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Biomedical subjects

D M Hailey

Publications and source records attributed to D M Hailey.

At least 37 records · Page 2Linked to original sources

Health technology assessment: an Australian perspective.

Like many other countries, Australia has placed increasing emphasis on the assessment of medical technologies over the past decade. This emphasis is shaped in part by financial constraints, and in part by the organization of the health care system and its dominance by publicly-funded hospitals. Two committees, the Superspecialty Services Subcommittee of the Australian Health Ministers' Advisory Council, and the National Health Technology Advisory Panel have been particularly influential in developing guidelines for technology assessment. These guidelines emphasize not only the accumulation of primary data during the implementation of a new technology, but also a follow-up process for on-going evaluation of the contributions of a particular technology to clinical care. Presently the two committees are being merged into one agency named the Australian Health Technology Advisory Committee. This agency will be given enhanced authority to guide the diffusion and utilization of new technologies into the delivery process for health care.

Australia↗

Health care technology in Australia and New Zealand: contrasts and cooperation.

Australia and New Zealand are neighbouring countries with similarities due to their settlement by Europeans, but with major differences in their economies, populations, geography and political systems. These differences have led to contrasting approaches to the introduction and control of health care technologies. New Zealand has historically had greater success in limiting the use of health technologies which have often been adopted more widely and rapidly in Australia. Recent initiatives in health technology assessment have involved participation by both countries, giving the potential for a joint approach to policy formulation on use of some medical devices and procedures.

Australia↗

Developments in near-patient testing.

Important technologies for near-patient testing include 'desk-top' analysers, kits and systems for continuous monitoring, with the possibility of advances through approaches to genetic testing. Near-patient testing is now used in physicians' office, hospital ward, home care and population screening applications. Analytical performance achieved by operators in these settings may frequently cause concern and has led to increased support for accreditation and educational measures. While near-patient testing has much potential to contribute to health care, hard evidence of benefit is sparse, and the costs of such testing to health care systems may be substantial. The place of this technology still requires critical evaluation, in the context of system performance and relevance to health care.

Cost-Benefit Analysis↗

Assessment of physicians' office pathology testing: organisational considerations.

In this paper we consider organizational and design aspects of an assessment of physicians' office pathology testing, and discuss difficulties in measuring the level of performance and effectiveness of such diagnostic services. A major consideration is the trade-off between compliance with a well-defined protocol, and use of the technology in a way which resembles normal operating practice.

Australia↗

A comparative study of BP and USP rotating basket dissolution apparatus.

The difference between BP and USP rotating basket dissolution apparatus was investigated by applying both methods to a range of commercial formulations and the NCDA Performance Standard II. No significant differences were obtained between the two sets of apparatus for the commercial tablets. However appreciable difference was observed with the NCDA calibrator.

Pharmacopoeias as Topic↗

Tensile strength requirements for sutures.

The official requirements for sutures in Australia are those of British Pharmacopoeia (B.P.). The results of a survey conducted by this Laboratory indicate that the B.P. test and specifications for knot pull strength are no longer appropriate for sutures currently available in this country. It is suggested that tensile strength measurements on sutures should be carried out, without prior soaking, using the load cell type of constant rate of extension apparatus rather than the pendulum type tester specified in the B.P. Use of a simple knot is suitable for testing synthetic sutures, but the surgeon's knot is preferred for catgut. All products tested easily met both the B.P. and the United States Pharmacopeia (U.S.P.) requirements for tensile strength.

Australia↗

Analysis of haloperidol tablets by high-performance liquid chromatography--an inter-laboratory study.

A high-performance liquid-chromatographic (HPLC) method for the determination of haloperidol in tablets was developed and evaluated by an inter-laboratory study. The spectrophotometric method of the British Pharmacopoeia 1973 was evaluated concurrently, and the accuracy and precision of the methods were compared. Two samples of a commercially available haloperidol tablet formulation were analysed by thirteen laboratories with satisfactory results for column performance and precision of assay. The total error standard deviations, SD, for the HPLC method and the spectrophotometric method were 3.92 and 2.58%, respectively. The HPLC method is considered suitable for official testing purposes.

