Industrial manufacturing of injectable drug products presents very different and difficult challenges when compared to other industrial manufacturing applications. In order to enhance patient safety and ensure product quality the Pharmaceutical Industry has been implementing systems called Advanced Aseptic Processing (AAP) systems. Advanced Aseptic Processing systems utilize advanced forms of a...

A simple, specific, accurate and precise spectrophotometric stability indicating method is developed for determination of itraconazole in the presence of its oxidative degradation product and in pharmaceutical formulations. A newly developed spectrophotometric method called ratio difference method by measuring the difference in amplitudes between 230 and 265 nm of ratio spectra. The calibration...

A new type of freeze-drying microscope based upon time-domain optical coherence tomography is presented here (OCT-FDM). The microscope allows for real-time, in situ 3D imaging of pharmaceutical formulations in vials relevant for manufacturing processes with a lateral resolution of <7 μm and an axial resolution of <5 μm. Correlation of volumetric structural imaging with product temperature measu...

Natural products are structurally and biologically interesting metabolites, but they have been isolated in minute amounts. The syntheses of such natural products help in obtaining them in bulk amounts. The recognition of microbial biotransformation as important manufacturing tool has increased in chemical and pharmaceutical industries. In recent years, microbial transformation is increasing sig...

Pharmaceutical manufacturers decry the purported burdens imposed by Federal regulation when it suits their proprietary interests, yet they sing a wholly different tune when defending product liability suits. As product liability defendants, they unabashedly seek the protective womb of Food and Drug Administration (FDA) regulation, arguing that agency approval of their drug and its labeling prec...

INTRODUCTION Imagine that CureCo, Inc., is the exclusive seller of a patented product that yields hundreds of millions of dollars per year in revenues. CopyCo International announces its intention to market the product and compete with CureCo. CureCo promptly sues CopyCo for patent infringement. A federal court holds that the patent is invalid, appearing to clear the way for CopyCo to enter the...

Corporate diversification allows for well-hidden financial ties between pharmaceutical and tobacco companies, which can cause a conflict of interest in the development and marketing of pharmaceutical products. In our investigation of tobacco company documents released and posted on the Internet as a result of the Master Settlement Agreement, we have found that these financial ties have fostered...

Process development organizations in modern pharmaceutical firms face the dual challenges of making clinical supplies under tight deadlines and developing a viable commercial manufacturing process at the same time. These two work processes are intertwined in complex ways, and often involve the work of many different teams. We propose a way to meet both requirements in a parallel and coordinated...

the purpose of this paper is to make explicit how companies in pharmaceutical sector can ensure their position in different markets by relying on a sustainable competitive advantages resulted from using a good defined marketing model. various factors are highlighted including high research and development roles and costs, hard government regulation in frame of gmp standard, market analysis tool...

Background and Aim: One of the complex processes in the Ministry of Health and Medical Education in Iran is the process of registering pharmaceutical supplies. Currently the registration process is a multi-stage process, resulting in parallel services, a waste of time and unnecessary expenses. Therefore, an integrated system will improve the relevant service delivery. The purpose of this study ...