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Felicity Thomas
Reformulation strategies can provide drug developers with a head start to achieve promising options that benefit the patient.
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| MANUFACTURING |
Jennifer Markarian
Equipment and process optimization must be considered for scaling up these developmental technologies to commercial production.
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Aaron Mertens, Joe McCall
A well-defined contamination control program is essential to maintain quality through aseptic manufacture of parenteral drug products.
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| PEER-REVIEWED RESEARCH |
Lei Lei, Pramote Cholayudth
The CuDAL-Excel program, based on Microsoft (MS) Excel, has been developed to calculate the United States Pharmacopeia (USP) passing probability of content uniformity and dissolution tests for both sampling plan 1 and sampling plan 2 scenarios and for both immediate release and extended release requirements. The users can obtain the passing probability by simply entering the input variables, with wide applications for process validation/verification and batch release. As a user-friendly program, CuDAL Excel should bring more benefits to the industry practitioners than other existing programs/tools.
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| ANALYTICS |
Agnes Shanley
Discovery of carcinogenic nitrosamines in three of the world’s most widely prescribed drugs is driving efforts to better detect, control and prevent their generation in APIs and finished drug products.
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| OPERATIONS |
Brent Denton, John Bak, Jonathon Salsbury
Light obscuration testing is the preferred method of sub-visible particle quantification but is not suitable for every preparation.
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| OUTSOURCING |
Cynthia A. Challener
Experience, communication, collaboration, transparency, planning, and prioritization contribute to success.
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| FROM THE EDITOR |
Rita C. Peters
Will moving at “warp speed” to develop a vaccine impact efficacy or safety?
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| US REGULATORY WATCH |
Jill Wechsler
Policy makers seek to ensure supplies of new therapies and to limit shortages.
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| ASK THE EXPERT |
Siegfried Schmitt
Having a better understanding about compliance will be of benefit when looking for a job or for furthering one’s career, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.
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