Manish Baviskar, Hubot CDMO, explains which AI skills validation engineers need first and why AI model updates must go through GMP change control.
|Articles|August 1, 2010
- Pharmaceutical Technology-08-02-2010
- Volume 34
- Issue 8
Pharmaceutical Technology, August 2010 Issue (PDF)
Big Pharma?s Manufacturing Strategy: What is the Next Move?
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Articles in this issue
about 16 years ago
A Commendable Cleanroom Compendiumabout 16 years ago
Adopting Serializationabout 16 years ago
Manufacturing Failures Place GMP Compliance in Spotlightabout 16 years ago
An Ounce of Preventionabout 16 years ago
Statistical Considerations in Design Space Development (Part II of III)about 16 years ago
Turning a Blind Eyeabout 16 years ago
Report from Asiaabout 16 years ago
Q&A with Jerry JostAdvertisement
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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FDA draft guidance on individualized genome editing lets BLAs add patient-specific variants without new trials, shifting evidence to CMC assay data.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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