Guideline on quality of oral modified release products

Guideline on quality of oral modified release products

Overview of oral modified-release opioid products for the management of chronic pain.

OBJECTIVE To evaluate pharmaceutical and pharmacotherapeutic differences in oral opioid modified-release products used in the management of chronic pain. DATA SOURCES Searches of MEDLINE (1966-May 2006) and an extensive review of peer reviewed journals were conducted using the key search terms opioid, morphine, hydromorphone, and oxycodone. Supplemental information was gathered through the Am...

Workshop Summary: AAPS Workshop on Special Dosage Forms—What’s New with In Vitro Drug Release?

International Perspectives on the Drug Release of Special Dosage Forms This workshop was co-sponsored by FDA and FIP. This kick-off presentation introduced the workshop by providing background and objectives. The workshop focused on modified-release drug forms and included regulatory perspectives and specific presentations for orally disintegrating tablets, chewable oral drug products, ophthalm...

The revised EMA guideline for the investigation of bioequivalence for immediate release oral formulations with systemic action.

On August 1, 2010, a revised guidance regarding bioequivalence (BE) assessment for the approval of innovator (bridging studies, variations, line extensions) and generic medicinal products in the EU came into effect (EMA Guideline on the Investigation of Bioequivalence, CPMP/EWP/QWP/1401/98 Rev. 1/Corr**, London, 20 January 2010). This guideline specifies the requirements for BE assessment for i...

Factors to consider in developing individual pharmaceutical product quality risk profiles useful to government procurement agencies

Governments that procure pharmaceutical products from an Essential Medicine List (EML) bear special responsibility for the quality of these products. In this article we examine the possibility of developing a pharmaceutical product quality risk assessment scheme for use by government procurement officials. We use the Chinese EML as a basis, and US recall data is examined as it is publically ava...