Biomedical subjects

G Berner

Publications and source records attributed to G Berner.

At least 19 recordsLinked to original sources

PubMed2000

Prognostic and predictive implications of HER2 status for breast cancer patients.

Women diagnosed with breast cancer face many emotional and psychological challenges, which are often related to how they perceive their chances of survival. A number of factors are known to be indicators of breast cancer prognosis, including tumour type, size and grade, and lymph node status. These factors can be used alone or in combination to make management decisions based on a broad assessment of tumour aggression. However, identifying an independent marker of prognosis has proved more difficult. The human epidermal growth factor receptor-2 (HER2) is amplified/overexpressed in 25-30% of breast tumours. This event has been shown to be associated with poor prognosis in breast cancer patients. Initial observations indicated that median survival duration is reduced by at least 50% in patients who overexpress HER2 compared with those who do not overexpress the receptor. This finding has been supported by many subsequent studies and data are accumulating to indicate that the relationship holds for both node-negative and node-positive patients. This could be particularly important for identifying the 30% of node-negative patients who will progress despite therapy. HER2 status may also be able to predict the outcome of therapy. It appears likely that HER2 overexpression predicts for resistance to tamoxifen and other hormonal therapies. It is also possible that HER2-overexpressing patients may respond better to dose-intense anthracycline therapy and worse to cyclophosphamide/methotrexate/5-fluorouracil than non-overexpressing patients. Explaining these associations to patients may empower them to deal with the psychological effects of a diagnosis of breast cancer while providing hope for the future.

Journal Article↗

PubMed1992

[Pharmacokinetic aspects of a combination of metoclopramide and paracetamol. Results of a human kinetic study and consequences for migraine patients].

An open trial was carried out in eight healthy male and female volunteers to examine the bioavailability as well as the main kinetic parameters of Migränerton (metoclopramide and paracetamol; CAS 364-64-5 and CAS 103-90-2, resp). in comparison with reliable literature data. The results reported here clearly show that the absorption of both active ingredients from the fixed combination is complete and that therapeutically relevant plasma concentrations are achieved within 30 min. Bioavailability as well as tmax, t1/2, and time-lag are comparable with data resulting from reliable and internationally acknowledged kinetic studies. The fixed combination was shown to be kinetically compatible with regard to all parameters determined for metoclopramide and paracetamol.

Acetaminophen↗

PubMed1991

The importance of pharmacokinetic data on sulpiride: results of a bioequivalence study of two sulpiride 200 mg preparations following oral administration.

In a within-subject comparative trial in 16 healthy volunteers, the bioequivalence of two sulpiride 200 mg preparations was tested using a model-free method of calculation as well as assuming 2- and 3-compartment models. As to AUC act., AUC inf. and Cmax, the test preparation was shown to be significantly superior. Some other differences were found depending on which calculation method was used. The Cmax of the test preparation showed therapeutically relevant plasma concentrations of greater than 400 ng/ml, compared with about 300 ng/ml for the reference preparation. Based upon the raw data obtained, it was the aim of this study to gain further knowledge about other kinetic parameters on which only few data is available. T1/2 beta, clearance, volume of distribution and MRT were calculated using 2- and 3-compartment models. Comparisons with literature data were made and it resulted that a better description of the sulpiride kinetics was obtained when a 3-compartment model was used. Finally, the course of the plasma level was calculated by computer extrapolation assuming a thrice daily administration of sulpiride 200 mg. As a result, steady-state is reached after 3-4 days showing plasma concentrations around 650 ng (reference preparation) and 850 ng (test preparation).

Administration, Oral↗

PubMed1990

[Pharmacokinetics and bioequivalence of two ibuprofen formulations].

