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Qualification of a Swab Sampling Procedure for Cleaning ValidationThe authors present a simple way to qualify a swab-sampling procedure for its ability to recover residues of a small-molecule API from cleaned equipment surfaces.
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Qualification of a Swab Sampling Procedure for Cleaning ValidationThe authors present a simple way to qualify a swab-sampling procedure for its ability to recover residues of a small-molecule API from cleaned equipment surfaces.
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Combination of Regulatory Incentives and Patient Advocacy Drive Rare-Disease Drug Development (Part 2)Dan Williams, CEO of SynaptixBio discusses drivers of rare disease drug development, including FDA incentives, priority review vouchers, and a growing recognition of unmet needs.
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A Novel Method for Host Cell Protein AnalysisThis method is expected to help bring gene therapies to market faster, safer, and cheaper.
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Drug Digest: Emerging Therapies In all Shapes and SizesThursday April 28, 2022 at 11am ET | 10am CT | 8am PT In this new video series, Drug Digest, the Pharmaceutical Technology editors examine the topic of emerging therapies in more detail, covering subjects such as the challenges of scale, the potential benefits of drug delivery innovation, importance of early analytical studies, the evolution of the regulatory landscape, and differences between regional regulatory requirements. Join the editors as they speak with experts from Regulatory Compliance Associates (RCA), the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), and others.
