Product development life cycle

Validation of a new or existing product involves the efforts of scientists at various stages of the product development life cycle. Scientific information... 

The GMP regulations apply to investigational new drug products produced for clinical trials in humans or animals, whereas those activities earlier in the product development life cycle such as basic research, discovery or preclinical experimentation are not subject to GMP requirements. 

Under the new paradigm for decision making, all decision makers will increasingly be forced to take into account the perspectives of the other players affected by their decisions. Prescribers will no longer consider just the clinical impact, but also the economic impact their decision will have on the payer, and the QOL impact the decision will have from the patient s perspective. The payer and patients will need to consider the impact of their decisions on the rest of the system. Successful drug developers now evaluate three-dimensional outcome data as early as possible in the product development life cycle. This information will also be useful to investors who are making decisions regarding the ultimate potential for success or failure of a newly discovered therapeutic product. 

Whereas case study 1 is a good example of work performed early in the product development life cycle, the next case study presented in this chapter is more representative of a study performed much later during the development stage (or even during process/product validation). From a DOE perspective, the only real difference between the two case studies is the number of factors being considered. As case... 

From R D to quality control, rheology measurements for each phase of the product development life cycle involve raw materials, premixes, solutions, dispersions, emulsions, and full formulations. Well-equipped laboratories with stress- and strain-controlled oscillatory/steady shear rheometers and viscometers can generally satisfy most characterization needs. When necessary, customized systems are designed to simulate specific user or process conditions. Rheology measurements are also coupled with optic, thermal, dielectric, and other analytical methods to further probe the internal microstucture of surfactant systems. New commercial and research developments are briefly discussed in the following sections. 

In general, the use of Bayesian network meta-analysis has broad applicability to evaluate AEs between related drugs. These methods can provide insight to prescribers and also assess cost-effectiveness. The direct probability statements that result from the Bayesian approach are helpful to decision makers evaluating a variety of medical products for a given therapeutic area/indication. Furthermore, the information obtained from the network meta-analysis can be utilized throughout the medical product development life cycle in simulations to design future clinical trials. 

There are many different descriptions of the product development life cycle available in literature. Each of them is valid and has its merit however, this validity and merit is explicitly related to, for example, the type of product, the type of organization, and the type of project. 

Figure 10.9 Safety influence versus product development life cycle. ...

Agile enterprise Companies that employ rapid customer/supplier partnering to achieve a short product development life cycle. Agility merges competencies in cost, quality, dependability, and flexibility. (Adapted from APICS Dictionary, 10th edition)... 

A general consensus that a deeper consumer involvement at an early stage in the product development life-cycle is beneficial to the success of food products development (Grunert et al., 2008 Stewart-Knox and Mitchell, 2003 Trijp et al, 2008 van Kleef et al, 2(X)5). 

Project management. This is managed by the project manager and, ideally, is divorced from any specific product development life cycles (PDLCs). 

Companies that employ rapid customer/supplier partnering to achieve a short product-development life cycle. Chapter 26... 

Usability has many potential benefits for development organizations, such as increased productivity and customer satisfaction. But even today there are quite few product development organizations reportedly having incorporated usability activities in their product development process. Bringing usability activities into the product development life cycle has been a challenge since the beginning of usability activities over fifty years ago [25]. One reason for this is that the benefits of better usability are... 

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