Manish Baviskar, Hubot CDMO, explains which AI skills validation engineers need first and why AI model updates must go through GMP change control.
|Articles|October 2, 2001
- Pharmaceutical Technology-10-02-2001
- Volume 25
- Issue 10
System Optimization for In Situ Fiber-Optic Dissolution Testing: Hydrodynamic Effects, System Performance, and Applications
Testing of an in situ fiber-optic transmission probe demonstrates sound hydrodynamic performance and reduced stray-light limitations.
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Articles in this issue
about 25 years ago
Outsourcing Outlookabout 25 years ago
Hydrogels for the Controlled Release of Pharmaceutical Proteinsabout 25 years ago
Near-Infrared Inspection Complements Other QC Systemsabout 25 years ago
Safety and Manufacturing Standardsabout 25 years ago
Current Status of the Oral Delivery of Insulinabout 25 years ago
Laboratory Equipment Qualificationabout 25 years ago
Filter Integrity Testing in Liquid Applications, Revisited, Part IAdvertisement
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Ron Filler, Drug Development Consultants, explains how USP's 1074 revision brings human-relevant safety science to formulators and excipient makers.
Nitin Kumar Swarnakar, PhD, global application lab manager at BASF, talks about spray drying for drying amorphous solid dispersions and Raman spectroscopy’s role as a quantitative analytical tool.
Aleksandra Zuraw, senior veterinary pathologist at Charles River, discusses how chain of custody, good laboratory practice, quality control, and validation are applied to digital pathology data used in drug development.
Ron Filler, Drug Development Consultants, explains how USP's 1074 revision brings human-relevant safety science to formulators and excipient makers.
Nitin Kumar Swarnakar, PhD, global application lab manager at BASF in Tarrytown, spoke with PharmTech at AAPS PharmSci 360 about formulation and characterization challenges for amorphous solid dispersions.
FDA draft guidance on individualized genome editing lets BLAs add patient-specific variants without new trials, shifting evidence to CMC assay data.
Bill Williams, AAPS, compares KinetiSol and spray drying for amorphous solid dispersions, covering 75% drug loading, pill burden, weakly basic drug release, and process limits.
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