Ingredients
Formulation Development Forum: Nanosized Dendrimers
January 02, 2012
Nanosized systems are important in drug delivery. Such nanosized systems include liposomes, nanocrystals, micelles, colloidal particles, quantum dots, and dendrimers. Dendrimers are class of synthetic macromolecules with highly branched, monodispersed, circular, and symmetrical architecture that are used as carrier molecules in drug delivery.
FDA Perspectives: Designation of Regulatory Starting Materials in the Manufacturing of Drug Substances: Impact on ANDA Review Time
January 02, 2012
The author describes how providing appropriate information about the API in the Common Technical Document can aid FDA's review of an abbreviated new drug application.
Contract API Manufacturing: The Year in Review
December 02, 2011
Expansion activity was limited as fine-chemical producers and CMOs of API and intermediates grapple with changing industry fundamentals.
PQRI Case Study (7): PackOut Remedies to Minimize Contamination and Exposure
December 02, 2011
The seventh in a series of eight case studies from the Product Quality Research Institute focuses on packout remedies.
Views from Pharma Leaders: A Year in Review and a Look Forward
December 02, 2011
Drug shortages, supply-chain security, generic-drug incursion, and flexible manufacturing models are some of the issues shaping the bio/pharma industry.
The Development of a Floating Drug-Delivery System for Metronidazole
December 02, 2011
The authors developed a metronidazole-based floating drug-delivery system to investigate the effect of rate-controlling polymers on release pattern and duration of buoyancy in matrix tablets.
The Employment Outlook Brightens
December 02, 2011
Readers react to the economic turmoil of the past year and look longingly forward to 2012.
PQRI Case Study (8): Internal GMP Audit Program
December 02, 2011
The last in a series of eight case studies from the Product Quality Research Institute focuses on internal GMP audits.
PQRI Case Study (6): Packaging Line GMP Optimization
December 02, 2011
The sixth in a series of eight case studies from the Product Quality Research Institute focuses on packaging line GMP optimization.
Catalyzing the Synthesis
November 02, 2011
Researchers develop various catalytic approaches for improving yield, purity, stereoselectivity, and process conditions.