Pharma’s Top 25: Trials, Tribulations, Technologies and Trend
2004 was a year marked by numerous regulatory troubles for Big Pharma, where the safety vs. efficacy debate reached new heights. Continuing mergers and consolidation, improving sales force effectiveness; changes under the Medicare Modernization Act; the looming dominance of China and India; and a new focus on pharma leadership were other significant developments.
By Sangita Viswanathan
The Latest in POP Technology
Crunch-melt, oral delivery of peptides and proteins, ODTs and controlled release continue to be the focus in the area of tablet technology. By Sangita Viswanathan
Silicones for Topical Pharmaceuticals
Unique physicochemcial properties help silicones achieve higher bioavailability, provide efficient vehicles for topical drug delivery and improve formulation aesthetics for better patient compliance.
By K. Ulman, D. Neun, L. Tan-Sien-Hee
Departments
REGULATORY REPORT
On the Docket
- A Standard for Clinical Trial Data:
Efficiencies that SDTM would bring to FDA should be mirrored in the pharmaceutical industry. By Edward J. Johnson, JD, CQA
QUALITY CONTROL
Supplier and Service Provider Audits
- An Opportunity for Change:
A reduction in the cost of supplier auditing will not necessarily reduce quality. By John Sullivan
QA/QC: Stability Testing
- Successful Strategies:
Properly planned, executed and managed stability studies are critical for understanding data generated during clinical trials.
Judy L. Carmody, Ph.D. and Stephen A. Smith, Ph.D.
GMP Notebook
- Quality Control Laboratories:
Control of testing laboratories is a never ending
concern. By Efrem H. Zaret, Ph.D.
FORMULATION
Nasal Drug Delivery
- Providing a Viable Alternative:
Nasal delivery offers multiple benefits such as fast onset, low dose, ease of delivery and increased compliance. By Sherry Dean
PHARM IT
- Making IT Work:
If a system doesn’t benefit you and your colleagues, it will fail.
By Dr. Martin Sumner-Smith
- Lab Analysis:
Particle Size Testing Optimizing Topical Formulations: Understanding variations in particle size and/ or zeta potential of raw materials can optimize manufacturing processes.
By Dr. Ana Morfesis and Dr. David Fairhurst
- What Matters?:
Know the factors influencing the accuracy of particle size
measurements. By Debra Sesholtz
- Lab Focus:
ELSD Techniques DMSO Transparency Using Low Temperature ELSD for HTS: Use of ELSD in the analytical laboratory is on the rise. By L. Loberger, M. Kruger, S. Bullock
Lab Notebook
- A Day at the Beach:
Generating data to meet deadlines without regard for cGMPs, or while being totally oblivious to cGMPs, is like going without sunscreen.
By Clifford L. Nilsen
