Pharmaceutical Technology, Jun 2, 2013 - Pharmaceutical Technology

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Pharmaceutical Technology, Jun 2, 2013
Cover Story
Using Model-Predictive Design in Solid-Dosage Manufacturing Processes
By Jennifer Markarian
Models and modeling software gain a foothold in solid-dosage manufacturing process design.
Model-Predictive Design, Control, and Optimization
By Fernando Muzzio , Ravendra Singh , Anwesha Chaudhury , Amanda Rogers , Rohit Ramachandran , Marianthi Ierapetritou
Applying model-predictive methods and a continuous process-control framework to a continuous tablet-manufacturing process.
API Synthesis & Manufacturing
Elucidating Heterocyclic Chemistry in Pharmaceuticals
By Patricia Van Arnum
Researchers at the Scripps Research Institute advance heteorcylic chemistry trhough new reagents and reaction-tracking techniques.
Microwave Spectroscopy for Enantiomeric Detection of Chiral Molecules
By Patricia Van Arnum
Microwave spectroscopy overcomes some of the limitations of circular dichroism and vibrational circular dichroism in analyzing enantiomers.
Small-Molecule Drug Development: Recent Study Suggests Limited Binding Sites
By Patricia Van Arnum
A recent study of computer-created and natural proteins suggests the number of sites where small-molecule drugs can bind to proteins is limited, thereby narrowing how to mitigate side effects through drug design.
Special Report: Drug Delivery
Drug Delivery Insights: Strategies for Solubility and Bioavailability Enhancement of Poorly Soluble Drugs
Kurt Nielsen, PhD, chief technology officer and senior vice-president of R&D at Catalent Pharma Solutions, discusses strategies for solubility and bioavailability enhancement of poorly water-soluble drugs.
Industry Perspectives: Achieving Solutions for the Challenge of Poorly Water-Soluble Drugs
By Adeline Siew, PhD , Patricia Van Arnum
A multifaceted approach is needed to resolve the myriad of challenges in developing oral formulations of poorly soluble drugs.
Peer-Reviewed Research
Methods for Identifying Out-of-Trend Results in Ongoing Stability Data
By Adrijana Torbovska , Suzana Trajkovic-Jolevska
The authors discuss three methods for identification of out-of-trend (OOT) results and further compare the z-score method and the tolerance interval in OOT analysis for stability studies.
Understanding Biological Indicator Grow-Out Times—Part II
By John R. Gillis , Gregg A. Mosley , John B. Kowalski , Garrett Krushefski , Paul T. Nirgenau , Kurt J. McCauley , Philip M. Schneider
The authors report on the range and distribution of grow-out times for biological indicators exposed to sublethal sterilization processes.
Troubleshooting
Measuring Tablet Hardness: A Primer
By Eric Chiang
Crushing, fracturing, and bending tests quantify hardness.
Outsourcing Outlook
Drug Approval Trends Don't Extend to CMOs
By Jim Miller
Approvals of new drugs are on an upward swing, but only a few CMOs are benefiting.
Insider Solutions
The Meaning of Metrics
By Susan J. Schniepp
Companies can use metrics as a tool to help drive positive change and quality process improvements.
Global Feature
Report from Southeast Asia
By Jill E. Sackman
A unique demographic and payer mix make ASEAN an increasingly attractive region.
Report from Taiwan
By Jane Wan
The Taiwanese government engages in regulatory science in a move to boost its pharmaceutical sector.
Regulation & Compliance
Regulatory Roundup
By Jill Wechsler
An overview of the latest regulatory developments for malaria drugs, biosimilars, and global standards.
Congress Considers Legislation to Secure Drug Supply Chain
By Jill Wechsler
Bills to regulate drug compounding and establish a national track and trace system face political and policy differences.
A Lifecycle Approach to Process Validation
By Sean Milmo
A science- and risk-based approach to verify and demonstrate that a process operating within predefined specified parameters consistently produces material that meets all its critical quality attributes.
From The Editor
Trust in the Pill Bottle
By Rita Peters
Ranbaxy's $500 million settlement for producing adulterated drugs and fradulent data provides a cautionary tale for patients, FDA, and drug manufacturers.
Industry Leaders
Q&A with Roberto Darienzo, Halo Pharmaceutical
Roberto Darienzo, chief operating officer of Halo Pharmaceutical, describes strategic plans and industry trends.
In the Spotlight
Product Spotlight: Manufacturing and Equipment
Editor's picks of pharmaceutical science and technology innovations in manufacturing and equipment.
Ask the Expert
The EU Changes Guidelines for Good Distribution Practices
Siegfried Schmitt discusses the European Commission's (EC) guidelines on Good Distribution Practice of Medicinal Products for Human Use

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Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
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