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Featured Articles
PAT: A New Dawn for Drug Product Quality
Leading experts share insight on the current and future direction of process analytical technology. This article contains bonus online material.
Cushioning pharma's fall from the patent precipice
Pharma faces imminent expiries of key patents and increasing competition from generics. To protect what they already have, or what they will invent or acquire, companies must give patent protection the attention it deserves.
Implications and Opportunities of Applying QbD Principles to Analytical Measurements
The authors present two concepts to improve robustness and facilitate continuous improvement in analytical methods. This article contain bonus online material.
Trends and challenges of biopharma manufacturing
The whole pharma/biopharma industry is under pressure to deliver cost-effective new drugs; however, the number of new drug applications is getting lower as the size of investment is increasing.
Inside Outsourcing 2009
Six articles and an industry roundtable focused on global outsourcing, from the editors of Pharmaceutical Technology, Pharmaceutical Executive, Applied Clinical Trials, and BioPharm International.
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Pharma packs a punch
Another Boost for Vaccines
Rodney Dangerfield and R&D
Federal Spending Freeze Could Threaten Supply-Chain Security
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Industry Leaders: Q+A
AAI Pharma's Lee Karras talks about contract-service demand.
Plus, novel dosage forms and emerging trends.
Survey
What factor do you think will be most significant in 2010 for determining the health of the market for contract manufacturing of active pharmaceutical ingredients?
The global economic recovery
The US economic recovery
Improved credit and financing flow to the small to emerging pharma/bio sector
Less restrictive inventory control by pharmaceutical companies
The level of competition from contract manufacturers in emerging markets
The global economic recovery
40%
The US economic recovery
14%
Improved credit and financing flow to the small to emerging pharma/bio sector
14%
Less restrictive inventory control by pharmaceutical companies
9%
The level of competition from contract manufacturers in emerging markets
24%
View Results
Regulatory Corner
Standards & Regulations
Managing Change Control in a Changing Environment
We never thought implementing complex changes could become more cumbersome.
Inside PIC/S: Implementing Quality Risk Management
Representatives to the PIC/S provide an example of methodology for implementing ICH Q9.
Manufacturers Look to Vaccines for Growth and Innovation
Vaccine R&D is surging, but continues to raise manufacturing and regulatory challenges.
Regulatory Roundup: FDA Releases Annual Guidance Agenda; OMB Urges Obama to Issue Revised Executive Order.
FDA Releases Annual Guidance Agenda; OMB Urges Obama to Issue Revised Executive Order.
Eric LangerOutsourcing OutlookEric Langer A Bio View of Outsourcing
Patricia Van ArnumIngredients InsiderPatricia Van Arnum Advances in Custom Synthesis
Faiz kermaniSpotlightFaiz Kermani EU pricing dilemmas
Faiz kermaniStatistical Solutions Lynn Torbeck%RSD: Friend or Foe?
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