Articles in this Issue
Mark Morton, Ph.D.
The use of near-infrared spectroscopy (NIRS) has been widely documented within pharmaceutical quality and manufacturing functions as a unit operation, but much less has been written about it when it ...
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Frederick H. Long, Ph.D.
Multivariate analysis (MVA) is the statistical analysis of many variables at once. Many problems in the pharmaceutical industry are multivariate in nature. The importance of MVA has been recognized by...
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Edmond Ekenlebie, Andrew Ingham
This review will highlight rational approaches and considerations for cost-efficient, short-cycle development with emphasis on bulk freeze drying. It must be noted that published work on ...
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Jingshun Sun
Water uptake by a drug substance is an inherent property but also subject to its surrounding environment. During pharmaceutical development, knowing the hygroscopic nature of a drug substance is ...
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Shannon Southall, Amol Ketkar, Charlene Brisbane, Doug Nesta, Ph.D.
The need to detect, monitor, and characterize particulates in parenteral products has become one of the most noteworthy trends in the biopharmaceutical industry. The level of aggregates and ...
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Ann Newman, Ph.D.
Solid form screening is commonly performed to find a candidate with optimal properties for early development or to find a form with different properties to improve a formulation in later development.
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Veeran G. Kadajji, Guru V. Betageri, Natarajan Venkatesan
Dissolution technique is an excellent tool for monitoring batch-to-batch quality control and to understand drug release in in-vivo conditions. Dissolution methods are mostly recommended for solid oral...
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Samuel Maldonado M.D., M.P.H., FAAP, Daniel Schaufelberger, Ph.D.
It has long been recognized that the therapeutic needs of children are sufficiently different than those of adults as to require specific studies of medications in children. Since most children are ...
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Kim Bowers, Lynn Tran
Abstract:
Detection of endotoxin that may be present in biopharmaceutical products is critical to patient safety. Although the endotoxin molecule itself is highly stable, various factors such as ...
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Vibeke Halkjaer-Knudsen
The fierce and aggressive competition for moving new pharmaceutical products quickly through development and registration to an effective market launch creates high demands for production efficiency, ...
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Michael Siedler, Ph.D.
Since the beginning of development of monoclonal antibodies (mAb) in the 1980s, they become vastly successful as efficacious and safe therapeutics for a variety of diseases. Today, they represent one ...
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Michael B. Hicks, Ph.D., Yingru Zhang, Ph.D., Douglas Moore, Atsu Apedo
Supercritical Fluid Chromatography (SFC) expedites both chiral and achiral
separations by enabling analysts to resolve the more challenging sample
mixtures rapidly with less solvent usage than with ...
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Catherine Sheehan, Gregory E. Amidon
An excipient’s functional category is a qualitative classification or term that describes the purpose or role of an excipient in a drug product. However, the current regulatory environment and the ...
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