Some of the heavy hitters in the pharmaceutical industry are going on crash diets, whacking their excess capacity carbs and opting for outsourcing as a means of reducing flab and building financial muscle.
By Sangita Viswanathan

Knowing unique PK profiles needed for the target product, using computer simulation and modeling techniques, results in reduced feasibility development time and enhances probability of success for controlled release products.
By Dr. Gopi Venkatesh

Presumptions commonly associated with automated workstations are misunderstood, exaggerated or simply wrong.
by Dale Vonbehren and Michele Boudreau

On The Docket
- Some Lessons Learned: Never underestimate the government’s resolve or
speculate on the timing of enforcement actions.
By Alan Minsk

- Integrating CMC into Drug Development - Part 2 : Chemistry, manufacturing
and controls include API synthesis, pre-formulation and formulation development,
analytical methods development and the preparation of clinical trial materials.
By Dr. David Bernstein

Supplier and Service Provider Audits
- Leveraging CAPA with Risk Management and Quality Control : The production
system and the quality system are one and the same.
By Joseph VinHais

- PAT and the Electronic Hand: Benefits from PAT can lead to faster times-to-market and perhaps faster review and release cycles for new drugs.
By John E. Carroll

- Facing New Regulatory Attention in Clinical Trials : Effective compliance programs are the best means to better manage regulatory risk.
By Mark Dewyngaert and Scott Willoughby

- Scientific Misconduct and Technology: eClinical technologies offer faster, more accurate access to data that enables clinical trial researchers to recognize and
prevent misconduct.
By Lise S. Richards

Lab Analysis: FTIR
- Increasing FTIR Usefulness: How can new advances in FTIR sampling
technology make your life easier?
By Shannon M. Richard and Dr. John Monti

LAB FOCUS:Microbiology - "I Need Results and I Need Them Now!" - By Tom Weschler

IT to Speed Development
- The Growing Scope of Records Management : The sheer volume of records,
especially from e-mails, makes comprehensive records management programs extremely challenging.
By Dr. Martin Sumner-Smith