Innovation clinical development

Despite an intensive research effort over the past two decades involving many innovative approaches in the global academic community and by the pharmaceutical industry, the latter representing an aggregate investment in excess of 2.5 billion, the only new opioid-based pain medications either in clinical development or on the market are alternative dosage forms of the classical opioids, morphine, loperamide, and fentanyl, or compounds such as tramadol. ... 

Given the abundance of water-insoluble or poorly water-soluble drugs as well as drugs exhibiting other development challenges such as metabolic and enzymatic instability, the pharmaceutical industry continues to seek solutions to overcome these limitations to develop innovative, clinically safe, and patient-friendly products. As said earlier, MR delivery products offer tremendous advantages with respect to therapeutic indices, pharmacoeconomics, and patient compliance. In addition,... 

Innovation and Development Unit, Division of Clinical Pharmacology, Service of Biomedicine, University Hospital Center and University of Lausanne, Lausanne School of Pharmaceutical Sciences, University of Geneva and Lausanne, Geneva, Switzerland... 

In this chapter, we hope to show how innovation was a key driver in discovering and developing the commercial synthesis of the complex API BMS-663068 (1), a potential first-in-class HIV attachment inhibitor prodrug, currently in clinical development (Figure 1). 

Geiger MJ, Mehta C, Turner JR et al (2015) Clinical development approaches and statistical methodologies to prospectively assess the cardiovascular risk of new antidiabetic therapies for type 2 diabetes. Ther Innov Regul Sci 49 50-64... 

With the increased acceptance of the Internet and the huge innovations in web development tools, web-based data collection and management systems have become the choice of many CROs because of their capability for collecting clinical trial data in real time and disseminating critical clinical trial information to the participating sites and various oversight committees [27]. 

The development of sensitive and inexpensive immunoassays for low molecular weight pesticides has been an important trend in environmental and analytical sciences during the past two decades. 0.27-29 jq design an immunoassay for a pesticide, one can rely on the immunoassay literature for agrochemicals, " but many of the innovations in clinical immunoanalysis are also directly applicable to environmental analysis. - Conversely, the exquisite sensitivity required and difficult matrices present for many environmental immunoassay applications have forced the development of technologies that are also useful in clinical immunoassay applications. In the following discussion we will describe widely accepted procedures for the development of pesticide immunoassays. 

For generic bioequivalence the generic manufacturer would be expected to use the same chiral material as the innovator (most probably a racemic mixture or pure active isomer, though it is possible that in some rare instances the innovator might have discovered a valid reason for using some mixture of R and S other than 50/50). Thus, as with development bioequivalency, it would not normally seem necessary to use stereoselective assays for the separate determination of R and S isomers. However, one can conceive of possible situations where clinically significant differences in R-to-S ratios could be caused by even relatively small differences in absorption rate [6,7]. 

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