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Biomedical subjects

C Hallett

Publications and source records attributed to C Hallett.

11 recordsLinked to original sources
PubMed1995

Assessing equivalence of inhaled drugs.

The move to disease management has led to an increase in the practice of drug or formulation substitution on the basis of equivalence. Well established guidelines are available for judging equivalence between oral, but not inhaled, formulations. This article describes the criteria by which equivalence can be assessed and concludes that although traditional issues such as adequate sample size are important, studies also need to be designed in such a way as to avoid the possibility of falsely concluding clinical equivalence.

Administration, Inhalation↗
PubMed1987

The effect of midazolam (Hypnovel) administration on antipyrine pharmacokinetics in humans.

1. Twelve healthy volunteers were given a standard regimen of oral midazolam (Hypnovel) (15 mg nightly) for 10 consecutive nights. 2. Antipyrine pharmacokinetics were studied immediately before midazolam administration was started, after the dosage schedule had been completed and one week after dosing had been discontinued. 3. No statistically significant changes were seen in the disposition of antipyrine as assessed by the plasma half-lives, areas under the curve and plasma clearances. Therefore, although previous studies have demonstrated that high doses of midazolam induced the drug-metabolising enzymes in laboratory animals, such effects are unlikely to occur in humans being treated with therapeutic doses.

Adult↗
PubMed1985

A multi-centre, double-blind parallel trial of bromazepam ('Lexotan') and lorazepam to compare the acute benefit-risk ratio in the treatment of patients with anxiety.

A double-blind, multi-centre study was carried out in general practice to compare the efficacy and tolerance of treatment with bromazepam and lorazepam in 671 patients with anxiety. Patients were treated at random with either bromazepam (3 to 9 mg per day) or lorazepam (1 to 3 mg per day) for periods up to 2 weeks. In the doctors' global assessment of response, significantly more patients improved on bromazepam (84%) compared with lorazepam (77%). Thirty-three percent of the bromazepam patients reported at least one unwanted event compared with 37% in the lorazepam group. The results are discussed in the context of improving the benefit-risk ratio.

Adult↗
PubMed1984

Bromazepam: acute benefit-risk assessment in general practice.

A study was carried out in general practice to assess the benefit-risk ratio of a single new drug, bromazepam, prior to marketing. Analysis of data supplied by 393 participating doctors on 3101 patients showed that bromazepam, in a dose range of 3 mg to 9 mg daily in divided doses, was effective as an anxiolytic in 79% of the patients and that the acute risk of treatment was predictable and low. It is concluded that the acute benefit-risk ratio is acceptable with respect to the class of drug and indication for which bromazepam is prescribed.

Adolescent↗
PubMed1983

A clinical pharmacological comparison of diclofensine (Ro 8-4650) with nomifensine and amitriptyline in normal human volunteers.

1 Ten healthy male volunteers participated in a double-blind placebo-controlled crossover comparison of the pharmacodynamic profiles of single oral doses of diclofensine 25 mg and 50 mg, nomifensine 75 mg and amitriptyline 50 mg. 2 Diclofensine did not influence salivary flow or consistently affect pupil diameter and had no significant effect on subjective measurements of sedation and mood. It had no effect on reaction time, or on critical flicker frequency. 3 By contrast, amitriptyline significantly reduced salivary flow, produced significant sedation and impairment of mood, prolonged reaction time, and appeared to decrease (but not significantly) critical flicker frequency. 4 Nomifensine significantly reduced (i.e. improved) reaction time, and inhibited salivary flow. 5 Diclofensine did not significantly influence heart rate, blood pressure, systolic time intervals or high speed electrocardiogram. 6 No significant treatment-related differences were observed in serum prolactin, cortisol or growth hormone levels.

Adolescent↗
PubMed1983

Flunitrazepam: acute benefit-risk assessment in general practice.

A methodology is described which is practical in assessing the benefit-risk ratio of a single new drug prior to marketing. Flunitrazepam at doses of 0.5 mg, 1.0 mg (and 2 mg) nocte in 2,435 patients is shown to be effective in 78% of patients and the acute risk, predictable and low, irrespective of age or dose. One may conclude that the acute benefit-risk ratio is acceptable with respect to the class of drug and indication for which flunitrazepam is prescribed.

Adult↗
PubMed1981

Plasma viscosity--a new appraisal of its use as an index of disease activity in rheumatoid arthritis.

The suitability of the plasma viscosity (PV) test has been examined in relation to the more commonly used erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) estimations as a diagnostic aid in 120 outpatients with rheumatoid arthritis (RA) and as an index of improvement during subsequent specific antirheumatic drug treatment (60 outpatients). Correlation data based on 7 clinical variables suggest that PV estimations are at least as reliable as ESR and CRP in terms of diagnosis and as indices of improvement. The methodological advantages offered by the PV test lend support to its application in RA.

Arthritis, Rheumatoid↗
PubMed1980

Discriminatory indices of response of patients with rheumatoid arthritis treated with D-penicillamine.

A long-term study is being undertaken to classify drugs used as specific agents in the treatment of rheumatoid arthritis in terms of their effects on biochemical and clinical characteristics of the disease. In particular is hoped to establish those indices which are most relevant to the response of RA to treatment. Fifteen patients were treated with D-penicillamine after an initial period of 2 weeks on aspirin alone, when the baseline investigations were made. The dose of penicillamine was increased gradually to a maximum of 500 mg a day over the period of 6 months, and changes in 8 clinical and 25 laboratory indices were measured on 8 separate occasions in the 6-month period. Marked clinical improvement took place, and this was mirrored by changes in a wide range of biochemical parametaers. ESR and C-reactive protein were shown to be the most suitable indices of disease improvement with penicillamine treatment.

Adult↗
PubMed1977

Increased sensitivity to nitrazepam in old age.

The effects of a single 10 mg oral dose of nitrazepam were compared with those of a placebo in healthy young and old people. Both the young and the elderly slept better on three successive nights after nitrazepam but they felt less awake at 12 and 36 hours (P less than 0-01). Elderly people made significantly more mistakes in a psychomotor test than did the young, despite similar plasma concentrations of nitrazepam and half lives in the two groups. This difference in response to psychomotor testing is probably explained by an increased sensitivity of the ageing brain to the action of nitrazepam.

Adult↗