I began to wonder about the larger question of whether there was any ethical obligation of these pharmaceutical companies to develop, produce or supply medicinal products to markets that either cannot afford them or that are too small to bring a return on the investment. After all, few would argue that a computer company has a moral obligation to develop a product for a small unprofitable marke...

Aimed at analyzing the continuity of core competence in a core field, the behavior of 11 Japanese pharmaceutical firms over the last two decades was analyzed. This study demonstrates that firms could maintain originality as a core competence in ongoing new product development (NPD) by utilizing a licensed alliance product as a tool for maintaining or injecting this originality. This finding was...

The control of impurities in Formulated products and Active Pharmaceutical ingredient’s were regulated by various regulatory authorities like US-FDA,ICH,MHRA,TGA etc.As per International Conference on Harmonization guidelines, the Impurity may be defined as any component of new drug product that is not the drug substance or an excipient in drug product. Nowadays apart from purity profile there ...

www.pharmtech.com yophilization or freeze-drying is often used to stabilize various pharmaceutical products, including virus vaccines, protein and peptide formulations, liposome, and small-chemical drug formulations (1–4). Often a pharmaceutical product may be susceptible to physical and chemical degradation when stored as a ready-to-use solution. The goal of the formulations scientist is to id...

Substantial changes in Pharmaceutical R&D strategy are required to address existing issues of low productivity, imminent patent expirations and pressures on pricing. Moves towards personalized healthcare and increasing diversity in the nature of portfolios including the rise of biopharmaceuticals however have the potential to provide considerable challenges to the establishment of cost effectiv...

The present article gives an introduction and general overview on process validation of pharmaceutical manufacturing process especially tablet manufacturing process. The principal objective of dosage form design is to achieve a predictable therapeutic response to a drug included in a formulation which is capable of large scale manufacture with reproducible product quality. Solid dosage forms in...

Informatics infrastructure plays a crucial role in supporting different decision making activities related to pharmaceutical product development, ilot plant and commercial scale manufacturing by streamlining information gathering, data integration, model development and managing all hese for easy and timely access and reuse. The foundation of such an infrastructure is the explicitly and formall...

Introduction Total organic carbon (TOC) analysis provides a quick and efficient analytical process for cleaning validation in the pharmaceutical industry. When a single piece of equipment in a pharmaceutical manufacturing facility processes different active pharmaceutical ingredients (APIs), cross-contamination between products must be kept to an absolute minimum. Cleaning validation is the ove...

The compelling drivers for the pharmaceutical industry are minimizing the time between a drug’s discovery and its delivery to the marketplace, and maintaining high productivity in the manufacturing processes. During a product’s lifecycle many complex decisions must be made to achieve these goals. To better support the development and manufacturing processes at each stage, we have proposed a new...

Organic solvents are commonly used in the pharmaceutical industry as reaction media, in separation and purification of synthesis products and also for cleaning of equipment. This paper presents some aspects of organic solvents utilization in an active pharmaceutical ingredient and a drug product manufacturing process. As residual solvents are not desirable substances in a final product, differe...