Expert Commentary

Our first published report of the FDA data was accompanied by nine expert commentaries, some of them by researchers who had conducted clinical trials of antidepressant medication. Although there were vast differences in interpretation, this time there were no doubts about the accuracy of our analysis. Some commentators argued that our analysis had actually overestimated the real effect of antidepressants. Others argued that the clinical trials sponsored by the drug industry are flawed and that they may underestimate the actual benefit of antidepressants. But all... 

Brown WV (2007) Expert commentary the safety of fibrates in lipid-lowering therapy. Am J Cardiol 99 19C-21C. 

Part 1 consists of four chapters that give a crash course on statistics in drug development by presenting four different perspectives of the matter historical, methodological, technical and professional. The least authoritative of these is the first. Chapter 2, which gives the historical view and where I have had to rely on secondary sources via the expert commentaries of others (with the exception of the history of the t-test, (Senn and Richardson, 1994) and Fisher s involvement in trials in humans (Senn, 2006), where I have undertaken some original researches myself). Nevertheless, if one does not consider the history of a subject, however crudely, one is all too vulnerable to the myth of present perfect and I felt that it was important to cover history. Consideration of past imperfect helps to introduce a sense of proportion. 

Kenneth Cole, Devon Byrd, Amanda Dion-Schultz, Ben Hagar, Rick Jaffe, Christophe McCray, Jeff Owens, Christian Whitchurch, and Lloyd Whitman, who served as focus group leaders at the workshop and provided expert commentary... 

Putz, M. V. (2007a). Can quantum-mechanical description of chemical bond be considered complete In Kaisas, M. P. (Ed.) Quantum Chemistry Research Trends, Nova Science Publishers Inc., New York, Expert Commentary, pp. 3-5. 

Evidence-Based Medicine. Evidence-Based Medicine [45] consists of summarized abstracts of articles on family medicine, internal medicine, general surgery, pediatrics, obstetrics, gynecology, psychiatry, and anesthesiology with commentary by clinical experts. More than 50 peer-reviewed medical journals are abstracted. Also included are key selections from ACP Journal Club. Evidence-Based Medicine is commercially available however, its distribution is restricted and does not include North, Central, or South America. 

In completing Phil s book we have retained the set of examples and explanations, and occasional commentary, as he had intended it. It has, however, been some time since a book on ESR for the non-expert has appeared. We have therefore supplemented his original manuscript in two ways. At the end of Chapter 1 is added an up-to-date list of texts and monographs on ESR which should serve the interested reader as a source of additional treatments of the subject. Secondly, in Appendix 2 we have referenced and given brief descriptions of some advanced ESR methods that have been developed in recent years and applied in various fields, including biochemistry. The modern ESR spec-troscopist is now as likely to need an understanding of these techniques as of the classic X-band methods described here. We hope that this book will provide a basis for study of the newer methods. 

The control of food additives has been much discussed in newspapers and other parts of the media and yet, rather surprisingly, there have been few scientific books about additives. There have been detailed reports of the work of expert committees such as the Joint FAO/WHO Expert Committee on Food Additives (e.g. WHO, 2000) and informative commentaries on individual additives and legislative controls, notably those in the European Union (EU) (e.g. Leatherhead Food Research Association, 2000). There have also been articles on work to harmonise worldwide control of additives (Keefe et al., 2000). 

The first edition1 of this book was published approximately 13 years ago. Its primary objective was to present an overview and a "roadmap" of the process of new drug discovery and development, particularly oriented to individuals or companies entering the pharmaceutical field. It was written by one of the authors (Smith), with no contributors, and drawn on Smith s experiences in the industry and field over the course of nearly 40 years. In the second edition, the scope of the first book has been expanded and technical details in the form of hard data have been included. In addition to the editors own commentary and contributions, the major part of the book is the result of contributions of experts in the industry. New chapters on risk assessment, international harmonization of drug development and regulation, dietary supplements, patent law, and entrepreneurial startup of a new pharmaceutical company have been added. Some of the important, basic operational aspects of drug discovery and development (e.g., organizational matters, staff requirements, pilot plant operations, etc.) are not repeated in this book but can be found in the first edition. 

For a fiftieth anniversary commemoration of the paper s publication, the International Journal of Epidemiology reprinted the original 1954 paper and invited commentary from several experts, including Sir Richard Doll. Doll wrote ... 

The trial proceedings did not center upon the actual contents of my expert report, but on Remer s political commentary and my (alleged) political views. This was despite the fact that prosecutions for dissenting political views are forbidden according to the German constitution (cf. article 3.3. of the German Basic law). They have a strong tendency to turn into show-trials, and this is exactly what happened in this case. 

A more complete analysis of the prosecution against Rudolf will be left to other works. Rudolf was accused not only because of Remer s political commentary, which was falsely attributed to Rudolf, but also because of the purely technical conclusions in his Report.663 In the principal hearing Presiding Judge Dr. Dietmar Mayer stated that the competence of the court did not extend to the evaluation of the scientific validity of the expert report. Because of this, the contents of the expert report were not addressed in the proceeding, but only the question whether the defendant was responsible for Remer s commentary. 

In its decision, the court made no secret of the fact that it held revisionist thinking itself to be reprehensible and punishable by increasing the severity of the sentence.664 However, the sentence against Rudolf to 14 months prison without probation was based on the false contention that Rudolf had at least knowingly contributed to the political commentary contained in Remer s version of his expert report. The court justified its sentence with a tiresomely assembled chain of proofs amounting to 240 pages which in decisive points departed from the actual evidence and which completely ignored the contradictory evidence on the main point of the defense. 

Hakkinen PJ (1993) Commentary about intuitive toxicology Expert and lay judgments of chemical risks. Comments on Toxicology 4 505-509. 

Validation is defined as the formal determination of the suitabUity of a given analytical method for an intended apphcation, achieving this by determining the rehabUity of results obtained [144], The following extract from the paper Vahdation of Analytical Results in Pharmaceutical Analysis by Renger et al. serves as the basis of this Chapter. Briefly, based on differences in requirements and even in definitions of terms used in the United States and Europe, experts from these coimtries and from Japan, who have been attending meetings of the International Conference for Harmonization (ICH 1-1CH 3) since 1993, have prepared a scheme of imiform requirements for the vahdation of analytical results [145]. The framework of the present book would be exceeded if all the details and commentaries were discussed here. The interested reader is therefore referred to the hterature [144]. 

DEREK DEREK (Deductive Estimation of Risk from Existing Knowledge). An expert system is based on rules. It identifies the so-called toxicophores fragments of the molecule associated with the corresponding activity) and provides the related commentary for them and references to the available information http //www.lhasalimited.org/... 

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