Translatability scoring in drug development: eight case studies

Impact of drug transporter studies on drug discovery and development.

Drug transporters are expressed in many tissues such as the intestine, liver, kidney, and brain, and play key roles in drug absorption, distribution, and excretion. The information on the functional characteristics of drug transporters provides important information to allow improvements in drug delivery or drug design by targeting specific transporter proteins. In this article we summarize the...

Leveraging exploratory investigational new drug studies to accelerate drug development.

In 2006, the U.S. Food and Drug Administration published its guide on exploratory investigational new drug (IND) studies with the goal of making the approach to early-stage, pilot clinical trials more flexible within the context of current regulations. The exploratory IND allows sponsors to initiate clinical trials of limited scale with reduced preclinical requirements. These studies may be imp...

Case Studies of Community Anti - Drug Efforts

In response to the illicit drug trade that became especially troublesome in the late 1980's and early 1990's, a remarkable community anti-drug movement has formed, with groups becoming active in some of the most afflicted neighborhoods. Armed only with their courage and imagination, citizens have devised a variety of clever strategies and tactics to reclaim their streets and parks from drug tra...

Preadolescent development: case studies in twins.

The authors studied eight sets of healthy twins, ranging in physical maturity from prepubertal to late pubertal, and their parents, to assess psychological changes in early adolescence. A phase-specific psychosocial regression correlates with the biological onset of puberty. We present preliminary findings related to twinship, parental reactions, and longitudinal development, based on detailed ...

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