Felicity Thomas
Increasing prevalence of drug misuse and abuse is driving a heightened and more stringent approach to abuse-deterrent formulations.
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| MANUFACTURING |
Madison Hoal, Donald Singer
Consider how to assess risks and understand possible sources of disinfectant residues in pharmaceutical manufacturing.
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| PEER-REVIEWED RESEARCH |
Arvind Srivastava, Ger Brophy, Meera Agarkhed
The authors compare formulations containing citrate with other buffers in reducing subcutaneous injection-site pain and discuss a formulation and excipients selection strategy.
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| QUALITY/REGULATIONS |
Lauren Lavelle
The complexity of biologics and the use of new technologies present challenges for complying with CGMPs.
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| OPERATIONS |
Hallie Forcinio
Advances in intelligent technologies for pharmaceutical packaging improve online productivity, authenticate product, and boost patient adherence.
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Agnes Shanley
The COVID-19 pandemic has led to increased demand for direct-to-patient shipments, challenging cold-chain specialists to become more agile and to strengthen their global distribution networks.
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| OUTSOURCING |
Feliza Mirasol
Bioanalytical studies are an important aspect of biologic drug development that may necessitate partnering with bioanalysis experts.
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| FROM THE EDITOR |
Rita C. Peters
Achieving herd immunity will require testing, data, a vaccine, and public support.
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| US REGULATORY WATCH |
Jill Wechsler
FDA and the US Congress support innovation and access to cheaper medicines.
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| ASK THE EXPERT |
Susan J. Schniepp
Products must be manufactured in accordance with appropriate regulatory requirements, even during a pandemic, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
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