G.K. Shiu


Product quality, like safety and efficacy, is a prerequisite for manufacturing approval of all pharmaceutical products. This requirement must not be compromised even after the product has been approved for marketing. Development of in vitro testing methods that are predictive for product in vivo performance is the most challenging goal in product quality research. In recent years, our Laboratory has been involved in this area of research for a variety of pharmaceutical products including oral solid dosage forms, metered dose inhalers, suspension products, transdermal patches and topical products including creams, ointments, and suppositories. The author intends to share some of his research experience in addressing product quality issues for the above mentioned dosage forms in a series of review and research articles. As the first in this series, an overview of the quality issue for oral solid dosage forms is presented.