Pharmaceutical Technology-06-02-2013
Pharmaceutical Technology
Congress Considers Legislation to Secure Drug Supply Chain
June 02, 2013
Regulation & Compliance
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Bills to regulate drug compounding and establish a national track and trace system face political and policy differences.
Q&A with Roberto Darienzo, Halo Pharmaceutical
June 02, 2013
Industry Leaders
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Roberto Darienzo, chief operating officer of Halo Pharmaceutical, describes strategic plans and industry trends.
Model-Predictive Design, Control, and Optimization
June 02, 2013
Cover Story
37
6
Applying model-predictive methods and a continuous process-control framework to a continuous tablet-manufacturing process.
Methods for Identifying Out-of-Trend Results in Ongoing Stability Data
June 02, 2013
Peer-Reviewed Research
37
6
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.
A Lifecycle Approach to Process Validation
June 02, 2013
Regulation & Compliance
37
6
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.
Report from Southeast Asia
June 02, 2013
Global Feature
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A unique demographic and payer mix make ASEAN an increasingly attractive region.
The Meaning of Metrics
June 02, 2013
Insider Solutions
37
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Companies can use metrics as a tool to help drive positive change and quality process improvements.
Product Spotlight: Manufacturing and Equipment
June 02, 2013
In the Spotlight
37
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Editor's picks of pharmaceutical science and technology innovations in manufacturing and equipment.
Elucidating Heterocyclic Chemistry in Pharmaceuticals
June 02, 2013
API Synthesis & Manufacturing
37
6
Researchers at the Scripps Research Institute advance heteorcylic chemistry trhough new reagents and reaction-tracking techniques.
Small-Molecule Drug Development: Recent Study Suggests Limited Binding Sites
June 02, 2013
API Synthesis & Manufacturing
37
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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.
Trust in the Pill Bottle
June 02, 2013
From The Editor
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Ranbaxy's $500 million settlement for producing adulterated drugs and fradulent data provides a cautionary tale for patients, FDA, and drug manufacturers.
Using Model-Predictive Design in Solid-Dosage Manufacturing Processes
June 02, 2013
Cover Story
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Models and modeling software gain a foothold in solid-dosage manufacturing process design.
Measuring Tablet Hardness: A Primer
June 02, 2013
Troubleshooting
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Crushing, fracturing, and bending tests quantify hardness.
The EU Changes Guidelines for Good Distribution Practices
June 02, 2013
Ask the Expert
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Siegfried Schmitt discusses the European Commission's (EC) guidelines on Good Distribution Practice of Medicinal Products for Human Use
Industry Perspectives: Achieving Solutions for the Challenge of Poorly Water-Soluble Drugs
June 02, 2013
Special Report: Drug Delivery
37
6
A multifaceted approach is needed to resolve the myriad of challenges in developing oral formulations of poorly soluble drugs.
Report from Taiwan
June 02, 2013
Global Feature
37
6
The Taiwanese government engages in regulatory science in a move to boost its pharmaceutical sector.
Drug Approval Trends Don't Extend to CMOs
June 02, 2013
Outsourcing Outlook
37
6
Approvals of new drugs are on an upward swing, but only a few CMOs are benefiting.
Microwave Spectroscopy for Enantiomeric Detection of Chiral Molecules
June 02, 2013
API Synthesis & Manufacturing
37
6
Microwave spectroscopy overcomes some of the limitations of circular dichroism and vibrational circular dichroism in analyzing enantiomers.
Regulatory Roundup
June 02, 2013
Regulation & Compliance
37
6
An overview of the latest regulatory developments for malaria drugs, biosimilars, and global standards.
Understanding Biological Indicator Grow-Out Times—Part II
June 02, 2013
Peer-Reviewed Research
37
6
The authors report on the range and distribution of grow-out times for biological indicators exposed to sublethal sterilization processes.
Drug Delivery Insights: Strategies for Solubility and Bioavailability Enhancement of Poorly Soluble Drugs
June 02, 2013
Special Report: Drug Delivery
37
6
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.
Pharmaceutical Technology, June 2013 Issue (PDF)
June 02, 2013
Issue PDF
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Click the title above to open the Pharmaceutical Technology June 2013 issue in an interactive PDF format.