PubMed · 7390834
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T R Crites. 1980. Dose equivalent unit.. https://pubmed.ncbi.nlm.nih.gov/7390834/
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OBJECTIVE: To develop standards for polysomnography in Canada in order to assist in the uniform provision of diagnostic and therapeutic services related to sleep disorders. OPTIONS: Uniform testing versus no current Canadian standards. OUTCOMES: Uniform delivery of health care; reduction in number of repeat studies and their attendant costs. EVIDENCE: Availability of diagnostic laboratories and services, and survey responses (written and oral) from directors of sleep laboratories; the American Thoracic Society statement on indications and standards for cardiopulmonary sleep studies was used as a template. VALUES: Acceptable standards of practice were based on consensus opinion of the standards committees of the Canadian Sleep Society and the Canadian Thoracic Society. The committees comprised specialists in neurology, psychiatry, psychology, respirology and polysomnographic technology; family practitioners and otolaryngologists were also consulted. BENEFITS, HARMS, COSTS: Improved level of care and reduction in duplicate or unnecessary testing; establishment, with available resources, of diagnostic sleep laboratories by appropriately qualified physicians in areas where polysomnography is unavailable. RECOMMENDATIONS: Health care practitioners involved in the diagnosis and treatment of sleep disorders should possess a minimum amount of training (both clinical and research) in sleep disorders medicine. The variables recorded and findings entered in a patient's report must be relevant to the sleep disorder under investigation. The recording equipment must provide reliable, accurate and reproducible data and lend itself to appropriate calibration and quality-control procedures. Facilities for sleep studies must meet patient care safety standards, with provisions for emergency or resuscitative measures when necessary; all personnel must be trained in basic cardiopulmonary resuscitation. VALIDATION: No previous standards concerning polysomnography in Canada exist. The recommended standards were reviewed by all members of the Canadian Sleep Society and a revised document was approved by the Standards Committee of the Canadian Sleep Society and by the Standards and Executive committees of the Canadian Thoracic Society. SPONSORS: These standards are endorsed by the Canadian Sleep Society and the Canadian Thoracic Society. The cost of preparing this statement was borne by the individual members of the standards committees; no external funding was provided.
Validations of analytical methods are important for the generation of data for bioavailability, bioequivalence and pharmacokinetic studies. It is essential to use well defined and fully validated analytical methods to obtain reliable results that can be satisfactorily interpreted. This manuscript is intended to provide guiding principles for the evaluation of a method's overall performance. For this purpose, all of the variables of the method are considered, including sampling procedure, sample preparation, chromatographic separation, detection and data evaluation. The criteria considered are as follows: stability, selectivity, limits of quantification and of detection, accuracy, precision, linearity, recovery and ruggedness. Models used for analytical calibration curves are explained in term of validity and limitations, along with a presentation of the most common statistical considerations used to validate the model. Appropriate means of testing precision and accuracy, the most important factors in assessing method quality, are presented. Other issues, such as re-validation, cross-validation, partial sample volume, endogenous drugs and biological matrix of limited availability, are also discussed.
Quantitation by gas chromatography-atomic emission detection (GC-AED) is based on the intensity of the signal measured at a wavelength characteristic of an element, after atomisation by the plasma. This response depends only on the number of atoms of this element present in the molecule under investigation, and is independent of the structure of the molecule. This technique was used for the assay of propofol, and the estimation of its two metabolites, after calibration with standard solutions of pure propofol. The results were compared with those obtained by gas chromatography-mass spectrometry (GC-MS). Propofol was quantified with higher precision and accuracy by GC-AED than by GC-MS which exhibited larger residual values. Concentration assessment for two metabolites showed a better agreement with the theoretical value by GC-AED since the response depends only on the number of carbon atoms in each molecule.