Pharmaceutical Technology-03-02-2014

March 02, 2014

Changes in company ownership shake up the CMO industry.

March 02, 2014

Despite the progress made in nanomedicine development, there are several issues that remain unresolved. Raj Bawa, PhD, provides insight.

March 02, 2014

Quality-by-design principles enhance a thorough understanding of both product and process technology, which is needed for optimization of solid-dosage manufacturing, including processes for improving solubility, such as hot-melt extrusion, softgels, and liquid-filled capsules.

March 02, 2014

Manufacturers are taking measures to comply with new package safety rules.

March 02, 2014

The extended-release performance of drug-loaded pellets manufactured by two methods, drug layering and direct pelletization, was compared.

March 02, 2014

7900 ICP-MS Increases Efficiency

March 02, 2014

China's regulatory and compliance environment is set to change as the government declares a crackdown on bribery scandals.

March 02, 2014

Bioprocessors should understand the key factors associated with implementing single-use components or platforms, which include materials of construction, components, system design, and vendor support.

March 02, 2014

In this article, the authors demonstrate that a normal-phase chromatographic method was stability-indicating for a water-sensitive prodrug. The stress conditions using aqueous and non-aqueous conditions were also compared to understand the information obtained with each approach.

March 02, 2014

Accelerated testing and production create challenges in documenting product quality.

March 02, 2014

Using best practices for manual or automatic inspection can improve the inspection process.

March 02, 2014

Conference sessions from PDA and PharmTech expand educational opportunities at INTERPHEX 2014.

March 02, 2014

Nanomedicines can offer promising benefits in the diagnosis and treatment of diseases but there are still concerns about the safety and quality of these therapeutics partly because of the lack of clear regulatory guidance. Scott McNeil, PhD, director of the Nanotechnology Characterization Laboratory (NCL), spoke with Pharmaceutical Technology about nanomedicine characterization.

March 02, 2014

Advances in nanomedicine have provided several potential candidates for safe and effective delivery of siRNA.

March 02, 2014

Compact Mass Spectrometer Improves Analysis

March 02, 2014

With nanomedicines on the rise, a new class of non-biological complex drugs (NBCDs), which include nanosimilars, has emerged. As drug regulators are faced with the challenge of defining a framework to ensure the safe introduction of the follow-on nano-therapeutics, Stefan Muhlebach explains why NBCDs cannot be assessed using the standard generic or biosimilar approaches.

March 02, 2014

ACQUITY QDa Detector Increases Productivity

March 02, 2014

A survey on postapproval CMC changes was conducted to better understand reporting categories, nature and risks, and review outcomes.

March 02, 2014

The root cause of drug shortages is mismanagement of variation.

March 02, 2014

USP evaluates quality attributes for synthetic peptides.

March 02, 2014

The commercial availability of an increasing diversity of enzymes has led to the growing use of biocatalysts for API synthesis.

March 02, 2014

SALD-7500nano Expands Measurement of Nanoparticles

March 02, 2014

Trends driving pharmaceutical packaging include product protection, productivity boosters, and patient adherence improvement.

March 02, 2014

Click the title above to open the Pharmaceutical Technology March 2014 issue in an interactive PDF format.