The process of integrating these 23 US generic drug products
is well underway with the successful manufacture of engineering batches of 1mg and 8mg Doxazosin Mesylate tablets in IDT's Boronia manufacturing facility.
Analyzes design factors, material selection issues, technologies and market development issues for injection devices, inhalation devices and transdermal drug products
designed for self-administration
The FDA s recent inspection of the Downing Labs facility revealed sterility failures in 19 lots of drug products
intended to be sterile, endotoxin failures in three lots of drug products
, and inadequate or no investigation of these failures.
Contamination of the drug product
is dependant on the transport properties of the migrating substance in relation to the package, product and environment.
A formulation method to improve the physical stability of macromolecular-based drug products
Two recent inspections of the Unique Pharmaceuticals facility conducted by the FDA revealed insanitary conditions that result in a lack of sterility assurance of drug products
produced at that facility.
The National Drug Code Directory relies primarily on drug listing information to provide details on marketed drug products
The guidance focuses on CGMP requirements related to sterility assurance of sterile drug products
and the general safety of compounded drug products
He is also co-editor of Informa Healthcare's Generic Drug Product
Development: Bioequivalence Issues, Generic Drug Product
Development: International Regulatory Requirements for Bioequivalence, and Generic Drug Product
Development: Specialty Drug Products
Oxygen Absorbing Canisters were not the cause nor were involved with this drug product
Highlights -- Provides detailed analysis of drug self-administration market segments, market dynamics and market demographics -- Analyzes therapeutic demand drivers and evaluates commercial drug products
in more than two dozen major self-administration therapeutic segments -- Analyzes design factors, material selection issues, technologies and market development issues for injection devices, inhalation devices and transdermal drug products
designed for self-administration -- Charts product data, market share, and forecasts to 2018 -- Profiles self-administration drug product
and device participants, their product development activities, business strategies, and corporate alliances and affiliations
market size for the drug product
is approximately $200 million.