Analytics

Sanofi-aventis (Paris) has asked Genzyme to stand aside and let the shareholders decide on whether an acquisition should take place.

The European Medicines Agency published a draft list of questions and answers on postapproval change-management protocols last week.

The growth in pharmaceutical outsourcing is creating a more complex and risky supply-chain environment, according to a report issued last week.

sanofi acquires BMP Sunstone; DCAT Names President; and More.

Pfizer (New York) announced on Oct. 29, 2010 that it intends to recall two additional lots--approximately 38,000 bottles--of Lipitor (atorvastatin calcium) 40 mg tablets distributed in the United States.

From fiscal year 2007 to 2009, the US Food and Drug Administration increased the number of foreign drug inspections it conducted, but the agency still conducted fewer foreign inspections than domestic inspections each year, according to a recent report by the US Government Accountability Office (GAO).

FDA Holds Biosimilars Public Hearing

Editors' picks of pharmaceutical science and technology innovations.

A recent book offers an excellent overview of cleaning validation.

A conversation with Mike de la Montaigne, president of Eisai Machinery, USA Inc., about the possibilities for conducting fully automated product inspections.

As technology advances, industry's needs are growing.

The authors describe a modified version of the Large-N test used to determine content uniformity.

The author examines the process of method development, with reference to ISO 13320:2009 and relevant monographs from the United States and European pharmacopoeias.

Applied statisticians are forever searching for the enemy of quality-variability.

Although there are no regulatory requirements or established pharmacopoeial techniques for the dissolution testing of inhaled drugs, such testing can potentially open up the opportunity to tailor formulation properties.

PPD and Bend Research Form Collaboration; Ricerca Makes Senior Appointment; And More.

Pfizer Forms Pact with Biocon; Baxter Makes Appointments; And More.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the October 2010 edition from EMD Millipore and Sartorius.

sanofi to Cut 25% of US Workforce; AMRI Names VP of Chemical Development; And More.

Company and People Notes: Novartis Settles with US Attorney's Office; Hospira Names VP, And More.

The reopened debate over embryonic-stem-cell research could stifle many other scientific pursuits.

Editors' picks of pharmaceutical science and technology innovations.

The advantages of coupling hot melt extrusion technology with online FT-NIR spectroscopy are explained.

The authors describe the operational requirements and design of a process-ready PAT-based IBD system.

The author discusses new detection-system technologies that can improve performance and provides key criteria to consider when selecting or upgrading a system for pharmaceutical use.

Several industry experts describe applications in pharmaceutical applications, including on-line total organic carbon analysis, ultra-fast liquid chromatography, rapid microbial testing, and differential scanning calorimetry-Raman Spectroscopy.

The author outlines key considerations for carrying out a structured approach to monitoring process performance and ensuring product quality.

The author describes the development of small-angle X-ray scattering and analyzes its advantages in the characterization of drug-delivery systems and large molecules. This article is part of a special Analytical Technology issue.

The authors discuss the approach taken to develop a new calibration approach, its associated protocols, and how it can be used to calculate data.

The authors review and discuss the influence of glycans on the conformation of a representative IgG1 biopharmceutical using H/DX-MS as an analytical tool.