Manish Baviskar, Hubot CDMO, explains which AI skills validation engineers need first and why AI model updates must go through GMP change control.
|Articles|March 2, 2018
- Pharmaceutical Technology-03-02-2018
- Volume 42
- Issue 3
Pharmaceutical Technology, March 2018 Issue (PDF)
Click the title above to open the Pharmaceutical Technology March 2018 issue in an interactive PDF format.
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Articles in this issue
over 8 years ago
AR/VR Simulator for Plant Personnel Trainingover 8 years ago
Five-Hundred-Gallon Multi-Shaft Mixerover 8 years ago
Tackling Medicine Shortages in Europeover 8 years ago
A New Method for Risk Assessment of Pharmaceutical Excipientsover 8 years ago
FDA Heightens Drive for Transparencyover 8 years ago
Current Challenges in Bioprocesses Developmentover 8 years ago
Dissolved Oxygen Sensorover 8 years ago
Twin Screw Extruder Systemover 8 years ago
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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FDA draft guidance on individualized genome editing lets BLAs add patient-specific variants without new trials, shifting evidence to CMC assay data.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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