Analytics

The author assesses the power and limitations of NIR chemical imaging and its future.

Bioanalysis has migrated from a very general vocation to one that requires more specialization, particularly in GLP applications.

X-ray powder diffraction (XRPD) is a key analytical technique in the pharmaceutical industry, providing direct information about the crystalline and amorphous components in pharmaceutical formulations in a non-destructive manner and without laborious sample preparation.

NIR chemical imaging is based on the same principles as NIR spectroscopy, but uses a focal plane array detector in place of a single detector element to capture the spectral signature at tens of thousands of spatially resolved positions simultaneously.

Having been directly involved in the evolution of dissolution testing since its introduction in the early 1970s and variously representing Hanson, Van Kel, Sotax and Erweka prior to developing our own range of dissolution testers in 2002, I would have to say that advances in dissolution testing technology have been one of the biggest breakthroughs in solid dosage form testing over the last decade.

Charles River Acquires WuXi AppTec; Amgen Appoints President and COO; and More.

FDA Issues Warning Letters to Astellas, GSK, And Novartis; Sandoz Acquires Oriel Therapeutics; And More.

Cephalon Completes Acquisition of Mepha; Xcellerex Appoints President and CEO; and More.

The US Pharmacopeial Convention welcomed Minghao Zhou of China's Zhejiang Provincial Institute for Food and Drug Control.

Eli Lily Wins Court Battle; Genzyme Appoints COO; And More.

The Agilent 2100 Bioanalyzer plus the Agilent High Sensitivity Protein 250 Kit automatically detects and quantifies protein impurities down to 0.05% ? meeting ICH guideline Q3B(R2)!

In Part I of this article, which appeard in the March 2010 issue, the authors describe their approach for constructing form spaces for carbamazepine, cimetidine, and phenylbutazone by initial solvent screening to evaluate the feasibility of spherical crystallization. Part II of this article discusses their findings.

As the industry continues to evolve, do we know where we're headed?

Laboratory personnel share interesting tales as well as stories of unexpected tails.

The authors examined the disintegration and dissolution profiles of propranolol and rofecoxib tablets overencapsulated with standard hard-gelatin capsules and with capsules specifically designed for double-blind clinical trials.

Editors' Picks of Pharmaceutical Science and Technology Innovations

As demand for global vaccine development and production grows, all eyes are turning to Asia.

The authors describe a novel approach for assessing method robustness. This article contains online-bonus material and was copublished with Pharmaceutical Technology Europe.

Interphex Showcase 2010.

The BIO convention, and healthcare reform, could re-energize biotech.

Pharmaceutical Technology's annual survey on equipment and machinery reveals the spending levels and types of spending made in 2009 and planned for 2010.

Could insect cells offer a faster way of manufacturing pandemic influenza vaccines compared with traditional egg-based methods? According to researchers at the Vienna Institute of BioTechnology (Austria), their new technique could help a virus-like particle (VLP) vaccine to reach the market within 3 months from the first isolation of a new influenza strain - traditionally produced vaccines take approximately 6 months.

Vibrational spectroscopy, which encompasses near-infrared, mid-infrared and Raman spectroscopy, is an important analytical tool in the pharma industry.

Biotechnology company Genzyme reported that FDA notified the company that it intends to take enforcement action to ensure that products are made in compliance with good manufacturing practice (GMP) regulations.

Pfizer Invests In Nodality; SOCMA Approves New Members; And More.

Merck Ends Partnership With Dynavax; PhRMA Elects Officers; And More.

Abbott Agrees to Acquire Facet Biotech; FDA Issues Black-Box Warning For Plavix; and More.

The World Health Organization released new guidelines this week for the treatment of malaria and the first-ever guidelines on procuring safe and efficacious antimalarial drugs.

Exelixis And XenoPort Announce Job Cuts; GSK Dedicates India Facility; And More.

The US Food and Drug Administration recently published guidance for the characterization and qualification of cell substrates, viral seeds, and other biological materials used to manufacture viral vaccines for human use.