Bioanalytical method transfer considerations of chromatographic-based assays.

Bioanalysis is an important part of the modern drug development process. The business practice of outsourcing and transferring bioanalytical methods from laboratory to laboratory has increasingly become a crucial strategy for successful and efficient delivery of therapies to the market. This chapter discusses important considerations when transferring various types of chromatographic-based assays in today's pharmaceutical research and development environment.

Abbreviated assessment of bisphenol A toxicology literature.

Bisphenol A (BPA), synthesized in 1891, is produced in quantities of >2 million metric tons annually for polycarbonate plastics, epoxy resins and food contact applications. BPA can be a weak estrogen mimic, and is ubiquitous in humans (in 93% US population; in 96% US pregnant women). European/US food/drug agencies conclude that current BPA levels present no risk to the general population (some include infants/children); basic endocrine disruption (ED) researchers state that entire populations are at risk from these levels. The US Food and Drug Administration banned BPA in baby bottles in 2012 'not based on safety concerns'; the US Environmental Protection Agency and its UK counterpart concurred. Basic ED researchers report reproductive/developmental effects from perinatal BPA exposure in mice at very low doses, e.g. 2 ng/g body weight (0.002 mg/kg body weight), with non-monotonic dose-response (NMDR) curves, using few animals per group and few groups; contract research organizations, in good laboratory practice- and guideline-compliant large studies in rats and mice, report no low-dose effects or NMDR curves. The argument rages!