Drug Development

This review article explains how self-emulsifying drug delivery systems can increase the solubility and bioavailability of poorly soluble drug.

The authors developed a method to accurately measure the average molecular weight of large poly(ethylene glycols) (PEGs) using ion-mobility time-of-flight mass spectrometry coupled with gas-phase ion–molecule reactions.

A roundtable with John Doney, Jiao Yang, Hans Baer, and Elena Draganoiu.

The authors describe the factors affecting reconstitution time of dry powder for injection and classifies them as intrinsic and extrinsic parameters.

Clear labels for substances that can be used as excipients, APIs, or both are critical to end-product use.

Polyethylene glycol (PEG) conjugation is a highly effective technical and commercial strategy to develop macromolecules. The authors explain the benefits and process of PEGylation and how it may be applied to small molecules.

With no economic relief in sight, industry, like all of us, is grappling with high-and new-costs.

The year 2007 was slow for approvals for new molecular entities and overall pharmaceutical industry growth. Big Pharma seeks relief in a growing biologics portfolio.

At first glance, the title of this article may bring a wry smile to the face of many an astute practitioner, but I can provide 'documentary evidence' that free validation is not a just a play on words, but a financial reality.

The introduction of biomolecules into cells is a key technology for research in biological sciences.

How can any company be sure that the standards that suppliers might claim to operate, and might be able to demonstrate from time to time, are actually being practised all the time?

The US Pharmacopeia (USP) posted revised monographs for heparin sodium and heparin calcium on its website.

Also, Stiefel Laboratories will acquire Barrier Therapeutics, Danube Pharmaceuticals appoints Brian Levy COO, more...

Also, Patheon to expand Puerto Rico facility, Creabilis Therapeutics appoints Tony Wilson CEO, more...

Effective July 1, 2008, the Office of Generic Drugs (OGD) will require abbreviated new drug applications (ANDAs) to include data that demonstrate the manufacturer's control of residual solvents.

Also, Shire voluntarily recalls ADHD patch Daytrana

Also, Pall plans expansion in South America, Anthony Clarke joins Alexza Pharmaceuticals, more...

The US Food and Drug Administration advised patients, caregivers, and healthcare professionals to switch to hydrofluoroalkane-propelled albuterol inhalers now because chlorofluorocarbon-propelled inhalers will not be available in the US after Dec. 31, 2008.

Antibody drug conjugates offer a niche opportunity in drug development and contract manufacturing.

Creating a kinder, gentler manufacturing process that doesn't kill the product is the goal of process developers doing large-scale cell culture for cell therapy.

Nanoparticle-based systems present many advantages for the delivery of current and emerging biological drugs.

Letting the public inside the drug development process may increase their faith in what we do.

The good, the bad, and the ugly about direct-to-consumer advertising.

Scientists are uncovering signaling systems that operate via cannabinoid messenger molecules.

An ambitious survey of characterization techniques presents current information.

When drugs are encapsulated, electrification (the electrostatic charge of the capsule) may sometimes cause problems, such as capsule adhesion during transportation or dispersion of the capsule content in the filling process.

Also, GVK BIO and Wyeth Pharmaceuticals form research agreement, Eli Lilly announces changes to management, more...

The European Federation of Pharmaceutical Industries and Associations (EFPIA), the trade association representing European pharmaceutical manufacturers, issued recommendations to the public consultation launched in March by the European Commission's proposed drug anticounterfeiting measures. EFPIA's proposal includes a ban on drug repackaging.

Also, Pfizer to close Indiana "Exubera" facility, executive appointments at Patheon, more...

Also, Quintiles Transnational to acquire Eidetics, ChemAxon appoints Alex Drijver CEO, more...