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Biomedical subjects

A Káldor

Publications and source records attributed to A Káldor.

At least 19 recordsLinked to original sources

Pantothenic acid, acute ethanol consumption and sulphadimidine acetylation.

The effect of pantothenic acid and acute ethanol loading on the genetically determined N-acetyltransferase activity has been studied using sulphadimidine as a test substance. The administration of 1100 mg pantothenic acid daily (600 mg orally, 500 mg iv) for seven days did not significantly alter sulphadimidine kinetics in the primarily elderly 21 subjects we investigated. Acute ethanol loading (0.73 g/kg pure alcohol at start and 0.11 g/kg pure alcohol hourly for 8 hours afterwards, stock solution: 20% v/v ethanol in fruit juice) did not change sulphadimidine acetylation in 10 healthy male volunteers. It is concluded that despite theoretical assumptions exogenous factors like pantothenic acid and ethanol do not significantly influence the cytosolic N-acetyltransferase activity. Consequently they do not interfere with the acetylator phenotyping procedure.

Acetylation↗

Drug evaluation and registration in Hungary.

In Hungary, the actual drug evaluation and registration system reflects international standards and national traditions. The compulsory drug registration system that was established in 1933 was among the first in Europe. Laboratory control (since 1927), clinical trials (since 1951) and human clinical pharmaceutical experiments (since 1967) are prerequisites for new-drug approval. Applications should be sent to the National Institute of Pharmacy, which has the overall responsibility for the registration of pharmaceutical products. Applications are assessed on the basis of the drug's quality, safety, and efficacy. The procedure follows several steps: evaluation of chemical and pharmaceutical data by the staff of the National Institute of Pharmacy; evaluation of toxicologic and pharmacologic documentation with the help of the Committee on Drug Administration; after consultation with the Committee on Medical Research Ethics (mandatory in cases of original new drugs), authorized clinical pharmacologic investigations are conducted in the units of the Clinical Pharmacological Network, which are supervised by the National Center for Clinical Pharmacology; clinical trials; application for registration (scientific evaluation); and finally, application to the Ministry of Health for a marketing authorization. The process may be facilitated appreciably for preparations already registered in another country. Moreover, Hungary is an active member in the World Health Organization (WHO), Pharmaceutical Inspection Convention of the European Free Trade Association (EFTA PIC), the Council of Mutual Economic Assistance (COMECON), and other international pharmaceutical and clinical pharmaceutical collaborations.

Drug Evaluation↗

Pharmacogenetic differences in the inhibitory effect of cimetidine on the metabolism of antipyrine.

The relationship between acetylator phenotype and the inhibitory effect of cimetidine on the hepatic metabolism of antipyrine has been studied in 20 subjects. Cimetidine, 1,0 g/day resulted in a significant decrease in the metabolic clearance rate of antipyrine, but only in slow acetylators, as fast acetylators were less affected. No sex difference was observed. No major change occurred in the urinary excretion of D-glucaric acid, which means that cimetidine had not-affected that Phase II reaction. It did significantly decrease the urinary partial clearance rate of norantipyrine, leaving that of antipyrine and 4-OH-antipyrine unchanged, which suggests that cimetidine had preferentially inhibited the P450 isozyme that catalyses norantipyrine formation.

Acetylation↗

Comparative bioavailability study of two preparations of alpha-methyldopa after single, oral doses.

Bioavailability of alpha-methyldopa from a film coated tablet Dopegyt (EGIS Pharmaceutical Works, Budapest, Hungary) and from Aldometil (MSD, Sharp and Dohme GmbH, Munich, FRG) containing 250 mg of effective substance, was investigated in a crossover study in six patients with mild hypertension having normal renal and liver functions. Alpha-methyldopa was determined in plasma by fluorometry. There was no difference in the pharmacokinetic parameters calculated (Cl, Vd, AUC, t1/2) indicating that the two preparations are bioequivalent.

Adult↗