Assay office

“ If it purports to be or is represented as a drug, the name of which is recognized in an official compendium, and its strength differs from, or its safety, efficacy, quality or purity falls below the standards set forth in such compendium, except that whenever tests or methods of assay as prescribed are, in the judgment of the Department, insufficient for the making of such determination, the Department shall promulgate regulations prescribing appropriate tests or methods of safety, efficacy, quality or purity shall be made. ”

“ The Bureau of Chemistry has been organized and put in charge of food investigation and inspection, and has attracted to it the chemical inquiries of the other administrative branches, such as sugar testing for the treasury department and ink testing for the post office department. The Bureau of Soils has been established to take up the examination in detail of the lands of the United States and its possessions, and report upon their character and crop-producing fitnesses. ”

“ In its Library-screening mode, Eve systematically tests each member from a large set of compounds against an assay in the standard brute-force way of conventional mass screening [5] . While simple to automate, brute-force mass screening is slow and wasteful of resources as every compound in the library is tested. It is also unintelligent, as it makes no use of what is learnt during screening. Eve starts the lead discovery process by mass-screening a subset of its library to find ‘hit’ compounds for the assay. ”

“ We are still of opinion that, when the importance of a general collection and of a laboratory of assay in constant activity is felt as it ought to be, the influence of the Royal Institution will not be exerted in vain. The plan, which the managers have limited to the present scale of their building and to the funds of their Institution, has obtained general approbation. ”

“ An accredited analytical laboratory should be used to conduct analysis of collected samples, and it is essential to consult with the analytical laboratory before sampling to ensure that the measurement methods available can meet the defined sampling needs. ”

“ Precipitation or reduction (or whatever it may be) is now made; the assistant filters the prepared samples, one at a time, whilst the assayer is engaged with the others. The same style of work is continued until the assays are completed. If one should be spoiled, it is better to allow it to stand over for assaying along with the next batch. If one filters slowly or is in any way less forward than the rest, it may lessen the accuracy of the other assays, owing to oxidation, &c., it should, therefore, be put on one side. ”

“ Hazard Identification And Dose-Response Assessments.—Beginning on the date of the enactment of the Improving Science in Chemical Assessments Act, any covered assessments carried out with respect to a chemical substance through the Integrated Risk Information System program of the Environmental Protection Agency as of the day before such date of enactment shall, in lieu of being carried out through such program, be carried out by the relevant program office of the Environmental Protection Agency, so long as the relevant program office determines there is a need for such an assessment. ”

“ The Board of Agriculture has two laboratories which are registered for the performance of experiments having for their object the detection and study of the diseases of animals. In other places experiments have been made on behalf of the Home Office, the War Office, the India Office, the Local Government Board, the Office of Works, the Board of Agriculture and Fisheries, and the Metropolitan Asylums Board. ”

“ However, it is also conservative, as the difficulties in physically creating structurally diverse libraries means that the probability of an individual compound being a novel structural hit probably decreases with the size of the library, which means that the savings are probably much greater for large libraries. Therefore, intelligent screening is more cost-effective with larger libraries, more valuable compounds and fast cycles of assay screening and testing—this is the standard regime for pharmaceutical screening, suggesting that adoption of intelligent screening is economically rational. ”

“ Again, what are to be defined as bureaus devoted entirely to scientific research? It is common knowledge that many in the Department of Agriculture conduct researches and investigations, that divisions of the War and Navy Departments do the like, and doubtless there are many other bureaus and sections in various departments of government where employees are set the task of solving problems all of which involve more or less of science. Shall the field of the scientist be distinguished from the art of a skilled mechanic? ”

“ Drug Testing Programs.
(a) The head of each Executive agency shall establish a program to test for the use of illegal drugs by employees in sensitive positions. The extent to which such employees are tested and the criteria for such testing shall be determined by the head of each agency, based upon the nature of the agency's mission and its employees' duties, the efficient use of agency resources, and the danger to the public health and safety or national security that could result from the failure of an employee adequately to discharge his or her position. ”

“ On the whole, it is usually possible to form a fairly definite estimate of the value of experimental data.
When one comes to the clinical evidence, an entirely different atmosphere obtains. When the Council demands evidence of the usefulness of a remedy, the manufacturers generally respond with every sign of enthusiasm. They may have ready a series of articles already published, or they instruct their agents to bring in letters from physicians. The last method seems to meet the most cordial response, judging from the deluge of letters and opinions that floods the Council. ”

“ With the employment of the first chemists and bacteriologists there arose a class of questions which I determined to settle once for all. There is a regrettable tendency among some scientific men to try to build barbed-wire fences around particular fields of research in which they happen to be interested, and to shoo every one else away.
At the outset I gave all employees clearly to understand that such an unscientific and ungenerous spirit would not be tolerated in the Bureau of Government Laboratories. The field which opened before us was enormous. ”

“ Article 100
⁠Drug regulatory departments may sample and test drug quality based on the needs of supervision and inspection. With regard to selective sampling and testing, samples shall be taken in accordance with the relevant regulations, and no fees shall be charged. Any sample taken for testing shall be purchased. Necessary expenses shall be listed and covered in accordance with the regulations of the State Council. ”

