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Healthy volunteers

Several authors measured attainable pressure drops as a function of the external resistance for different groups of volunteers. Healthy male subjects (during maximal inspiration) are able to create a pressure drop (on average) of 6.7 kPa through an airflow resistance of 0.038 kPa° min 1, (which is in the range of that of marketed DPIs, see Table 3.7), whereas females are able to create a pressure drop of 3.8 kPa under the same resistance [22]. Differences between different groups of patients depend on the degree to which pulmonary func-... [Pg.76]

The objective of clinical studies in the pharmaceutical industry is to assess whether a drug candidate will be effective in the treatment of a disease or condition, its risks of unwanted effects, and the relative relationship of these assessments (benefit/risk assessment). These studies must be conducted so that the participating volunteers (healthy subjects or patients) are exposed to the least possible risk consistent with the potential benefit, hi this context, clinical pharmacokinetics and pharmacodynamics in drug development is focused on three main objectives ... [Pg.75]

The preclinical trials are performed in in vitro and animal studies to assess the biological activity of the new compound. In phase 1 of the clinical trials the safety of a new drug is examined and the dosage is determined by administering the compound to about 20 to 100 healthy volunteers. The focus in phase II is directed onto the issues of safety, evaluation of efficacy, and investigation of side effects in 100 to 300 patient volimteers. More than 1000 patient volunteers are treated with the new drug in phase 111 to prove its efficacy and safety over long-term use. [Pg.602]

Blood can be collected ia the form of whole blood donations. In the United States, one unit, ie, 450 mL, of blood is collected from a healthy volunteer blood donor who is allowed to donate blood once every 10 weeks. A unit of blood is typically separated iato a red cell fraction, ie, red cell concentrate a platelet fraction, ie, random donor platelets (RDP) and plasma. [Pg.520]

Phase I. This involves general testing for human pharmacology in healthy volunteers, ie, safe-dose adjustment deterrnination of absorption, metabohsm, and excretion patterns and monitoring for side effects. Usually fewer than 10 test subjects ate involved. [Pg.225]

Muzolimine (710), a 1-substituted 2-pyrazolin-5-one derivative, is a highly active diuretic, differing from the structures of other diuretics since it contains neither a sulfonamide nor a carboxyl group. It has a saluretic effect similar to furosemide and acts in the proximal tubule and in the medullary portion of the ascending limb of the loop of Henle. Pharmacokinetic studies in dogs, healthy volunteers and in patients with renal insufficiency show that the compound is readily absorbed after oral administration (B-80MI40406). [Pg.296]

Eventually, the proposed method was successfully applied to quantify clarithromycin in spiked human plasma and real samples from healthy volunteers after oral administration of the dmg indicating the utility of this method for clinical and bioavailability studies. [Pg.395]

Clinical trials are usually divided into three phases. In phase I clinical trials, the new drug is tested in a small (20-80) group of healthy volunteers to evaluate its... [Pg.374]

The primary objective of a Phase I trial is to assess the safety of the drug in humans. Studies are normally conducted in healthy male volunteers, although specific categories of subject may be used in certain cases. For example, to avoid the risk of low blood pressure, subjects with mild hypertension would be more appropriate for the evaluation of antihypertensive drugs, while patients are likely to be used in the case of drugs that are expected to produce significant toxic effects (e.g. anti-cancer cytotoxic drugs). Remuneration may be offered for participation in the study. The number of subjects is normally between 10 and 100 people. [Pg.74]

Skarke C, Darimont J, Schmidt H, et al Analgesic effects of morphine and morphine-6-glucuronide in a transcutaneous electrical pain model in healthy volunteers. Clin Pharmacol Ther 73 107—121, 2003... [Pg.108]

Vermeeren A, Jackson JL, Muntjewerff ND, et al Comparison of acute alprazolam (0.25, 0.50 and 1.0 mg) effects versus those of lorazepam 2 mg and placebo on memory in healthy volunteers using laboratory and telephone tests. Psychopharmacology (Berl) 118 1-9, 1995... [Pg.161]

Bowdle TA, Radant AD, Crowley DS, et al Psychedelic effects of ketamine in healthy volunteers relationship to steady-state plasmaconcentrations. Anesthesiology 88 82-88, 1988. [Pg.261]

Olivera AA, Kiefer MW, Manley NK Tardive dyskinesia in psychiarric parienrs with substance abuse disorders. Am J Drug Alcohol Abuse 16 57-66, 1990 Palatini P, Tedeschi L, Prison G, er al Dose-dependent absorption and eliminarion of gamma-hydroxybutyric acid in healthy volunteers. Eur J Clin Pharmacol 45 3 53— 356, 1993... [Pg.265]

Dohrn CS, Lichtor JL, Finn RS, et al Subjective and psychomotor effects of nitrous oxide in healthy volunteers. Behav Pharmacol 3 19-30, 1992 Dohrn CS, Lichtor JL, Coalson DW, et al Reinforcing effects of extended inhalation of nitrous oxide in humans. Drug Alcohol Depend 31 263-280, 1993 Evans AC, Raistrick D Phenomenology of intoxication with toluene-based adhesives and butane gas. Br J Psychiatry 130 769-773, 1987 Evans EB, Balster RL CNS depressant effects of volatile organic solvents. Neurosci Biobehav Rev 13 233—241, 1991... [Pg.306]

Mertes PM, Moneret-Vautrin DA Skin reactions to intradermal neuromuscular blocking agent injections a randomized multicenter trial in healthy volunteers. Anesthesiology 2007 107 245. Moneret-Vautrin DA, Gueant JL, Kamel L, Laxenaire MC, el Kholty S, Nicolas JP Anaphylaxis to muscle relaxants cross-sensitivity studied by radioimmunoassays compared to intradermal tests in 34 cases. J Allergy Clin Immunol 1988 82 745. [Pg.189]

Rosenberg G, Angel I, Kozak A. Clinical pharmacology of dp-b99 in healthy volunteers first administration to humans. Br J Clin Pharmacol 2005 60 7-16. [Pg.115]

HOLLMAN P 0 H, DE VRIES J H M, VAN LEEUWEN S D, MENGELERS M J B and KATAN M B (1995) Absorption of dietary quercetin glycosides and quercetin in healthy ileostomy volunteers. Am J Clin Nutr 62, 1276-82. [Pg.103]

Based on a study conducted with 40 healthy volunteers, Lignell reported the effect of astaxanthin on mammalian muscle function. Volunteers received one capsule of 4 mg astaxanthin each morning in association with food. No significant difference was observed between the treatment and placebo groups in any physical parameters measured. [Pg.409]

Sato N, Sawada K, Takahashi TA, et al. A time course study for optimal harvest of peripheral blood progenitor cells by granulocyte colony-stimulating factor in healthy volunteers. Exp Hematol 1994 22 973-978. [Pg.85]

Liles WC, Broxmeyer HE, Rodger E, et al. Mobilization of hematopoietic progenitor cells in healthy volunteers by AMD3100, a CXCR4 antagonist. Blood 2003 102(8) 2728-2730. [Pg.136]

Phase 1 trials are the first in man studies of a new drug in humans. These studies are usually carried out on small samples of subjects. The idea here is to determine the safety of the drug in a small and usually healthy volunteer study population. [Pg.3]

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