The authors evaluate the implications of product photosensitivity and how it influences various aspects of product development. They discuss a product photosensitivity classification system and present a photosensitive pharmaceutical product case study. hotostability testing in the pharmaceutical industry has evolved rapidly, particularly since the May 1997 publication of the ICH Q1B guidance “...

Control of elemental impurities in pharmaceutical materials is currently undergoing a transition from control based on concentrations in components of drug products to control based on permitted daily exposures in drug products. Within the pharmaceutical community, there is uncertainty regarding the impact of these changes on manufactures of drug products. This uncertainty is fueled in part by ...

a 51 hour (3 credit) lecture course entitled pharmaceutical biotechnology is outlined which details the biochemistry and biotechnology of biological drug products. it is designed to equip students undertaking pharmacy program with an understanding of concepts, both academic and applied, directly relevant to working in the biotechnological products sector. in addition to the course, a bank of re...

Thimerosal (Merthiolate) is an ethylmercury-containing pharmaceutical compound that is 49.55% mercury and that was developed in 1927. Thimerosal has been marketed as an antimicrobial agent in a range of products, including topical antiseptic solutions and antiseptic ointments for treating cuts, nasal sprays, eye solutions, vaginal spermicides, diaper rash treatments, and perhaps most importantl...

The current practice of characterization and control of impurities in pharmaceutical substances and products are reviewed with emphasis on issues specific to the active pharmaceutical ingredient and pharmaceutical formulations. The control of pharmaceutical impurities in the pharmaceutical industry is an important task to the formulator. The International Conference on Harmonization (ICH) has f...

The chairs of each of the 8 Special Interest Groups of the Board of Pharmaceutical Sciences of the International Pharmaceutical Federation have compiled opinions with regard to major challenges for the pharmaceutical sciences over the next 5-10 years. Areas covered are drug design and discovery, natural products, formulation design and pharmaceutical technology, pharmacokinetics/pharmacodynamic...