Ron Filler, Drug Development Consultants, explains how USP's 1074 revision brings human-relevant safety science to formulators and excipient makers.
|Articles|September 2, 2009
- Pharmaceutical Technology-09-02-2009
- Volume 33
- Issue 9
Pharmaceutical Technology, September 2009 Issue (PDF)
Robots Lend a Hand
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Articles in this issue
about 17 years ago
Pharma Capsulesabout 17 years ago
Of Audits and Gunkabout 17 years ago
Quality by Enforcementabout 17 years ago
Robots: The Next Phase in Pharmaceutical Automationabout 17 years ago
It's Easy Being Greenabout 17 years ago
Expansion Planabout 17 years ago
A Green Manufacturing Route to Testosteroneabout 17 years ago
In the Spotlight September 2009about 17 years ago
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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FDA draft guidance on individualized genome editing lets BLAs add patient-specific variants without new trials, shifting evidence to CMC assay data.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.
Vibha Jawa, PhD, chief scientific officer at EpiVax, discusses the limitations of current preclinical testing approaches and how new approach methodologies can strengthen drug development.
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