Pharmaceutical Technology-06-02-2013

Pharmaceutical Technology

Bills to regulate drug compounding and establish a national track and trace system face political and policy differences.

Pharmaceutical Technology

Roberto Darienzo, chief operating officer of Halo Pharmaceutical, describes strategic plans and industry trends.

Pharmaceutical Technology

Applying model-predictive methods and a continuous process-control framework to a continuous tablet-manufacturing process.

Pharmaceutical Technology

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.

Pharmaceutical Technology
Regulation & Compliance

June 02, 2013

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.

Pharmaceutical Technology
Global Feature

June 02, 2013

A unique demographic and payer mix make ASEAN an increasingly attractive region.

Pharmaceutical Technology
Insider Solutions

June 02, 2013

Companies can use metrics as a tool to help drive positive change and quality process improvements.

Pharmaceutical Technology

Editor's picks of pharmaceutical science and technology innovations in manufacturing and equipment.

Pharmaceutical Technology
API Synthesis & Manufacturing

June 02, 2013

Researchers at the Scripps Research Institute advance heteorcylic chemistry trhough new reagents and reaction-tracking techniques.

API Synthesis & Manufacturing
Pharmaceutical Technology

June 02, 2013

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.

Pharmaceutical Technology
From The Editor

June 02, 2013

Ranbaxy's $500 million settlement for producing adulterated drugs and fradulent data provides a cautionary tale for patients, FDA, and drug manufacturers.

Pharmaceutical Technology

Models and modeling software gain a foothold in solid-dosage manufacturing process design.

Pharmaceutical Technology
Troubleshooting

June 02, 2013

Crushing, fracturing, and bending tests quantify hardness.

Pharmaceutical Technology

Siegfried Schmitt discusses the European Commission's (EC) guidelines on Good Distribution Practice of Medicinal Products for Human Use

Pharmaceutical Technology

A multifaceted approach is needed to resolve the myriad of challenges in developing oral formulations of poorly soluble drugs.

Pharmaceutical Technology
Global Feature

June 02, 2013

The Taiwanese government engages in regulatory science in a move to boost its pharmaceutical sector.

Pharmaceutical Technology
Outsourcing Outlook

June 02, 2013

Approvals of new drugs are on an upward swing, but only a few CMOs are benefiting.

API Synthesis & Manufacturing
Pharmaceutical Technology

June 02, 2013

Microwave spectroscopy overcomes some of the limitations of circular dichroism and vibrational circular dichroism in analyzing enantiomers.

Regulation & Compliance
Pharmaceutical Technology

June 02, 2013

An overview of the latest regulatory developments for malaria drugs, biosimilars, and global standards.

Pharmaceutical Technology

The authors report on the range and distribution of grow-out times for biological indicators exposed to sublethal sterilization processes.

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.

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Pharmaceutical Technology

June 02, 2013

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