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 Features
 
Nearly 100 medicines for sale in the U.S. have now received pediatric labeling reversing a period when not enough studies were being done in this population. This welcome development follows recent legislation to provide incentives for drug makers who focus on the pediatric segment.
The Case for Pediatric Formulations: The rights of children are coming to the forefront and altering the way clinicians, politicians and policy-makers view this vulnerable segment of population.
By Dr. Jon Bruss, MD, MSPH, FAAP
Knowing their products and customers well is helping many suppilers offer value-added formuation development services.
By Sangita Viswanathan
The pairing of the ESI/oa-TOF/MS and ion trap ESI/MS/MRM solves a number of vexing problems encountered in pharmaceutical formulation analysis.
By Edgar Nagele and Ralf Moritz
Degradation Analysis: From API Synthesis to Commercial Product
By Dr. Margaret McClure, Brian Lane and Joe Ludwig
 
 
     
 
 Departments
REGULATORY REPORT
On The Docket
- Access to Information for QA/RA Professionals: Services used by attorneys may also be useful to pharmaceutical quality and regulatory professionals.
By Edward J. Johnson
 
FORMULATION
Drug Delivery
- Evolution of Transdermal Drug Delivery: Recent progress in active transdermal drug delivery technologies has helped miniature, powerful devices to generate required clinical responses.
By Drs S.A. Jones and M.B. Brown
 
 
Excipient Focus: Lipids
- Liposome Formulations of Sparingly Soluble Compounds:Liposome technology offers many advantages for formulation of sparingly soluble compounds.
By Drs D. Reimer, S. Eastman, C. Flowers, A. Boey, T. Redelmeier and Ms. C. Ouyang
 
     
 
QUALITY CONTROL
Foreign Object Detection
- Magnetic Separation: How to select the best metal detector?
By Bill Dudenhoefer
GMP Notebook
- Control of Components - A Look to the Past: Take a minute to lok back and understand current practices and procedures.
By Dr. Efrem H. Zaret
 
     
 
PAT TOOLBOX
PAT Standards
- Standards Processes at ASTM: ASTM's International Committee EFF defines standards development for pharaceutical manufacturing.
By Pat Picariello and Carolyn Sheahan
 
     
 
REGULATORY COMPLIANCE
Training
- Making the Compliance and Procedural Training Touchdown: Companies have to be good at blocking and tackling to achieve winning compliance.
By Mark Starke

- Trials and Tribulations behind Training Initiatives: Assess, align, deploy, measure and reinforce-five steps to cultivating talent and skills in your organization
By Carol Ann Weiss & Suzanne Rabauer

 
     
 
IN THE LAB
Lab Analysis: Sample Prep
Sample Preparation for Water Activity Analysis: It is important to understand the effects of sample preparation on water activity.
By Dr. Anthony Fontana
Laboratory Water Challenges: Selection, installation, qualitfication and maintenance of a water purification system are key factors that present a unique challenge.
By Sean Murphy, Morgan Norris and Bruno Rossi

LAB NOTEBOOK
- Laboratory Safety - It's the Law: The OSHA Laboratory Standard can be applied successfully to any laboratory.
By Clifford L. Nilsen

 
     
 
PHARMA IT
Electronic Records Management
- Control or be Controlled:The time is now to take a hard, careful look at your record retention policy.
By Tamar M. June
- After GMP and GLP, it's time for Good Clinical Practices: Increased clinical research data complexity and volume have resulted in greater need for electronic records management.
By Mark S. Ferrero
RFID
- An End-to-End Approach: RFID technologies can improve process quality and provide comprehensive protection against counterfeiting
By Wolf Bielas
 
     
 
 
 
 
 
 
   
 
 
 
 
 
 
 
   
           
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