Drug safety in Australia is regulated via the Office of Medicines Safety Monitoring (OMSM) (synonymous with Adverse Drug Reaction Advisory Committee), a branch of the Therapeutic Goods Administration (TGA). In New Zealand, Medsafe is the regulatory ...
Drug supply chain is very costly and is a well-recognized bottleneck at the design and managing of clinical trials. The innovative risk-based statistical approach to modelling drug supply demand for a single study is proposed. The approach uses the ...
Tuesday, September 01, 2009
Major pharmaceutical and emerging biopharmaceutical companieshave a plethora of choices in utilizing contract-manufacturingorganizations (CMOs) available in the global market place for their custom synthesis needs. However, establishing a ...
Wednesday, September 01, 2010
The research-based pharmaceutical industry has always accommodated change, and like other businesses, is increasingly becoming cost constrained due in part to the rising investment required to develop new medicines and the global economic environment...
Wednesday, September 01, 2010
As the world economy and financial markets contracted in 2009, so
did the market for biopharmaceutical contract manufacturer services.
Monday, November 01, 2010
A screening compound collection is recognized as a valuable asset by most pharmaceutical companies and Compound Management is now a key component of the Drug Discovery process.
A number of trends can be identified in the delivery of parenteral
drugs in the last decade.
For a commercial technology transfer, the ultimate measure of success is regulatory approval of the transferred process at the new site.
The amount of time required to successfully develop a new drug candidate from discovery to commercialization is estimated to be 12-15 years and the associated cost to be approximately $1 Billion dollars [1].
Saturday, January 01, 2011
Temperature-sensitive medicinal products deliver unique value to
the end-user while introducing several logistical risks to the shipper.