BIOS 7431 - Statistical Issues in Drug Research and Development

Numerous statistical issues attendant to providing biostatistical support to drug research and clinical development programs are identified and discussed. Real examples are used to illustrate and solidify how to address the issues

Multi-Target Drugs: The Trend of Drug Research and Development

Summarizing the status of drugs in the market and examining the trend of drug research and development is important in drug discovery. In this study, we compared the drug targets and the market sales of the new molecular entities approved by the U.S. Food and Drug Administration from January 2000 to December 2009. Two networks, namely, the target–target and drug–drug networks, have been set up using the network analysis tools. The multi-target drugs have much more potential, as shown by the network visualization and the market trends. We discussed the possible reasons and proposed the rational strategies for drug research and development in the future

Incentives for orphan drug research and development in the United States

Background The Orphan Drug Act (1983) established several incentives to encourage the development of orphan drugs (ODs) to treat rare diseases and conditions. This study analyzed the characteristics of OD designations, approvals, sponsors, and evaluated the effective patent and market exclusivity life of orphan new molecular entities (NMEs) approved in the US between 1983 and 2007. Methods Primary data sources were the FDA Orange Book, the FDA Office of Orphan Drugs Development, and the US Patent and Trademark Office. Data included all orphan designations and approvals listed by the FDA and all NMEs approved by the FDA during the study period. Results The FDA listed 1,793 orphan designations and 322 approvals between 1983 and 2007. Cancer was the main group of diseases targeted for orphan approvals. Eighty-three companies concentrated 67.7% of the total orphan NMEs approvals. The average time from orphan designation to FDA approval was 4.0 ± 3.3 years (mean ± standard deviation). The average maximum effective patent and market exclusivity life was 11.7 ± 5.0 years for orphan NME. OD market exclusivity increased the average maximum effective patent and market exclusivity life of ODs by 0.8 years. Conclusion Public programs, federal regulations, and policies support orphan drugs R&D. Grants, research design support, FDA fee waivers, tax incentives, and orphan drug market exclusivity are the main incentives for orphan drug R&D. Although the 7-year orphan drug market exclusivity provision had a positive yet relatively modest overall effect on effective patent and market exclusivity life, economic incentives and public support mechanisms provide a platform for continued orphan drug development for a highly specialized market

Research and Prospect of Quality Development of Pharmaceutical Technology in Drug Research and Development

Pharmaceutical technology is an indispensable and important link in drug research and development, which plays a key role in drug research and development quality. In the background of science and technology development, pharmaceutical technology has been greatly developed, but also to promote the quality of drug research and development, to provide more guarantee for people’s health. In the new era, how to achieve pharmaceutical technology innovation, so as to further improve the quality of drug research and development, is an important research topic in the current related industries. This paper mainly revolves around quality of pharmaceutical technology development of a series of exploration, in the traditional drug development based on a better control of drug quality, the future of smart pharmaceutical green pharmaceutical development direction, aims to further enhance the pharmaceutical technology, promote the quality of research and development to promote the comprehensive, promote the steady development of the pharmaceutical industry as a whole

Cardioprotective effects of exogenous and endogenous hydrocortisone in the rabbit model of ischemia-reperfusion Efectos cardioprotectores de la hidrocortisona exógena y endógena en el modelo isquemia-reperfusión de conejo

Reducing the infarct size in acute myocardial infarction is one of the most important goals driving new drug research and development. During the last two decades, many clinical studies have found cardioprotective effects of corticosteroids, but their exact role in ischemic preconditioning remains questionable. The aim of the present study was to determine the protective effects of hydrocortisone sodium succinate on myocardial preconditioning in rabbit hearts. Twenty-four male New Zealand rabbits were divided randomly & equally in four groups: 1) control, 2) Infarct, 3) Ischemic preconditioning (IP) and 4) Hydrocortisone (HYD). The HYD group received 50mg/kg Hydrocortisone 45min before major ischemia. Serum levels of cardiac troponin-T(cTNT) and cortisole were measured before and after the protocols. Triphenyl-tetrazolium chloride staining was used to determine the infarcted area. In the present study, exogenous hydrocortisone decreased infarct size by 53 in comparison to the infarct group. Serum level of cortisole was increased in the IP and HYD groups, and was significant in the HYD group (p0.01). In conclusion, we showed that hydrocortisone has cardioprotective effects when injected before the onset of myocardial infarction. In addition, we have proposed for the first time that endogenous hydrocortisone may play a role in ischemic preconditioning phenomena

Market Structure and Drug Innovation

An explosion of knowledge and a growing array of tools and technologies have transformed modern drug R&D, while its cost has risen by a sizable amount. At the same time, the unchecked increase in health care and prescription drug spending has spawned cost containment policies that are restricting the demand for drugs in all major markets. This Perspective explores the interplay between technological advances and regulatory policies and their likely impact on the dynamics of the pharmaceutical industry. Advances in the life sciences have profoundly transformed the drug research and development (R&D) process. That transformation has come at a price, boosting the cost of developing a new molecular entity (NME) to 802 million by 2000. More expensive R&D, combined with an aging population and better diagnostic techniques, has swelled drug spending in the United States, which reached 141 billion in 2001. These increases have in turn induced a spate of cost containment measures that are affecting demand for pharmaceuticals in all major markets. This Perspective considers the impact of the interplay between technological advances and health care policy on the future dynamics of the pharmaceutical industry.Pharmaceutical Industry, R&D Productivity, Health Care Policy