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Biomedical subjects

M A Eldon

Publications and source records attributed to M A Eldon.

24 records · Page 2Linked to original sources

Design of initial dosage regimen using a programmable calculator.

A programmable calculator procedure for the determination of dosage regimens to achieve desired steady state concentrations is described. The dosage regimen prediction is based on data from the literature on pharmacokinetic parameters of drugs and correction factors specific for the patient's condition, such as renal failure, geriatric patient and congestive heart failure. The program is designed to generate dosage regimens based on desired steady state trough level, desired steady state peak level, desired mean steady state level, or to fluctuate between desired steady state peak and trough levels. The program can be used for I.V. and extravascular route of administration. A detailed program description and user instructions are presented and illustrated by three examples.

Aged↗

Pilot study on the absolute and relative bioavailability of Synthroid and Levothroid, two brands of sodium levothyroxine.

The absolute and relative bioavailability of levothyroxine was determined in young, healthy male subjects after administration of i.v. solution, p.o. solution, or one of two brand-name, commercially available tablets. The mean dose size was about 0.18 mg. Serum concentration-time data were obtained over a period of 50 h. The absolute bioavailabilities of the two tablet preparations were 66% and 72%, respectively.

Adolescent↗

Gastric potential difference as a model in clinical pharmacology: assessment of gastric mucosal response to aspirin.

Gastric potential difference in 16 healthy subjects (GPD) was measured on three different days to assess baseline variability. The effect of three different doses of aspirin on PD in 19 additional subjects was determined. Several new parameters are suggested for better description of the GPD changes following ingestion of known gastric irritants. From these parameters, a Reiz Index (RI) was calculated as a single term representing the extent and severity of the GPD response to aspirin. One-way Anova followed by Scheffe comparisons showed significant differences between the mean RI values resulting from the administration of aspirin 250, 500 and 1000 mg.

Aspirin↗

Comparison of choline theophyllinate and theophylline gastric irritation utilizing gastric potential difference as a model.

Choline theophyllinate and theophylline were administered to 14 healthy volunteers following which the irritant effects of each drug were determined by measuring changes in gastric potential difference (GPD). Theophylline was found to be 2 and 3 times more irritating than choline theophyllinate in terms of mean membrane instability time and mean irritation index parameters, respectively. Considerations after the study indicated that the crossover design utilized was an efficient study design for the GPD model.

Adolescent↗

Bioavailability of propranolol hydrochloride tablet formulations: application of multiple dose crossover studies.

Two multiple dose crossover pharmacokinetic studies were carried out to determine the steady-state bioavailability of newly formulated generic propranolol HCl tablets relative to Inderal tablets. In Study I, 24 healthy volunteers were dosed with 4 x 10 mg test tablets, 1 x 40 mg test tablet, 4 x 10 mg Inderal tablets, and 40 mg of propranolol HCl in solution. In Study II, 24 healthy volunteers were dosed with 1 x 80 mg test tablet, 1 x 80 mg Inderal tablet, and 80 mg of propranolol HCl in solution. Both studies were of randomized design with each formulation administered every 8 h for 15 doses. Serial plasma samples were obtained for 8 h after morning doses on Days 4 and 5 of each treatment period and assayed for propranolol using a validated HPLC method. Mean plasma concentration-time data for test tablets and reference tablets were superimposable in both studies. Pharmacokinetic parameters from Days 4 and 5 were combined for statistical analysis since subjects were determined to have reached steady-state. Mean AUC, Cmax, tmax, and Cmin values were not statistically different between test tablets and Inderal tablets in either study. Based on these findings, the test tablets demonstrated the same rate and extent of propranolol absorption as did corresponding Inderal tablets. Therefore, the test tablets and Inderal tablets were determined to be bioequivalent.

Biological Availability↗