Clinical development discipline

If not already available, a bioanalytical method needs to be defined and characterized for the quantification of the candidate in physiologic fluids. This method can then support experiments in each of the other scientific disciplines involved in assessing the developability of the lead candidate and, after appropriate validation, the preclinical, nonclinical, and clinical development of the drug candi-... 

Regulatory affairs are so fundamental to precli-nical and clinical development that it deserves a section of this book to itself. However, this is a purely artificial distinction which must not be allowed to obscure the crucial, intimate and interactive relationship between regulation and the other disciplines that are described in this section. 

If not already available, a bioanalytical chemistry method needs to be defined and characterized for the quantification of the lead in physiological fluids. This assay can then support experiments in some of the other scientific disciplines involved in assessing the developability of the lead and, after appropriate validation, the preclinical, nonclinical, and clinical development of a selected drug candidate. For preliminary studies, a bioanalytical chemistry method should be characterized to demonstrate the range of reliable results, the lower and upper limits of quantification, specificity, accuracy, and precision. In addition, evaluations on the matrix to be used (blood, plasma, serum) should be conducted and the stability of the lead in each matrix should be determined. 

Second, the overall emphasis here is clinical development, how this is done, and what preclinical information is needed in order to carry it out. Necessarily, we have here had to be general, and these chapters are mostly written to describe, and assist with, typical development issues. However, for some disciplines, this is impossible for example, there is little preclinical pharmacology in this section, since this discipline is really product-specific. In contrast, the general principles of toxicology (for example), and what the pharmaceutical physician needs to know about toxicology before starting any clinical trial, may be usefully stated in the general case. 

Fourth, the chapters on Phase I clinical trials and pharmacoeconomic research have been written by experts in these fields. These are very rapidly-developing disciplines. The typical pharmaceutical physician has usually paid little attention to these aspects of clinical development, but it is our belief that these will dictate his/her clinical development plans to an ever-increasing degree in the future. Phase I studies can shorten overall clinical development time, and the pharmacoeconomic leveraging of (especially) Phase III and Phase IV studies (with preparatory Phase II work) are now essential in the modern competitive environment. 

The integration of the activities described in these chapters is essential to good clinical development. Some cross-referencing and overlap between these chapters is deliberately included to emphasize such integration. Pharmaceutical physicians, specialized though they may be in one discipline or another, are well-advised to keep an observant eye on the interactions between their own and other company departments. Experience is probably the best teacher of integration. But we hope these chapters convey some idea. 

Our interest in the discipline of Statistics is a pragmatic one since it provides the best way currently available to conduct clinical development programs (Turner 2010). 

Another approach is the use of facsimile (fax) transmission to a dedicated computer equipped with software such Teleform software that can be customized to fit the needs of the clinical trial. Scannable forms are designed with specialized software and distributed to the participating sites to complete. SCs are equipped with fax machines to fax the completed forms to the central location. Advantages of this technology include the speed at which forms can be sent to a coordinating center and the fact that fax communications are very much standardized. Its drawbacks include the discipline required in form development and transmission. 

Analysis of biological data has now become far more complex, and there is a drive to develop software to allow disparate data sets, such as sequence, literature, clinical data and expression analyses, to all be accessible and interlinked. This allows movement between information systems and provides more complex meta-ana-lyses of these data sets, allowing a holistic view of biological research, in place of the current fragmented view we have available to us. This will ultimately lead to the blurring of boundaries between different disciplines, such as the areas of che-... 

Taxometrics was developed by clinical psychologists to study the taxonomy, of psychological disorders. Many other disciplines, including medicine, biology, and economics, have been concerned with taxonomic questions. Research in different disciplines takes place under different conditions The context of taxonomic questions varies, as well as the questions them-... 

Combining two different scientific disciplines morphology and immunochemistry immunohistochemistry has developed as an important instrument in research and clinical pathology. A basic understanding of underlying principles and potential problems is unavoidable if you want to be successful in your use of immunohistochemistry, as well as in getting your papers published and your research grants funded. 

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