In an open controlled randomized cross-over study in 16 healthy male and female volunteers the bioavailability of ibuprofen (CAS 15687-27-1) sugar-coated tablets (Dolo-Dolgit) was tested versus film-coated tablets containing ibuprofen 600 mg. As it results from the AUC evaluation, the bioavailability of both preparations is very good and almost identical. The ibuprofen concentrations achieved after administration of the test preparation, however, are significantly higher (Cmax = 52.03 micrograms/ml) than those achieved after the reference preparation showing a Cmax of 40.32 micrograms/ml. The tmax of 1.0 h is also significantly shorter than after the reference preparation (tmax = 1.5 h). The t1/2 beta after both the test and the reference preparation is within the known range, i.e. 1.8 h and 1.4 h, respectively. Even in long-term treatment with high dosages, administered 3-4 times daily, there is no accumulation of the active ingredient. Concerning the therapeutic relevance, special attention is to be given to the different time-dependent drug concentrations in the central compartment and in the target compartment. Both the higher Cmax and the shorter tmax achieved following administration of the test preparation are of therapeutic relevance.

Adult↗

PubMed1989

[Concentrations of ibuprofen and the protein and pH value of synovial fluid and plasma following oral administration of ibuprofen in patients with arthritis].

Concentrations of Ibuprofen and Protein Concentration and pH-Value in Synovial Fluid and Plasma Following Oral Administration of Ibuprofen in Patients Suffering from Arthritis. In 16 patients suffering from arthritis of the knee the concentration of ibuprofen in the synovial fluid was examined in correlation with the synovial fluid volume, cell count, pH value and protein concentration. The mean ibuprofen concentration in plasma 4 h after oral administration of 400 mg ibuprofen amounted to 15.45 micrograms/ml, the concentration in the synovial fluid was 9.4 micrograms/ml. Due to the inflammatory nature of the effusions the protein concentration in the synovial fluid was evidently increased to an average of 4.46 g/dl and thus was about 65% of the mean plasma protein concentration of 6.88 g/dl. The ibuprofen in the synovial fluid showed a correlation to the protein concentration. On the other hand, there were no significant differences between the pH value in the plasma and in the synovial fluid. There was no tendency to an acid pH. Furthermore, there was no correlation between ibuprofen concentration and cell count. The tests showed that the "accumulation" of the nonsteroidal antiinflammatory drug in the synovial fluid is positively correlated with the high protein concentration but not with the pH value.

Administration, Oral↗

PubMed1989

Percutaneous ibuprofen therapy with Trauma-Dolgit gel: bioequivalence studies.

The plasma and tissue kinetics of ibuprofen after topical application of 5% Trauma-Dolgit gel were determined in two bioequivalence studies. In eight patients, high ibuprofen concentrations, largely within the therapeutic range, were found in subcutaneous tissue, tendon, muscles and joint capsule. In plasma, however, very low concentrations (decimal exponents below the therapeutically relevant plasma ibuprofen level even after repeated application) were found in nine volunteers. Based upon the comparison of oral and topical ibuprofen forms, the test preparation was found to be bioequivalent and, from a kinetic viewpoint, safe and effective.

Administration, Cutaneous↗

PubMed1989

Erythema chronicum migrans as the presenting manifestation of juvenile chronic myelocytic leukemia.

We describe the case of a 3-year-old boy who presented with typical clinical features of Lyme disease, including erythema chronicum migrans and arthritis. Over subsequent months, however, the clinical picture evolved into juvenile chronic myelocytic leukemia. To our knowledge, the combination of Lyme disease and juvenile chronic myelocytic leukemia has not been described. Dermatologic and other relevant clinical findings are presented, and the cause and effect relationship between these two rare entities is discussed.

Child, Preschool↗

PubMed1987

[The percutaneous kinetics of ibuprofen from a cream formulation].

The percutaneous penetration of an ibuprofen cream at 5% (Dolgit Creme) was tested in guinea pigs. Already 20 min after application of the cream on the shaved skin high ibuprofen concentrations of about 10 micrograms/g were found in the subcutaneous and in the muscular tissue. The plasma concentrations reached only one tenth of the values ascertained in the tissues. 2 h after application the concentrations in the tissue increased by 50%, whereas the increase of the plasma concentrations was more significant. The results confirm in agreement with kinetic studies in man that ibuprofen penetrates from the tested formulation directly and very quickly in deeper tissues. The deviation of the active ingredient over the systemic circulation is improbable.

Administration, Topical↗

PubMed1984

[Bioavailability of metoclopramide in a sustained-release preparation].

