordination"@en . "229"^^ . . "Klinick\u00E9 studie v praxi"@cs . "\u0160t\u011Bp\u00E1nov\u00E1, Radka" . "24327" . "Demlov\u00E1, Regina" . "V\u00FDznam klinick\u00FDch studi\u00ED pro rozvoj medic\u00EDny a v\u00FDvoj l\u00E9\u010Div je zcela z\u00E1sadn\u00ED, zejm\u00E9na vzhledem ke zji\u0161t\u011Bn\u00ED bezpe\u010Dnosti a \u00FA\u010Dinnosti l\u00E9\u010Div\u00FDch p\u0159\u00EDpravk\u016F i zdravotnick\u00FDch prodst\u0159edk\u016F a postup\u016F. V\u011Bt\u0161ina informac\u00ED, kter\u00E9 jsou zn\u00E1my o bezpe\u010Dnosti a \u00FA\u010Dinnosti konkr\u00E9tn\u00EDch l\u00E9\u010Div\u00FDch p\u0159\u00EDpravk\u016F, poch\u00E1z\u00ED z dat z\u00EDskan\u00FDch z kontrolovan\u00FDch klinick\u00FDch studi\u00ED, kter\u00E9 jsou navr\u017Eeny tak, aby byly schopny odpov\u011Bd\u011Bt na v\u00FDznamn\u00E9 v\u011Bdeck\u00E9 a zdravotn\u00ED ot\u00E1zky. Randomizovan\u00E9 kontrolovan\u00E9 studie mus\u00ED b\u00FDt v praxi prov\u00E1d\u011Bny dle z\u00E1sad a v souladu s principy a normami souhrnn\u011B ozna\u010Dov\u00E1ny jako %22spr\u00E1vn\u00E1 klinick\u00E1 praxe%22 (GCP). Tato kniha z t\u011Bchto pravidel vych\u00E1z\u00ED a sna\u017E\u00ED se p\u0159ibl\u00ED\u017Eit \u010Dten\u00E1\u0159i z\u00E1kladn\u00ED pravidla a principy p\u0159i p\u0159\u00EDprav\u011B, veden\u00ED a hodnocen\u00ED klinick\u00FDch studi\u00ED v praxi."@cs . . "Han\u00E1kov\u00E1, Michaela" . "Neuveden" . "Klinick\u00E9 studie v praxi" . "I" . "Kostkov\u00E1, Hana" . "14110" . "Klinick\u00E9 studie v praxi"@cs . . "V\u00FDznam klinick\u00FDch studi\u00ED pro rozvoj medic\u00EDny a v\u00FDvoj l\u00E9\u010Div je zcela z\u00E1sadn\u00ED, zejm\u00E9na vzhledem ke zji\u0161t\u011Bn\u00ED bezpe\u010Dnosti a \u00FA\u010Dinnosti l\u00E9\u010Div\u00FDch p\u0159\u00EDpravk\u016F i zdravotnick\u00FDch prodst\u0159edk\u016F a postup\u016F. V\u011Bt\u0161ina informac\u00ED, kter\u00E9 jsou zn\u00E1my o bezpe\u010Dnosti a \u00FA\u010Dinnosti konkr\u00E9tn\u00EDch l\u00E9\u010Div\u00FDch p\u0159\u00EDpravk\u016F, poch\u00E1z\u00ED z dat z\u00EDskan\u00FDch z kontrolovan\u00FDch klinick\u00FDch studi\u00ED, kter\u00E9 jsou navr\u017Eeny tak, aby byly schopny odpov\u011Bd\u011Bt na v\u00FDznamn\u00E9 v\u011Bdeck\u00E9 a zdravotn\u00ED ot\u00E1zky. Randomizovan\u00E9 kontrolovan\u00E9 studie mus\u00ED b\u00FDt v praxi prov\u00E1d\u011Bny dle z\u00E1sad a v souladu s principy a normami souhrnn\u011B ozna\u010Dov\u00E1ny jako %22spr\u00E1vn\u00E1 klinick\u00E1 praxe%22 (GCP). Tato kniha z t\u011Bchto pravidel vych\u00E1z\u00ED a sna\u017E\u00ED se p\u0159ibl\u00ED\u017Eit \u010Dten\u00E1\u0159i z\u00E1kladn\u00ED pravidla a principy p\u0159i p\u0159\u00EDprav\u011B, veden\u00ED a hodnocen\u00ED klinick\u00FDch studi\u00ED v praxi." . . "Svobodn\u00EDk, Adam" . . . "12"^^ . "Kadlecov\u00E1, Pavla" . "Machulka, Tom\u00E1\u0161" . "Clinical Trials in Practice"@en . "Clinical Trials in Practice"@en . "[55F2A55A7CF5]" . . "RIV/00216224:14110/14:00080095" . .