Drug Validation

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• Drug Delivery: The "Great Equalizer"
  By Angelo De Palma, Ph.D., Contributing Editor FACED WITH HIGH COSTS, long development times, regulatory uncertainty and the need to differentiate products, pharmaceutical manufacturers are banking on drug delivery to deliver value. Drug delivery is the great equalizer, perhaps the only area...
• Drug Pedigree Standard Established
  chains, has announced the approval of the EPCglobal Electronic Pedigree Document specification. A drug pedigree is a record of each distribution of a prescription drug from its sale by a manufacturer through acquisition and sale by any wholesale distributor until final sale to a pharmacy or other...
• Drug Delivery: The "Great Equalizer"
  By Angelo De Palma, Ph.D., Contributing Editor Intranasal drug delivery is also coming of age. As of this writing, close to 20 Investigational New Drug (IND) applications were in the works for nasal analgesics, mostly established medications, according to BioPharm Insight. Nasal delivery offers...
• Drug Makers Fight Back!
  of snake oil salesmen: drug counterfeiters, who now command a global market worth up to $50 billion. Despite stringent cGMP regulations, criminal penalties set by the Prescription Drug Marketing Act (PDMA), and reporting requirements set by Sections 321 and 322 of the Bioterrorism Preparedness Act...
• Drug Makers Fight Back!
  This quick, one-time registration gives you access to members-only site benefits. As legislators move to allow U.S. consumers to buy lower-priced prescription medications from abroad, questioning the safety of the offshore drug supply has become extremely unpopular. "It's a politically charged...
• Drug Delivery: The "Great Equalizer"
  controlled-release, oral formulation for an existing drug in a few months and complete Phase I trials in about a year and a half, for approximately $1 million. Depomed says it can do all that while adding only about one cent (at the manufacturer level) to the cost of a dose. Approval takes two...
• Drug Makers Fight Back!
  Manufacturers take different approaches to selecting anti-counterfeiting technology, with some emphasizing detection and others deterrence, says Richard Jotcham, Director of Technology Services for of Axess Technologies Ltd. in the U.K, a partner in the Product Surety initiative. "Each drug needs...
• Drug Delivery and QbD: A Collision of Lifecycles
  guidance, but have made great strides in identifying a path forward within the product development and quality infrastructure. Over the last 10 years, however, a new market segment has made conforming to these guidelines more challenging than ever: drug delivery systems developed for new and innovative...
• Making the Most of Drug Development Data
  This quick, one-time registration gives you access to members-only site benefits. Drug development continues to change dramatically (see , below). As a result, the amount of information that pharmaceutical companies generate and collect during drug development doubles every five years...
• Making the Most of Drug Development Data
  This quick, one-time registration gives you access to members-only site benefits. For example, drug product lot data will need to be associated with production equipment and the state of that equipment (e.g., maintenance records). But the same lot data should also be associated with data...

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