Good science

A description of how large academic laboratories are administered, illustrating how different management styles can be successful, has appeared in the literature.114 There is great diversity in laboratory operations in large laboratories, but clearly contact between those who plan the projects, those who have high skills in project operations, and those who execute the more 

Standards and blanks are the usual controls used in analytical HPLC. Standards are usually interspersed with samples to demonstrate system performance over the course of a batch run. The successful run of standards before beginning analysis demonstrates that the system is suitable to use. In this way, no samples are run until the system is working well. Typically, standards are used to calculate column plate heights, capacity factors, and relative response factors. If day-to-day variability has been established by validation, the chromatographic system can be demonstrated to be within established control limits. One characteristic of good science is that samples 

The use of internal standards is somewhat controversial.115 There is agreement that an internal standard may be used as a correction for injection volume or to correct for pipetting errors. If an internal standard is included before sample hydrolysis or derivatization, it must be verified that the recovery of the internal standard peak is highly predictable. Ideally, the internal standard is unaffected by sample handling. Using an internal standard to correct for adsorptive or chemical losses is not generally approved, since the concentration of the standard may be altered by the conditions of sample preparation. An example of internal vs. external standards is given in Chapter 4. 

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To implement the Physiome Project, a lot of good science (Wolpert) and thinking (Dover) will be required. The tools that will ultimately define the success of the project are analytical models of biological processes that have predictive power - virtual cells, tissues, organs and systems. 

The GLP training should consist of two parts first, a classroom presentation of the materials described in Section 4 above, and second, a field training session where the principals of documentation of mixing, calibration, and applications can be demonstrated. Disposal, cleaning, and maintenance procedures should also be discussed and demonstrated. The classroom presentation should stress that the four key areas to successful implementation of GLPs are (1) Good Science, (2) Documentation,... 

The public and the ethical industry are best served by decisions based on good science, adherence to high standards, and independent, expert review... If the industry starts with high quality science, effective analyses, and honest, responsive presentations, its regulatory problems will be few."... 

Make it clear that the laboratory is devoted to good science. 

The need for adequate documentation of laboratory operations is established not only by good science but also by regulatory requirements [137],... 

This three-part philosophy of our responses — legal evaluations, policy critiques and technical evaluations based on the need for "good science" at all regulatory stages and presentation of constructive alternatives, led to other operating philosophies. 

There is a second set of standards of study conduct that are less well defined. These are generally accepted practice, and though not written down in regulation, are just as important as GLPs for studies to be accepted by the FDA and the scientific community. These standards, which are set by what is generally accepted as good science by the scientific community, include techniques, instruments utilized, and interpretation of results. Most of the chapters in this book will reflect these generally accepted practices in one form or another. 

Acceptance of these applications is contingent not only upon adherence to guidelines and good science, but also adherence to GLPs. 

While not officially required, the FDA does have the authority to request, on a case-by-case basis, specific tests it feels may be necessary to address a point of concern. A genetic toxicity test could be part of such a request. In general, therefore, companies deal with genetic toxicity (after screening ) on a case-by-case basis, dictated by good science. If more than a single administration is intended, common practice is to perform the tests prior to submitting an IND. 

On re-reading what is one of his longest works the author found the reason why it seems to have made little impact on his colleagues. It is that this type of meticulous critical interpretation, although didactically useful, and necessary for good science does make rather dull reading. 

Several presentations were made during the workshop on the general role of science in decision making— the elements of good science sources of scientific information the role of bridging institutions and approaches to improving communications between scientists and decisionmakers. Barriers to using science were also discussed. 

Scientists should also seek to strengthen their communications with government and other stakeholders. Not only will this assure that decisionmakers have access to good science but it will improve their prospects for financial support. 

But politics were not an obstacle to friendship at Stanford. Thank goodness, science was the main interest and we were all on the same page in that regard. None of us really knew what to make of the vast ocean of experimental findings. Nevertheless, we hoped we would live to see the day when the significance of our work would become clear. Such clarity, unfortunately, is one of those ever-receding horizons. 

Validation of analytical methods is important both from the standpoint of good science and to satisfy regulators of the reliability of results reported in dossiers. When approaching validation of any analytical method, one must always ensure that the method is fit for purpose. The amount of resource should be appropriate to the phase of development and the degree to which the process is defined and the methods finalised. 

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