This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity.
|Articles|October 2, 2003
- Pharmaceutical Technology-10-02-2003
- Volume 27
- Issue 10
Reducing the Time to Develop and Manufacture Formulations for First Oral Dose in Humans
Author(s)Loksidh D. Ganorkar, PhD
The authors discuss approaches to delivering formulations fo first-time-in-human dosing.
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Filling the Void: PAT in a Connected Manufacturing Environmentalmost 23 years ago
Process Analytical Technology Concepts and Principlesalmost 23 years ago
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The recently opened NJ spray drying facility doubles capacity for amorphous solid dispersions, addressing solubility limits in roughly 70% of small-molecule pipelines.
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