| PEER-REVIEWED RESEARCH |
Ad Gerich, Michiel Damen, Willy Verhoeven, Jorina Verhoog, Sai Prasanth Chamarthy, Rut Besseling
This study shows that the presence of API lumps can be detected by inline NIR, and elaborates on why NIR sensor dimensions and actual measured sample volume by the NIR sensor are important variables for adequate interpretation of obtained results.
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| API SYNTHESIS AND MANUFACTURING |
Cynthia A. Challener
Drug repurposing, repositioning, and rescue can be faster, cheaper, and target more diseases than traditional drug discovery approaches.
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| FORMULATION |
Matthew T. Marmura and Poonam Sheth
Considerations in selecting a dosage form for drug delivery to the lungs.
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| SCALE-UP |
Jennifer Markarian
Continuous twin-screw granulation offers several options for increasing production scale. Thermo Fisher Scientific explains factors to consider in scale-up projects for manufacturing oral solid-dosage drugs.
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| ANALYTICS |
Hildegard Bruemmer and Natalia Belikova
Forced degradation studies can identify stability problems for drug substance and drug products.
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| QUALITY BY DESIGN |
Frances DeGrazio
When it comes to getting the best out of quality by design, timing is everything.
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| FACILITY DESIGN AND OPERATIONS |
John Robinson, Spencer Miller, Laurence T. Baxter, Stephen Hunt, Bob Todd, and Joseph F. Pekny
Modeling tools help process engineers optimize a biopharmaceutical facility's capacity.
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| REGULATORY WATCH |
Jill Wechsler
FDA works with industry on strategies for assuring high-quality regenerative medicines.
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Sean Milmo
EMA recognizes that a regulatory framework, under which medicines and diagnostics are developed and approved independently, may not be ideal.
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| OUTSOURCING OUTLOOK |
Eric Langer and Ronald A. Rader
Innovation speeds discovery, drives down costs, and improves productivity.
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| ASK THE EXPERT |
Siegfried Schmitt
The differences between the quality control and quality assurance units can be found in their names, according to Siegfried Schmitt, principal consultant at PAREXEL.
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| FROM THE EDITOR |
Rita C. Peters
Faced with divisive political and social issues, Congress must find a way to reach consensus.
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