Pharmacists and Regulatory Science

Advancing regulatory science, advancing regulatory practice

In an Editorial of Science in 2011, Margaret A. Hamburg, the then Commissioner of the US Food and Drug Administration highlighted that a strong field of regulatory science is required to develop new tools, standards and approaches that efficiently and consistently assess the safety, efficacy and performance of products, and that this field has long been underappreciated and underfunded.1 During...

Boundaries of Regulatory Science

Hormesis in Regulatory risk assessment - Science and Science Policy.

This brief commentary will argue that whether hormesis is considered in regulatory risk assessment is a matter less of science than of science policy. I will first discuss the distinction between science and science policy and their roles in regulatory risk assessment. Then I will focus on factors that influence science policy, especially as it relates to the conduct of risk assessments to info...

From Science and Engineering to Regulatory Requirements

systems play an essential role in today’s biopharmaceutical processes. Recombinant E. coli and yeast systems are dominant tools in early discovery of effective medical targets. These systems are also routinely used to produce biological reagents for analytical methods in research and quality controls of products. In the biopharmaceutical industry, microbial systems have delivered major medicine...

Science and technology of the emerging nanomedicines in cancer therapy: A primer for physicians and pharmacists

Nanomedicine, the medical applications of devices based on nanotechnology, promises an endless range of applications from biomedical imaging to drug and gene delivery. The size range of the nanomaterials is strictly defined as 1-100 nm, although many marketed nanomedicines are in the submicron range of 100-1000 nm. The major advantages of using nanomaterials as a carrier for anticancer agents a...