The economic implications of international patent harmonization have attracted little empirical scrutiny. Based on patent application and renewal data in major European countries since the early 1980s, this paper examines the empirical relationship between international patenting, R&D, and “trade flows” of patent rights across national borders. The analysis reveals a substantial patent “trade i...

The objective of the current study is to develop a validated, specific and stability-indicating reverse phase liquid chromatographic method for the quantitative determination of genotoxic impurities in the drug substance imatinib mesylate. This report includes a brief review of the toxicology of impurities in imatinib mesylate and the strategies used to set acceptance criteria for genotoxic imp...

A rapid, precise, sensitive, economical, and validated high performance thin layer chromatographic method is developed for simultaneous quantification of olmesartan medoxomil and hydrochlorothiazide in combined tablet dosage form. The method used amlodipine as internal standard (IS). Chromatographic separations were achieved on silica gel 60 F254 plates using toluene-methanol-ethyl acetate-acet...

portant part of the drug development process, and the pharmaceutical industry’s considerable interest in this topic has led to the publication of an article by the Pharmaceutical Research and Manufacturer’s of America (PhRMA) in Pharmaceutical Technology (1). Although the concept of stress testing is not new to the pharmaceutical industry, the procedure was not clearly defined until the Interna...

Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing doxycycline hyclate are reviewed. According to the Biopharmaceutics Classification System (BCS), doxycycline hyclate can be assigned to BCS Class I. No problems with BE of IR doxycycline formulations containing different ...

The most recent FDA (1) and International Conference on Harmonization (ICH) (2-4) guidance documents advocate a new paradigm of process validation based on process understanding and control of parameters and less on product testing. Consequently, the means of determining criticality has come under greater scrutiny. The FDA guidance points to a lifecycle approach to process validation (see Figur...

The present work reports a rapid reversed-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous determination of 12 beta-lactam components for cleaning validation and cross-contamination. A strategic experimental approach was implemented for the method development. The desired chromatographic separation was achieved on a Symmetry C18 (4.6 X 75 mm, 3.5 μm) column usi...

Drugs with low water solubility are predisposed to poor and variable oral bioavailability and, therefore, to variability in clinical response, that might be overcome through an appropriate formulation of the drug. Polymorphs (anhydrous and solvate/hydrate forms) may resolve these bioavailability problems, but they can be a challenge to ensure physicochemical stability for the entire shelf life ...

For approval of a drug product, the United States Food and Drug Administration (FDA) requires that substantial evidence of the effectiveness and safety of the drug product be provided through the conduct of two adequate, well-controlled clinical trials. To assist the sponsors in preparation of final clinical reports for regulatory submission and review, the FDA and other regulatory agencies and...

BACKGROUND To understand the degradation behavior of diacerein and to develop a simple, rapid, sensitive, and validated RP-HPLC method for the determination of diacerein, in the presence of its degradation products. MATERIALS AND METHODS An accurate, sensitive, precise, rapid, and isocratic reversed-phase high-performance liquid chromatography (RP-HPLC) method, equipped with a photo-diode arr...