James E Akers

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OBJECTIVES To determine the clinical effectiveness, safety and cost-effectiveness of continuous positive airway pressure (CPAP) devices for the treatment of obstructive apnoea-hypopnoea syndrome (OSAHS), compared with the best supportive care, placebo and dental devices. DATA SOURCES The main search was of fifteen electronic databases, including MEDLINE,(More)
Variations in biological indicator (BI) lethality have been reported for several types of commercial BIs. This phenomenon has been observed among different lots of the same species and strain BIs from a single vendor. It has also been reported among BIs from different vendors but of the same species and strain that are intended to challenge the same general(More)
This article reviews current industry practices and regulatory expectations for the aseptic processing of sterile drugs. It provides comparisons and outlines points of tension between curent manufacturing technology and capabilities with regulatory “requirements” for this important activity. n 1988, the Parenteral Drug Association (PDA) published a position(More)
The use of isolator systems for sterility testing is on the increase. Prior to installation and validation careful consideration must be given to the type of barrier to be used, and the design of the facility which will house the barrier system. The validation of these systems requires development and testing of the sterilization cycle. Vapor phase hydrogen(More)
www.pharmtech.com art I of this article, published in the October 2001 issue of Pharmaceutical Technology, discussed the several causes of imprecisions in bubble-point determinations (1). The authors stated that a more accurate fix on the bubble point could be attained by implementing it with diffusive-airflow data. Such measurements, in conjunction with(More)