Human pharmacology studies

Development of an Application Unrelated to Original Approved Use. After initial approval, drug development may continue with studies of new or modified indications, new dosage regimens, new routes of administration or additional patient populations. If a new dose, formulation, or combination is studied, additional human pharmacology studies may be indicated, necessitating a new development plan. 

Whereas the care devoted by Kraepelin to the individual assessment methods was in some contrast to the more loosely handled experimental design and conditions, great importance nowadays is laid on details of design and statistical analysis of human pharmacological studies. The most important elements in the organization of such trials are ... 

How can this enigma be answered Put away a sample of pure harmaline, with its spectral identification, onto the shelf for 50 or 100 years, and then re-analyze it Who knows, but what might be needed for this conversion is heat, or a bit of iron catalyst, or some unknown species of South American mold. Acid is certainly known to promote this oxidation. It would be very much worth while to answer this question because some, perhaps much, of the results of human pharmacological studies that involve harmaline as a metabolic poison, may be influenced by the independent action of harmine as a harmaline contaminant. 

During human pharmacology studies, subjects are given extensive physical examinations before the administration of the drug, after its administration, and, in the case of longer term studies, at various intervals throughout the treatment. An extensive battery of typical tests includes ... 

Human pharmacology studies are designed to collect data that can be compared with similar types of data collected in nonclinical studies. Acute singledose studies are conducted first, with the dose used based on extrapolation from... 

For kinetics, an information on exposure data (AUC) in animals prior human clinical trials is needed while ADME data are needed at completion of Phase I (Human Pharmacology) studies. 

Microsomal hydroxylation at allylic carbon atoms is commonly observed in drug metabolism. An illustrative example of allylic oxidation is given by the psychoactive component of marijuana. J -tetrahydnx annabinol J -THC. This molecule contains three allylic carbon centers (C-7. C-6. and C-3). Allylic hydroxylation occurs cxten.sively at C-7 to yield 7-hydroxy- j -THC as the major pla.sma metabolite in humans. " Pharmacological studies show that this 7-hydroxy metabolite is as active as, or even more active than. J -THC per se and may contribute significantly to the overall central nervous system (CNS) p.sychotomimctic effects of the parent compound. Hydroxylation also occurs to a minor extent at the allylic C-6 position to give both the epimeric ba- and 6/3-hydroxy metabolites. " Metaboli.sm does not occur at C-3, presumably becau.se of steric hindrance. 

Fewer cephalosporins have been of clinical interest for oral administration. Studies of cefatrizine (BLS-640 SKF 60771) (7) have continued to determine in vitro characteristics,65-67 human pharmacokinetics,66 68,69 and clinical effectiveness.69-71 Extensive clinical trial data documented the effectiveness of cefadroxil (BLS-578 -OH cephalexin).72 Cefaclor (Lilly 99638) ( ) has been shown in in vitro studies to have better activity than cephalexin against gram-negative bacteria, especially H. influenzae. 56 60 73 7 The excellent oral absorption in mice, rats, and dogs paralleled that of cephalexin.75 Metabolism was observed in dogs76 but not in rodents. Human pharmacology studies indicated that cefaclor gave acceptable blood and urine levels.77... 

The ethical conduct of all clinical researchers is of supreme importance. Participants in all clinical trials are volunteers while the word "volunteers" is typically exclusively used to describe participants in human pharmacology studies, all participants in all clinical trials are, by definition, volunteers (see Turner, 2007). Individuals participate in clinical trials for the greater good, not specifically to benefit themselves. Everyone involved in clinical research has an obligation to conduct all aspects of this research to the highest ethical standards. 

I would like to suggest that this search for it the mechanism common to all phenethylamines represents a failure to recognize a richer and much more interesting phenomenon the dramatic differences in subjective effects exhibited by different phenethylamines. This failure may be due to the widespread but false belief that they "produce a very similar syndrome", a failure arising out of the paucity of good comparative human pharmacological studies. While there may be a receptor site such as 5-HT 2 that is bound by many phenethylamines, there must also be many other receptor sites that are affected differently by different compounds. 

No relevant human pharmacological studies were identified. Animal Pharmacological Studies... 

No relevant human pharmacological studies were identified. 

While one reference (Dugoua et al. 2006) noted low-level evidence suggesting potential hormonal activity of black cohosh could be a cause for concern during lactation, further studies indicated a lack of estrogenic activity of black cohosh (see Human pharmacological studies). 

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