Analytics

The US Food and Drug Administration has distributed a draft of Guidance for Industry: Residual Solvents in Drug Products Marketed in the United States for public comment.

Also, Ortho Biotech recalls one lot of "Procrit" due to cracked vials, more appointments at Actavis, more...

Also, Bilcare Global Clinical Supplies opens new headquarters in San Francisco, Sigurdur Oli Olafsson named CEO of Actavis Group, more...

Legislative decisions to increase Medicare's formulary may lead to a fight over drug approvals.

The authors propose an alternative to the USP disintegration test method. The method embraces physiological conditions of the oral cavity, as a screening tool for developing ODT products.

The authors consider several common techniques for verifying the accuracy of liquid-handling equipment and offer guidance for finding the appropriate technique for a given instrument.

Extractables and leachables are a growing concern for pharmaceutical manufacturers and regulatory bodies.

The high-profile case of contaminated heparin from a Chinese supplier has intensified the debate on the effectiveness of FDA's process for inspecting foreign drug-manufacturing facilities. The article examines proposed legislative and regulatory reforms and actions taken by the agency to improve drug-import safety.

Also, Cobra Biomanufacturing to extend collaboration and form joint venture with ViroMed, Epix Pharmaceuticals CEO resigns, more...

Senator Sherrod Brown sent a letter to Richard T. Clark, president and chief executive officer of Merck (Whitehouse Station, NJ), to ask for information about the company's reliance on global outsourcing for the manufacture of pharmaceutical ingredients and finished products.

Also, Niro changes its name to GEA Process Engineering; Frances K. Heller joins Exelixis as executive vice-president of business development, more...

Also, Roche to end HIV/AIDS research program, WuXi PharmaTech makes appointments, more...

Also, Catalent Pharma Solutions to collaborate with One World Design and Manufacturing Group, Bioheart appoints Howard J. Leonhardt as CEO, more...

The European Pharmacopeia Commission has published the General Information chapter "Potentially Genotoxic Impurities and European Pharmacopoeia Monographs on Substances for Human Use" in the July 2008 edition of PharmEuropa.

The European Pharmacopoeia Commission adopted revised monographs for heparin calcium and heparin sodium to strengthen the level of testing required for quality control.

Also, Covance and WuXi PharmaTech to form contract research joint venture in China, Covidien makes appointments to its Pharmaceutical Products and Imaging Solutions businesses, more...

Molecular Profiles created a poster that demonstrates the efficacy of its "nanoPASS" (nanoscale predictive analytical screening solution) technique to characterize an active pharmaceutical ingredient's (API) surface energy.

After a one-year delay in its implementation, the US Pharmacopeia Chapter 467 "Residual Solvents" is now official.

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.

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

Editors' Picks of Pharmaceutical Science & Technology Innovations

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.

In an assessment report about medicinal products containing heparin, the European Medicines Agency (EMEA)'s Committee for Medicinal Products for Human Use (CHMP) said it could not draw firm conclusions about the level of risk associated with unfractionated heparins (UFH) contaminated with oversulfated chondroitin sulfate (OSCS). Nevertheless, CHMP recommended that contaminated lots be withdrawn completely.

Also, Shire voluntarily recalls ADHD patch Daytrana

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

The authors demonstrate that anecdotal reports of prednisone tablet variability are inaccurate.