Analytical difficulties facing today's regulatory laboratories: issues in method validation

Air toxics regulatory issues facing urban settings.

Biomarker research does not exist in isolation. Its usefulness can only be realized when it is translated into prevention strategies to protect public health. In the context of air toxics, these prevention strategies begin with the development of regulatory standards derived from risk assessment schemes. The Clean Air Act Amendments of 1990 list 189 air toxics, including many volatile organics,...

Analytical Method Validation

In pharmaceutical industries, the validation of analytical methods is used to demonstrate that the method is fitted for its purpose; it must follow a plan which includes scope, performance characteristics, and acceptance limits. Analytical methods need to be validated or revalidated prior to their introduction into routine analyses (release of batch). The overarching philosophy in current good ...

Analytical Method Validation for Biopharmaceuticals

Difficulties facing physician mothers in Japan.

Despite recent increases in the number of female physicians graduating in Japan, their premature resignations after childbirth are contributing to the acute shortage of physicians. Previous Japanese studies have explored supportive measures in the workplace, but have rarely focused on the specific problems or concerns of physician-mothers. Therefore, this study explored the challenges facing Ja...

Information system issues facing clinical laboratories serving complex integrated delivery systems.

Laboratory information systems (LISs) have evolved into complex applications to meet the specialized needs of laboratories. As integrated delivery systems (IDSs) continue to emerge as a dominant model for healthcare delivery, clinical laboratories serving them face two imperatives that affect IS decisions. First, laboratories in IDSs must consolidate to reduce costs and duplication yet deliver ...