Clinical test evaluation

Naltrexone in combination with lactide/glycolide copolymer has been investigated (83-87). Chiang (85) reported the clinical evaluations of a bead preparation containing 70% naltrexone and 30% of a 90 10 lactide/glycolide copolymer. Each subject received a 10-mg i.v. dose of naltrexone and a 63-mg dose by subcutaneous implantation of the beads. Average plasma naltrexone levels were maintained at 0.3-0.4 ng/ml for approximately 1 month. Two out of three subjects experienced a local inflammatory reaction at the site of implantation. This unexplained problem prevented further clinical testing of... 

ICH S7B Note for Guidance on the Non-clinical Evaluation for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals Describes a non-clinical testing strategy for assessing the potential of a test substance to slow ventricular repolarization. Includes information concerning non-clinical assays and integrated risk assessment Anon.42... 

Performance trials and evaluation tests on the technique indicate that it is both rehable and accurate, and, in addition, that the specificity is sufficient to cope with most chnical requirements. An evaluation was made by Haeckel et al. [19]. If this approach is successful, the dispensers and tubes in laboratories will become redundant. It may well become possible for a clinical test to be undertaken close to the patient rather than in the laboratory. Whilst the techniques have as yet been used only for clinical analyses, there are many other potential applications, for example in the water industry. However, the very nature of the technique necessitates development by Eastman Kodak. Very few users will be able to influence the choice of analytical problems to be tackled by this unique approach. 

Given the need for development and clinical testing of novel drugs in patients, and the right of each patient to benefit from optimal treatment, there is obviously a conflict of putposes in clinical research that has been and still is evaluated differently at different times and under different circumstances. Opinion today is that a patient should, whenever possible, be the master of his own fate and not be delivered defenseless to the doctor an opinion that has been reflected in laws and guidelines. 

Physicians evaluate the results of clinical tests—including adverse and therapeutic effects, and whether the proposed labeling accurately reflects the effects of the drug. 

A 59-year-old woman presents to an urgent care clinic with a 4-day history of frequent and painful urination. She has had fevers, chills, and flank pain for the last 2 days. Her physician advised her to immediately come to the clinic for evaluation. In the clinic she is febrile (38.5°C [101.3°F]) but otherwise stable and states she is not experiencing any nausea or vomiting. Her urine dipstick test is positive for leukocyte esterase. Urinalysis and urine culture are also ordered. Her past medical history is significant for three urinary tract infections in the past year. Each of these episodes was uncomplicated, treated with trimethoprim-sulfamethoxazole, and promptly resolved. She also has osteoporosis for which she takes a daily calcium supplement. The decision is made to treat her with oral antibiotics for a complicated urinary tract infection with close follow-up. Given her history what would be a reasonable empiric antibiotic choice Depending on the antibiotic choice are there potential drug interactions she should be counseled on ... 

Figure 12 Degree of exocrine pancreas insufficiency in various clinical conditions evaluated by (he indirect ponciedauiyl test N is the number of patients studied. (Fiom Ref. 5Z)...

The same strain of cultured T-lymphoma cells as was used in the experiments discussed above has been tested for its sensitivity against antineoplastic drugs (Figure 12). Such experiments are believed to become important in drug developments and, possibly, in predictive clinical tests but have not yet been analyzed or evaluated in much detail. 

Von Recum AF (1986) Handbook of biomaterials evaluation, scientific, technical, and clinical testing of implant materials. Macmillan Press, New York... 

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