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Human trials

Several of the products discussed herein are under intense development. One product, based on recombinant hemoglobin, is in early human trials as of this writing. Other hemoglobin-based solutions are also under review at the EDA. Replacement of red blood cells using massive amounts of protein, free in solution, is an unprecedented therapeutic adventure. [Pg.167]

To date, the most extensively studied polyboron hydride compounds in BNCT research have been the icosahedral mercaptoborane derivatives Na2[B22H22SH] and Na [(B22H22S)2], which have been used in human trials with some, albeit limited, success. New generations of tumor-localizing boronated compounds are being developed. The dose-selectivity problem of BNCT has been approached using boron hydride compounds in combination with a variety of deUvery vehicles including boronated polyclonal and monoclonal antibodies, porphyrins, amino acids, nucleotides, carbohydrates, and hposomes. Boron neutron capture therapy has been the subject of recent reviews (254). [Pg.253]

Erythrocyte Entrapment of Enzymes. Erythrocytes have been used as carriers for therapeutic enzymes in the treatment of inborn errors (249). Exogenous enzymes encapsulated in erythrocytes may be useful both for dehvery of a given enzyme to the site of its intended function and for the degradation of pathologically elevated, diffusible substances in the plasma. In the use of this approach, it is important to determine that the enzyme is completely internalized without adsorption to the erythrocyte membrane. Since exposed protein on the erythrocyte surface may ehcit an immune response following repeated sensitization with enzyme loaded erythrocytes, an immunologic assessment of each potential system in animal models is required prior to human trials (250). [Pg.312]

The process of initiating animal clinical trials is less arduous than for human trials. [Pg.131]

Unlike human trials. Institutional Review Boards/Independent Ethics Committees are not involved, while informed consent is only required from the owner of the trial animals. In addition to the standard items associated with human trials, aspects such as management and housing of animals, diet and disposal of trial animals and their produce should be included in the trial protocol. Studies may be blinded from the investigators in order to avoid bias in the reporting of animal observations. [Pg.134]

Animal studies suggest benefit but human trials are conflicting. More studies are needed. [Pg.157]

A recent meta-analysis was performed on all published human trials that used low-dose dopamine in the prevention or treatment of ARE20 A total of 61 studies were identified that randomized more than 3300 patients to low-dose dopamine or placebo. Results reveal no significant difference between the treatment and control groups for mortality, requirement for RRT, or adverse effects. [Pg.368]

The emphasis at this stage of the drug development process is upon assessing safety. Satisfactory pharmacological, and particularly toxicological, results must be obtained before any regulatory authority will permit commencement of human trials... [Pg.75]

As indicated in the discussion of axotomy models, the beneficial influences of trophic factors on motor neurons provide potential therapeutic opportunities. Although previous human trials have been disappointing (for review see [111,112]), adenoassociated viral (AAv) delivery of insulinlike growth factor (IGF)-l to muscle prolongs survival in mutant SOD1 mice [111]. Thus, following intramuscular injection, the retrograde transport of AAV-IGF-1 appears to provide trophic influences to motor neurons. [Pg.737]

A successful human trial of alum-adsorbed liposomes containing monophospho-ryl lipid A recently demonstrated that a formulation consisting of a combination of oil/water and adsorbent adjuvants can have considerable safety and efficacy and may be useful in the development of a potential vaccine against Plasmodium falciparum [29],... [Pg.8]

Neubert, R.T., Webb, J.R. and Neubert, D. Feasibility of human trials to assess developmental immunotoxicity, and some comparison with data on New World monkeys. Human Exper. Toxicol., 21(9-10), 543, 2002. [Pg.360]

Alpha-methylation of DMT reduced its behavioral activity in animals, while alpha-methylation of N-methyltryptamine (27) resulted in an agent with stimulant properties (137,228). Alpha-methyltryptamine (a-MeT structure 77), however, is hallucinogenic in man at doses of about 30 mg. Thus it is two to three times more active than DMT (for review see refs. 24, 81, and 196). 5-Methoxy-a-methyltryptamine (5-OMe-a-MeT 78) was also determined to be twice as active in man as its dialkyl counterpart, 5-OMeDMT. In human trials, 5-OMe-a-MeT produced behavioral effects at about 3 mg (204). A comparison of the activities of the individual isomers of 78 in man has not been reported. However, Glennon and co-workers (76,83,90) found that the (+)-isomers of both a-MeT and 5-OMe-a-MeT are more active than their racemates in tests of discriminative control of behavior in rats. Although (+)-5-OMe-a-MeT was four times more active than its enantiomer, (-)-a-MeT did not produce effects similar to either racemic a-MeT or 5-OMeDMT. [Pg.70]


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Animal Studies and Human Trials

Clinical trials First Human Dose

First-in-human clinical trials

First-in-human trials

Human experimentation/trials

Human intervention trials

Human pharmacology trials

Human pharmacology trials analysis

Human pharmacology trials goals

Human pharmacology trials limitations

Human pharmacology trials pharmacokinetic studies

Human pharmacology trials study designs

Human studies drug trials

Human subjects, clinical trials

Human trials long-term implantation

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