UNASSIGNED: The advance of perinatal medicine has improved the survival of extremely premature babies, thereby creating a new and heterogeneous @entity1 group with limited information on appropriate treatment regimens. The developing fetus and neonate have traditionally been ignored populations with regard to safety studies of drugs, making medication during pregnancy and of newborns a significant safety concern. Recent initiatives of the FDA and @entity10208 have been passed with the objective of expanding the safe pharmacological treatment options in these @entity1 . There is a consensus that neonates should be included in clinical trials. Prior to these trials, drug leads are tested in @entity137 and pharmacology studies as governed by several guidelines summarized in the multidisciplinary ICH M3 (R2). Pharmacology studies must be performed in the major organ systems: cardiovascular, the respiratory and the CNS. The @entity1573 embryo and fetus have features that make it a convenient animal model for non-clinical safety studies where effects on all these organ systems can be tested. The developing @entity1573 is inexpensive, accessible and nutritionally self-sufficient with a short incubation time and is ideal for drug screening purposes. Other high throughput models have been implemented. However, many of these have limitations, including difficulty in mimicking natural tissue architecture and function ( @entity1 stem cells) and obvious differences from mammals in the respiratory organ system and certain aspects of CNS development ( @entity2199 , @entity3392 ).This minireview outlines the potential and limitations of the developing @entity1573 as an additional model for the early exploratory phase of development of new pharmaceuticals.

Cracking the egg: Potential of the developing XXXX as a model system for non-clinical safety studies of pharmaceuticals.

@entity1 :: ('9606', 'Species') :: ['human', 'patients', 'patient'] @entity2199 :: ('6239', 'Species') :: ['C. elegans'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity'] @entity1573 :: ('9031', 'Species') :: ['chicken'] @entity10208 :: ('MESH:D054069', 'Disease') :: ['EMA'] @entity3392 :: ('7955', 'Species') :: ['zebrafish']
@entity1573 :: (9031,Species) :: ['chicken']
