The agreement between CDER and OII with allow for coordinated marketing application assessments and inspections.
|Articles|September 2, 2012
- Pharmaceutical Technology-09-02-2012
- Volume 36
- Issue 9
Pharmaceutical Technology, September 2012 Issue (PDF)
Process Analytical Technology
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Articles in this issue
about 14 years ago
Formulation Development Forum: Hydrogels for Long-Sustained Releaseabout 14 years ago
Regulation and Complianceabout 14 years ago
2,4,6-Tribromoanisole and 2,4,6-Trichloroanisoleabout 14 years ago
Early Development GMPs for Stability (Part IV)about 14 years ago
Joint Regulatory Conferences: The Ultimate Connectionabout 14 years ago
Future Innovation in Drug Deliveryabout 14 years ago
Temperature-Controlled Shippersabout 14 years ago
Technology Transfer: Protecting the True Public Interestabout 14 years ago
Europe Hones in on Antitrust Violationsabout 14 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FDA draft guidance on individualized genome editing lets BLAs add patient-specific variants without new trials, shifting evidence to CMC assay data.
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