Chronotherapy involves the administration of medication in coordination with the body's circadian rhythms to maximise therapeutic effectiveness and minimise/avoid adverse effects. The aim of this study is to investigate the "time of administration" recommendations on chronotherapy for commonly-prescribed medicines in Australia. This study also aimed to explore the quality of information on the ...

New product development, which until relatively recently was a core activity within the pharmaceutical industry, is increasingly being outsourced (Howells et al., 2008). This is symptomatic of the transformation of product development towards a more decentralised, network-based and alliance-rich function. We have selected the pharmaceutical industry for this paper because it offers an excellent...

Carbon emissions are receiving greater scrutiny in many countries due to international forces to reduce anthropogenic global climate change. Carbon taxation is one of the most common carbon emission regulation policies, and companies must incorporate it into their production and pricing decisions. Activity-based costing (ABC) and the theory of constraints (TOC) have been applied to solve produc...

This paper does not present finished work but discusses a current problem faced by the EMEA in detecting when a new safety problem with a marketed pharmaceutical product is emerging. This detection is based on analysis of a very large database of spontaneous reports by healthcare professionals. The mixture of complexity but also known structure within the data appear to call for a combination o...

Laboratory Directors assume responsibility for the quality of data that is reported from their laboratories. A recent publication reminds us that the laboratory is likely to see contradictory data when comparing in-house interference data to information reported on the package insert (1). However, the quality of interference testing data provided by the manufacturer is seldom questioned, and, i...

the supply chain represents the critical link between the development of new product and the market in pharmaceutical industry. over the years, improvements made in supply chain operations have focused largely on ways to reduce cost and gain efficiencies in scale. in addition, powerful regulatory and market forces have provided new incentives for pharmaceutical firms to basically rethink the wa...

The FDA’s Quality by Design initiative and associated design space construct (ICH, 2009), have stimulated the use of quantitative methods, mathematical and statistical models, and designed experiments in the process of drug development and manufacture. For a given drug product, the design space may be interpreted as the constrained region of the manufacturing operating variable space within whi...

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Quality by Design (QbD) refers to a holistic approach towards drug development. QbD has become the answer to assist both industry and FDA to move towards a more scientific, risk based, holistic and proactive approach to pharmaceutical development. The concept promotes industry’s understanding of the product and manufacturing process starting with product development, basically building quality ...