The enhanced pre- and postnatal development study for monoclonal antibodies.
Methods Mol Biol
; 947: 185-200, 2013.
Article
en En
| MEDLINE
| ID: mdl-23138905
The enhanced pre- and postnatal (ePPND) study design has been developed in response to new scientific knowledge and subsequent guideline changes [ICH M3(R2) and ICH S6(R1)]. The changes in study design were basically driven by the experiences obtained during preclinical development of biopharmaceuticals. The standard ePPND concept does not apply to conventional small molecule pharmaceuticals. In essence, the ePPND design is a pre- and postnatal development (PPND) study in which key elements of an embryo-fetal development study are investigated in newborns and infants rather than in the fetus. The cynomolgus monkey is the current relevant nonhuman primate model. The ICH S6(R1) guideline reached step 5 in June 2011 and provides detailed recommendations on various parameters and the conduct of an ePPND study. This chapter provides working guidance for monitoring menstrual cycles to generate pregnant animals, ultrasound monitoring of pregnancy, morphometric measurements of fetuses and newborns, in vivo skeletal examination, various protocols for evaluation of infants (e.g., neurobehavioral assessment, learning and memory test, grip strength, immune system evaluation) and a comprehensive list of additional infant evaluation parameters for the cynomolgus monkey.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Pruebas de Toxicidad
/
Teratología
/
Desarrollo Embrionario
/
Anticuerpos Monoclonales
Tipo de estudio:
Diagnostic_studies
Límite:
Animals
/
Pregnancy
Idioma:
En
Revista:
Methods Mol Biol
Asunto de la revista:
BIOLOGIA MOLECULAR
Año:
2013
Tipo del documento:
Article
País de afiliación:
Alemania
Pais de publicación:
Estados Unidos