In recent years, as more and more innovative drug products are going off patents, the search for new medicines such as botanical drug products that can treat critical and/or life-threatening diseases has become the center of attention of many pharmaceutical companies and research organizations such as the United States National Institutes of Health (NIH). A botanical drug product is often recog...

To the Editor: The dearth of information on drugs for children led to children being called “therapeutic orphans.” In 1975, Wilson determined that 78% of drug labeling had inadequate pediatric information. In 1999, Wilson summarized 25 years of efforts to get pediatric information into labeling and extended his analysis. In the decade after Wilson’s review, regulations and legislation have led ...

In 2006, the Product Quality Research Institute’s (PQRI) Leachables and Extractables Working Group released a comprehensive and detailed recommendation document related to leachables and extractables for inhalation drug products. The document includes best pharmaceutical development practice recommendations regarding container closure/delivery system component composition and selection, control...