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Clinical Pharmacology & Therapeutics Journal ~ Volume 85, Issue 5, May 2009

This issue discusses drug delivery and how advances in the pharmaceutical sciences and other scientific fields have enabled substantial progress in this field. Targeting the best route or providing a variety of routes of drug administration presents an array of benefits, such as enhanced drug administration and bioavailability, improved patient acceptance and compliance, decreased toxicity, and precise therapeutic targeting. Technologies enabling drug delivery are now commonly used to create and extend markets, and the pharmaceutical industry is turning to drug delivery to extend the revenueearning lifetime of their biggest products. Growth opportunities for drug delivery systems extend into all therapeutic classes of pharmaceuticals and encompass a wide range of compounds and formulations, presenting many options in the world market. The discovery of better delivery systems in conjunction with the discovery of novel pharmacological compounds will advance disease diagnosis and treatment.

In This Issue

Top of pageRegulating combination products

The US Food and Drug Administration (FDA) guidance on medical devices ensures the safety, efficacy, and security of drugs released to the public. The introduction of combination products has convoluted the approach historically used by the FDA to regulate single-entity products. Lauritsen details the complications faced by the agency in regulating combination products and the most important issues that must be addressed. See page 468

Top of pageAppraising the safety and efficacy of drug-eluting stents

The use of drug-eluting stents (DESs) in procedures has significantly increased worldwide since their approval by the US Food and Drug Administration in 2003. Although DESs are considered superior to bare-metal stents, safety concerns remain in the wake of reports of late stent thrombosis and myocardial infarction. In response to these concerns, new-generation DESs have been approved and made available for use. Using published clinical data, Maluenda et al. appraise the safety and efficacy of several DESs. See page 474

Top of pageEffect of multiple alleles on efavirenz disposition

Efavirenz (EVF), a non-nucleoside reverse transcriptase inhibitor used for treatment of HIV-1 infection, is primarily metabolized by CYP2B6. Although CYP3A4/3A5 has also been associated with higher EVF exposure, the influence of CYP2A6 polymorphism on EVF pharmacokinetics has not yet been determined. Arab-Alameddine et al. discuss the impact of multiple alleles on EVF disposition. See page 485

Top of pageThe growing role of nanoparticles in brain tumor diagnosis and therapy

Nanoparticle-based contrast agents designed for use in diagnosing brain tumors using magnetic resonance imaging (MRI) are capable of providing better information on the extent of tumor. The potential to visualize portions of tumors usually not detectable with conventional MRI makes nanoparticles of interest for advancing the diagnosis, operative management, and adjuvant therapy of brain tumors. Orringer et al. discuss the application of nanoparticles to brain tumor diagnosis and therapy and the many reasons that nanoparticles offer the next frontier in the treatment of brain tumors. See page 531

Top of pageBiologics in cardiovascular regenerative medicine

Stem cell–based cardiovascular regenerative medicine plays an integral role in therapy aimed at achieving structural and functional repair of the myocardium. Although experience gained in the clinical setting has shown stem cell–based cardiovascular regenerative medicine to be feasible and safe, the structural and functional benefits of such therapy have not yet reached their full potential. The very low rate of cell retention by the recipient myocardial tissue justifies review of the accumulated data to guide future developments aimed at overcoming this limitation and achieving a better outcome of stem cell delivery. See page 548

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