“ The Assay Department is strictly a technical and scientific branch of the service. It has been practically under one regime, for the last fifty years. There have been but three Chief Assayers in that time, the only removals being by death, the only appointments by promotion. Its workmen are all picked men, selected from other parts of the Mint for special fitness and good character. ”

“ If the manufacturer resists payment, the commissioner is required to publish the analysis in an official bulletin and also in one or more newspapers. The department is required to have sufficient chemists and assistants and the necessary equipment to enable it promptly to make a report of the chemical analyses of all samples sent by purchasers or consumers. It is authorized to collect and analyze fertilizer offered for sale in the state. Samples for analysis are required to be taken from at least 10 per cent. ”

“ There is nothing about the test that need make anybody hesitate in taking it, and it is safe to say that, when properly done, the information that it gives is more than worth the trouble, especially to those who have at any time been exposed, even remotely, to the risk of infection. But the test must be well done, by a large hospital or through a competent physician or specialist, and the results interpreted to the patient by the physician and not by the laboratory that does the test, or in the light of the patient's own half-knowledge of the matter. ”

“ When the Home Office allows a licensee to make a certain number of experiments, it means that he may experiment on that number of animals and no more. The Home Office, having heard what the experiments are to be, where they are to be made, on what kind of animals, and for what purpose, and having taken advice about them, allows him to make a fixed number, and adds any restrictions that it likes, e.g. that he must send in a preliminary report when he has made half that number. And one thing is certain, that one experiment = one animal, and that 10 experiments = 10 animals, and no more. ”

“ As the American Medical Association is national in its scope, the laboratory has held that it can do analytical work only when such work will be of general interest to physicians and of value both to the medical profession and the public. In view of this it has refrained from undertaking analyses which would benefit only the physician making the inquiry and possibly his patient. The laboratory further has not felt justified in undertaking work of merely local interest ”

“ To accomplish this goal, quality assurance personnel should work closely with laboratory personnel to quickly identify and eliminate trouble spots. It will not always be possible to isolate the source of error in the results of a blind sample. ”

“ Very frequently the results of costly law cases hang on the reports of expert food examiners; every care, therefore, must be taken to avoid error. This being the case, whenever possible, chemical tests should be carried out to confirm the results of microscopic examination. When both microscopist and chemist come to the same conclusion, there is not likely to be any mistake. There are tests which the microscope cannot perform, there are some, also, which are beyond the powers of the chemist and many which are very difficult for him. ”

“ No person shall, in the advertisement of any food, drug, cosmetic, device, or hazardous substance, make use of any reference to any laboratory report of analysis required to be furnished to the concerned department, unless such laboratory report is duly approved by such department. ”

“ In cases where an employer has an existing program of mandatory physical examinations for employees or applicants, an issue arises as to whether the addition of drug testing constitutes a substantial change in the employees' terms and conditions of employment. In general, we conclude that it does constitute such a change. When conjoined with discipline, up to and including discharge, for refusing to submit to the test or for testing positive, the addition of a drug test substantially changes the nature and fundamental purpose of the existing physical examination. ”

“ The Research Laboratories of The National Canners Association at Washington is undertaking the training of men in this analytical work for those companies that desire it. If the packer is close enough to a reputable analyst to get a report within a day or two he will find that such an arrangement is usually satisfactory, and he should rush his samples with all possible speed, and request the analyst to wire the report if the analysis is high. ”

“ In designing diagnostic-testing programs, some employers establish a set of basic tests that are to be administered to all employees, see generally M. Rothstein, Medical Screening of Workers 16-19 (1984) , regardless of whether there is cause to believe a particular employee will test positive. It is arguably within Conrail's range of discretion to alter its position on drug testing based on perceived changes in these variables. ”

“ In the case of all articles having a standard of purity fixed by any of the laws of the State, the certificate of the analyst should show the relation of the article in question to that standard.
5. Where standards of strength, purity or quality are not fixed by law, the Committee of Analysts shall present to the State Board of Health such standard as in their judgment should be fixed.
6. Each analyst should keep a record book, in which should be entered notes, as follows:—
(1) From whom the sample is received. ”

“ Human Tissue Samples.—On an annual basis, the Director of NIH shall submit to the Congress a report that describes how the National Institutes of Health and its agencies store and track human tissue samples. ”

“ The minimum data entered in the notebook should be sufficient to enable another chemist to derive the same results as the original worker, with no other source of information. In addition to this minimum data, any other facts appropriate and pertinent to the sample analysis are to be entered. A chemist's notebook is always subject to inspection by his colleagues, supervisors, or inspectors from outside the laboratory. ”

“ What is more significant than any variations in the reports is a strain of uniformity that runs through all alike. Not in one of them is there a disclosure of the individual data brought together by the Commission through the work of its investigators. Not in one is there the suggestion that the reasonable opportunity for a hearing conceded by the statute carries with it the opportunity to inspect 'every particle of evidence' collected by the Commission, and to examine and cross-examine the men who have collected it. ”

“ Given an unlimited quantity of a substance for testing purposes it is not always easy to determine its composition. With very small quantities, perhaps less than a tea-spoon full in all, the difficulties of the analyst are increased tenfold and without the assistance of the microscope his efforts would be unavailing, he deals in drops and every drop is precious. Sad to relate this form of testing, known to science as micro-chemical analysis, has been practised to a far greater extent on the continent than in this country. ”