Ethical, legal, and social implications (ELSI) of microdose clinical trials.
Adv Drug Deliv Rev
; 63(7): 503-10, 2011 Jun 19.
Article
en En
| MEDLINE
| ID: mdl-21251940
ABSTRACT
A "microdose clinical trial" (microdosing) is one kind of early phase exploratory clinical trial, administering the compound at doses estimated to have no pharmacological or toxicological effects, aimed at screening candidates for further clinical development. This article's objective is to clarify the ethical, legal, and social implications (ELSI) of such an exploratory minimum-risk human trial. The definition and non-clinical study requirements for microdosing have been harmonized among the European Union (EU), United States (US), and Japan. Being conducted according to these regulations, microdosing seems to be ethically well justified in terms of respect for persons, beneficence, justice, human dignity, and animal welfare. Three big projects have been demonstrating the predictability of therapeutic dose pharmacokinetics from microdosing. The article offers suggestions as how microdosing can become a more useful and socially accepted strategy.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Diseño de Fármacos
/
Drogas en Investigación
/
Ensayos Clínicos Fase I como Asunto
Tipo de estudio:
Prognostic_studies
Aspecto:
Ethics
Límite:
Animals
/
Humans
País/Región como asunto:
America do norte
/
Asia
Idioma:
En
Revista:
Adv Drug Deliv Rev
Asunto de la revista:
FARMACOLOGIA
/
TERAPIA POR MEDICAMENTOS
Año:
2011
Tipo del documento:
Article