Drug Development

FDA published its long-awaited guidance titled Process Validation: General Principles and Practices this week.

Merck Teams with Parexel; Roche CFO to Retire; and More

FDA issued a draft guidance for industry on Jan. 18, 2011, about the size of beads within drug products labeled for sprinkle.

A company's contamination-control plan is an important document designed to formalize the rationale, methods, and validation of contamination-control procedures in a manufacturing facility. The author describes the role of bioburden in the contamination-control plan.

Improvements in analytical techniques may call for a re-evaluation of the biopharmaceutical industry saying that "the process is the product."

During the past few years, we've seen a growing interest in direct oral application products, evidenced by the large amount of products already available on the market.

Iain Moore explains what progress has been made so far regarding EU plans to regulate excipients.

Biologics are large molecular weight molecules primarily formulated for parenteral administration; however, there are some smaller biomolecules that have been formulated for oral use.

Excipients should be regulated to manage risk. Although, excipients are an integral part of a finished pharmaceutical product, the issue of regulation is complex.

Gilead Sciences to Acquire Arresto Biosciences; Sartorius Appoints Head of Lab Business; and More.

Contract manufacturers strengthen their toolboxes and partnerships as they navigate the changing drug-development model.

The European Commission and Medicines Agency seem to be moving in advance of their ICH partners to update standards.

Expert and implementation working groups harmonize more guidelines and move Q11 forward.

Capable of great works, pharma as a whole still yields to the lesser angels of its nature.

Developments in RNAi, monoclonal antibodies, and more are boosting the biotech marketplace.

The manufacture of orally dissolving films is done by various methods such as solvent casting, hot-melt extrusion, semisolid casting, solid-dispersion extrusion, and rolling. The authors discuss these methods and the various parameters in which dissolving films are evaluated.

Poor organization makes it hard for readers to find the helpful information in a recent book.

Analysis of crospovidone as a superdistingrant.

The main drivers for innovation in film coatings in the last 5 years mainly relate to optimising the film coating process itself, as well as to the need for film coating materials with enhanced functionality.

Excipient purity is critical in all applications of drug formulation. Typically, the more sensitive or reactive an API, the more critical excipient purity becomes.

AstraZeneca and Abbott End Program; PhRMA Elects New Members; and More.

Pfizer Recalls One Lipitor Lot; Sanofi Aventis Names Head of R&D; and More.

Thermo Fisher to Acquire Dionex; Former SOCMA CEO Joe Acker Dies; and More.

Company and People Notes: GlaxoSmithKline acquires Nanjing MeiRui Pharma; Cephalon's CEO to remain on medical leave; and more.

Supportive public policy is needed in order for innovation to flourish.