The aim of this study was to examine the pharmacokinetical behaviour of metoclopramide of Gastronetron retard capsules after a single administration to 8 healthy male volunteers. Determinations of the concentration of metoclopramide in the serum were made up to 24 h p.a. The calculation of the serum concentration curves was based on an open 2-compartment model. It has been proved that already 30 min after oral administration effective serum concentrations could be reached, which are maintained over about 24 h. An approximate value of 71% was obtained for the bioavailability of metoclopramide of Gastronerton retard capsules. The action achieved by the administration of 1 capsule Gastronerton retard per day can be considered equal to that of 3 single administrations of the conventional oral pharmaceutical form.

Administration, Oral↗

PubMed1983

[Pharmacologic-toxicologic study of an ibuprofen-containing creme].

The antiphlogistic action, the percutaneous penetrability as well as the systemic and local tolerance of cremes with a different ibuprofen content after epicutaneous administration were examined in the rat, the guinea-pig and the rabbit. The antiphlogistic action was dose-dependently assessed on the carrageenin-induced edema of the rat paw and on UV-erythema in the guinea pig. The cotton-pellet test carried out on the rat evidenced only modest efficacy. The percutaneous penetration of ibuprofen after single epicutaneous application was obtained through the assessment of the active principle in the tissues and in the serum. The tests carried out for ascertaining the systemic and cutaneous tolerance did not evidence even after 3 to 4 weeks treatment with the ibuprofen creme any signs of intolerance due to the substance. In the investigation of the mucosal tolerance, the instillation of ibuprofen creme into the conjunctival sac of the rabbit led to strong yet reversible intolerance reactions in the conjunctiva and in the eyelid. Bearing on the results obtained on the whole, ibuprofen creme at 5% can be envisaged for clinical examination for the treatment of circumscribed rheumatic and traumatic diseases.

Administration, Topical↗

PubMed1982

[Bioavailability of metoclopramide with special reference to relevant literature data].

An intraindividual comparative study of the pharmacokinetic properties of metoclopramide, the active principle of Gastronerton, and metoclopramide of a reference drug after one single administration was carried out on 6 male healthy volunteers. Gastronerton was available as ampoules, tablets, solution and capsules; the reference drug as ampoules, tablets and solution (all of them as commercial products). The concentrations of metoclopramide in the serum were determined until 24 h after administration. As one of the persons dropped out another volunteer was included. There were 6 cases for the intraindividual comparison of the parenteral/enteral form except for the comparison of the tablets/ampoules of the reference drug. An open 2-compartment model was taken as a basis for the calculation of the serum concentration curves and the pharmacokinetic parameters. With regard to the maximum serum concentrations, the preparations differed only insignificantly. The bioavailability results were as follows: metoclopramide of Gastronerton tablets 80.3%, metoclopramide of the tablets of the reference drug 57.6%, Gastronerton solution 76.7%, solution of the reference drug 49.7%. The bioavailability of metoclopramide of Gastronerton capsules was 54.8%. The half-life values were between 2.8 and 8.3 h with a mean value of 5 h.

Biological Availability↗

PubMed1979

[Comparative pharmacokinetics of paracetamol in humans following single oral and rectal administration (author's transl)].

The pharmacokinetic behaviour of N-acetyl-p-aminophenol (paracetamol) after single dose applications of 500 mg and 1000 mg dosages in the form of liquids, tablets and suppositories was compared. The estimation of the pharmacokinetic constants by a simultaneous curve fitting with a direct search procedure, based on an open two-compartment model, showed for the liquid as well as for the tablet formulation a good conformable and dosage proportional behaviour of the relative bioavailability. In opposite to the oral application, the suppositories had a significantly reduced invasion kinetics with a comparable elimination kinetics characterized by a lowering of Cmax and an increase of Tmax-values with comparable AUCs. The calculation of collapse-coefficients showed, with the exception of one suppository formulation, for all administrations a pharmacokinetic behaviour deviating from an open one-compartment model. The clinical consequences resulting from the pharmacokinetic behaviour of the different galenic formulations and routes of administrations are discussed.

Acetaminophen↗

PubMed1976