title: [Animal toxicology studies necessary for clinical research and the registry of drugs for human use: conclusions of the International Conference of Harmonization (and II)].
authors.affiliation: Subdirección General de Evaluación de Medicamentos, Ministerio de Sanidad y Consumo, Madrid.
authors.forename: C
authors.initials: C
authors.lastname: Tristán
authors.forename: I
authors.initials: I
authors.lastname: Galende
authors.forename: C
authors.initials: C
authors.lastname: Rubio Terrés
authors.forename: I
authors.initials: I
authors.lastname: Duque
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy; D000465:Algorithms; D000826:Animal Testing Alternatives; D000818:Animals; D001709:Biotechnology; D002986:Clinical Trials as Topic / Q000379:methods / Q000592:standards; D004353:Drug Evaluation, Preclinical / Q000379:methods* / Q000592:standards* / Q000706:statistics & numerical data; D006801:Humans; D007231:Infant, Newborn; D014116:Toxicology / Q000592:standards*
vernacular_title: Estudios de toxicología animal necesarios para la investigación clínica y el registro de medicamentos de uso en humanos: conclusiones de la Conferencia Internacional de Armonización (y II).