Chromatography, High Pressure Liquid↗

Tests for foreign particles in metered-dose aerosols.

A simple method for the determination of foreign particular matter in metered-dose aerosols (MDA's) has been developed. The method compares favourably with a procedure currently used in pharmaceutical industry and has the advantage of providing information on container to container variation. A linear relationship between log particle count and particle size was found for a number of MDA's, although there was considerable product-to-product variation. On the basis of the results obtained in this study, commercially available MDS's would in general comply with a limit for foreign particles greater than 100 micrometers of not more than 150 particles per container with the sum of the mean count and twice the standard deviation not more than 200.

Aerosols↗

Specification of limits for particulate contamination in pharmaceutical dosage forms.

Limits for the control of particulate contamination in large volume parenteral solutions and metered-dose aerosols are discussed. It is suggested that is would be desirable to use limits based on measurement of both mean and the standard deviation of the particle counts obtained for each of the containers tested. Use of the statistic ST, assuming a target value of zero, is considered to be an appropriate means of measuring the container to container variation in particulate contamination.

Aerosols↗

Absorption of quinidine and dihydroquinidine in humans.

Quinidine and dihydroquinidine were administered as the sulphates in an oral solution to seven healthy volunteers. In all subjects, dihydroquinidine was absorbed to a lesser extent than quinidine. On the basis of comparative AUC pu to 6 h after administration, dihydroquinidine was 73% as available as quinidine. Rates of elimination of the compounds were similar. No correlation could be found between saliva and plasma levels for either compound. Limits for content of dihydroquinidine in commercial quinidine preparations seem essential to ensure adequate bioavailability.

Adult↗

Uniformity of content requirements for tablets and capsules.

Present pharmacopoeial requirements for uniformity of content of tablets and capsules are based on tests by attributes. A test for uniformity of content based on the root mean square deviation about target (ST) is more reliable than the pharmacopoeial tests and has the added convenience of using a single statistic to control both the mean content and the variation about the mean. Implications of the use of the statistic ST in uniformity requirements are discussed.

Capsules↗

High performance liquid chromatographic analysis of hydrocortisone acetate ointments: interlaboratory study.

An interlaboratory was carried out on a high performance liquid chromatographic method for determining hydrocortisone acetate in ointments. The method represents an alternative to the colorimetric procedure of the British Pharmacopoeia. Two samples of a commercially available hydrocortisone acetate ointment were analyzed by 14 laboratories. Column performance and precision of the assay were satisfactory. The total error standard deviation for the method was 3.69%.

Chromatography, High Pressure Liquid↗

Analysis of diethylstilbestrol and its impurities in tablets using reversed-phase high-performance liquid chromatography.

A high-performance liquid chromatographic (HPLC) method is described which is capable of resolving cis- and trans-diethylstilbestrol (DES), DES mono- and dimethyl ethers and 4,4'-dihydroxystilbene. The mobile phase and internal standard used stabilise the cis-trans DES isomer ratio, and the method is capable of quantitating both isomers in dosage forms without derivatisation. Recovery of DES from tablets is quantitative. Results of tablet analyses using this method are compared with those obtained with the official spectrophotometric procedure.

Chromatography, High Pressure Liquid↗

Plasma concentrations of medazepam and its metabolites after oral administration.

The plasma concentrations of medazepam and its metabolites, diazepam and desmethyldiazepam, were determined in volunteer subjects following the oral administration of medazepam 10 mg. The results indicated that medazepam was absorbed rapidly, that low concentrations of metabolites were present during the 1st h, and that the build-up in the circulation of the major metabolite, desmethyldiazepam, was prolonged and variable. As many of the clinical effects and possible adverse reactions of medazepam appear to be associated with the presence of this major metabolite, the metabolic and pharmacokinetic characteristics of the drug should be considered when using medazepam as an anxiolytic before dentistry or surgery.

Administration, Oral↗