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9 results on '"BETHKE, Th."'

1. Results of a survey on applied quality standards in non-interventional studies among the members of the German Association of Research-based Pharmaceutical Companies

Author

Hahn, M, Ruppert, T, Bethke, TH, and Hundt, F

Subjects
Qualitätssicherung, non-interventional studies, nicht-interventionelle Studien, Drug Industry, Quality Assurance, Health Care, Epidemiology, Data Collection, lcsh:R, lcsh:Medicine, quality assurance, 610 Medical sciences, Medicine, Anwendungsbeobachtungen, Article, Epidemiologic Studies, ddc: 610, Germany, qualitätssichernde Maßnahmen, Practice Guidelines as Topic, Guideline Adherence, quality-assurance measures, observational studies
Abstract

After the regulatory approval has been obtained, epidemiological studies are acknowledged scientific medical research methods for a new drug which provide additional knowledge about routine application of the drug in clinical daily routine. These studies are performed according to the recommendations of both international and national expert associations, the recommendations of the higher federal authorities in Germany and according to the recommendations of the associations of the pharmaceutical industry. Two surveys among the member companies of the Association of Research-based Pharmaceutical Companies investigated the status of the implementation of the recommendations in the years 2008 and 2010 and compared the results with each other. It could be shown that these recommendations were implemented successfully and were fully adhered to during the conduct of non-interventional studies in Germany. The recommendations define a quality standard which justifies a high level of confidence in the validity of the data collected and the results from these investigations., GMS German Medical Science; 8:Doc29; ISSN 1612-3174

Published
2010

2. Dose linearity and steady state pharmacokinetics of the new antiparkinson agent budipine after oral administration

Author

Heinze H, Bethke Th, Merz M, Zech K, Hauschke D, Seiberling M, and W. Wurst

Subjects
Adult, Male, Metabolic Clearance Rate, Metabolite, Cmax, Administration, Oral, Budipine, Pharmacology, Intestinal absorption, Antiparkinson Agents, chemistry.chemical_compound, Piperidines, Pharmacokinetics, Oral administration, Humans, Medicine, Pharmacology (medical), Cross-Over Studies, Dose-Response Relationship, Drug, business.industry, Half-life, Crossover study, Intestinal Absorption, chemistry, Area Under Curve, business, Half-Life, medicine.drug
Abstract

The dose-dependency of budipine pharmacokinetic characteristics was studied. Eighteen healthy male subjects were given 10, 20 and 30 mg oral single doses according to a randomized, open, 3-period crossover design. Additionally, the steady state conditions were investigated after repeated intake of 10 mg t.i.d for 10 days and compared to the 10 mg single dose. The area under the concentration vs time curve (AUC) and the maximum serum concentration (Cmax) showed a linear increase in line with ascending doses of orally given budipine. Time to maximum serum concentration (tmax) and terminal half-life (t1/2) were independent of the administered dose. As compared to the 10 mg single dose pharmacokinetics, the repeated oral administration of budipine 10 mg t.i.d. resulted in an increase in AUC of 11% and 93% for budipine and its metabolite p-OH-budipine, respectively. In clinical practice, a predictable response in proportion to the dose is to be expected.

Published
2009
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8. High Selectivity for Inhibition of Phosphodiesterase III and Positive Inotropic Effects of MCI154 in Guinea Pig Myocardium

Author

Bethke, Th., Meyer, W., Schmitz, W., Scholz, H., Wenzlaff, H., Armah, B. I., Brückner, R., and Raap, A.

Abstract

MCI-154 (0.3–100 μM) exerted a concentration-dependent positive inotropic effect in isolated guinea pig papillary muscles (EC500.8 μM). The efficacy of MCI-154 (253 of predrug value) was 1.7-fold higher than that of saterinone but comparable to that of milrinone. Carbachol markedly reduced the increase in force of contraction (FOC) of MCI-154. In intact contracting papillary muscles, the positive inotropic effect was accompanied by an increase in cyclicAMP content to 0.78 ± 0.09 pmol/ mg wet weight (n = 10), corresponding to 150 of the basal value (0.51 ± 0.05 pmol/mg wet weight, n = 21) in the presence of submaximal cyclicAMP phosphodiesterase (PDE) isoenzyme III inhibiting concentrations of MCI-154 (30 μM). MCI-154 (1–1,000 μM) concentration-dependently inhibited the activity of PDE III from homogenates of guinea pig myocardium. The IC50was 3.8 μM. PDE I, II, and IV were not significantly affected up to 100 μM (PDE I and IV) and up to 1,000 μM (PDE II). In comparison, milrinone and saterinone were PDE III/ IV-selective PDE inhibitors. Rolipram inhibited PDE IV only. IBMX and theophylline were nonselective PDE inhibitors. MCI-154 had only a marginal positive chronotropic effect. The frequency of spontaneously beating right auricles from guinea pig heart was increased by 8.7 at most (n = 5). MCI-154 increased Ca2+sensitivity in chemically skinned porcine ventricular muscle fibers. FOC was maximally enhanced to 129.3 of control value by MCI-154 (100 μM). The positive inotropic effect of MCI-154 is probably due mainly to inhibition of PDE III. In contrast to the PDE III/IV-selective PDE inhibitors milrione and saterinone, MCI-154 inhibited PDE III only. The increase in Ca2+sensitivity of the contractile proteins by MCI-154 may contribute to the positive inotropic effect.

Published
1993

9. Dose linearity and steady state pharmacokinetics of the new antiparkinson agent budipine after oral administration.

Author

Bethke TH, Merz M, Zech K, Seiberling M, Hauschke D, Heinze H, and Wurst W

Subjects
Administration, Oral, Adult, Antiparkinson Agents administration & dosage, Area Under Curve, Cross-Over Studies, Dose-Response Relationship, Drug, Half-Life, Humans, Intestinal Absorption, Male, Metabolic Clearance Rate, Piperidines administration & dosage, Antiparkinson Agents pharmacokinetics, Piperidines pharmacokinetics
Abstract

The dose-dependency of budipine pharmacokinetic characteristics was studied. Eighteen healthy male subjects were given 10, 20 and 30 mg oral single doses according to a randomized, open, 3-period crossover design. Additionally, the steady state conditions were investigated after repeated intake of 10 mg t.i.d for 10 days and compared to the 10 mg single dose. The area under the concentration vs time curve (AUC) and the maximum serum concentration (Cmax) showed a linear increase in line with ascending doses of orally given budipine. Time to maximum serum concentration (tmax) and terminal half-life (t1/2) were independent of the administered dose. As compared to the 10 mg single dose pharmacokinetics, the repeated oral administration of budipine 10 mg t.i.d. resulted in an increase in AUC of 11% and 93% for budipine and its metabolite p-OH-budipine, respectively. In clinical practice, a predictable response in proportion to the dose is to be expected.

Published
2001

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