Pharmacy Administration, Policy and Regulation Commons^™

Incentives For Orphan Drug Research And Development In The United States, Enrique Seoane-Vazquez, Rosa Rodriguez-Monguio, Sheryl L. Szeinbach, Jay Visaria

Pharmacy Faculty Articles and Research

Background: The Orphan Drug Act (1983) established several incentives to encourage the development of orphan drugs (ODs) to treat rare diseases and conditions. This study analyzed the characteristics of OD designations, approvals, sponsors, and evaluated the effective patent and market exclusivity life of orphan new molecular entities (NMEs) approved in the US between 1983 and 2007.

Methods: Primary data sources were the FDA Orange Book, the FDA Office of Orphan Drugs Development, and the US Patent and Trademark Office. Data included all orphan designations and approvals listed by the FDA and all NMEs approved by the FDA during …

Why Pharmacists Choose To Seek Or Not Seek Board Certification In Pharmacy Practice: A Comparison Of Motivation And Motivating Factors, Mark Tankersley

Theses and Dissertations (ETD)

The stated mission of the Board of Pharmaceutical Specialties (BPS) with regard to specialization is, via board certification, to recognize specialty areas, define skill standards for those specialty areas, and evaluate the knowledge and skills of individual Pharmacy specialists. The perceived or real benefits to the pharmacist of pursuing board certification are unknown. These benefits can be evaluated by separating into values (valences) and instrumentalities, the latter of which is the perceived or known probability that a performance will lead to an outcome. The primary purpose of this study was to determine the differences in values and instrumentalities perceived by …

Drug Selection And Adverse Drug Reactions: Balancing Outcomes And Costs, Enrique Seoane-Vazquez

Pharmacy Faculty Articles and Research

"Regulatory agencies approve drugs for marketing when the ratio of risk to benefit of the drugs is positive, i.e. the potential benefit of using the drug justifies the risk of drug related adverse reactions (ADR). At the point of approval of a drug there is not adequate information about all possible negative outcomes arising from its use in clinical practice. The information is even more limited for patient subgroups, diseases and treatment combinations that were not evaluated in the clinical trials required for approval. Therefore, performing post-marketing pharmacoepidemiological studies is necessary for a better understanding of drug use in usual …