Int J Clin Pharm Th
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Int J Clin Pharm Th · Dec 1999
ReviewAlternative strategies in drug development: clinical pharmacological aspects.
Due to the continuous increase in time and cost of drug development and the considerable amount of resources required by the traditional approach, companies can no longer afford to continue to late phase 3 with drugs which are unlikely to be therapeutically effective. The future challenge must be for the pharmaceutical industry to slash its research and development costs by achieving a significant cut in the attrition rate for drugs entering preclinical and clinical development, and to reduce the development time and to increase the probability of success in later clinical trials by streamlining the development processes. In the 100 years to 1995, the pharmaceutical industry worked on about 500 targets with a limited number of compounds, whereas now, using new technologies like genomics, high throughput screening and combinatorial chemistry, drug companies will see an explosion in the number of targets and leads it can explore. ⋯ The more thorough and profound studies have been carried out during this exploratory stage of development, the earlier a decision can be made on the continuation or discontinuation of further development, thus saving development time and money and assessing and considerably reducing the risk for the patients and increasing the success-rate of the project in the later confirmatory effectiveness trial. Taking responsibility as the link between research and development gives clinical pharmacology a major opportunity to assume a pivotal role in research and development of new drugs. To reach this goal, clinical pharmacology must be fully integrated in the whole process from the candidate selection to its approval.
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Int J Clin Pharm Th · Oct 1999
Randomized Controlled Trial Comparative Study Clinical TrialAddition of intrathecal midazolam to bupivacaine produces better post-operative analgesia without prolonging recovery.
The administration of midazolam by centroneuraxis route has been shown to produce segmental antinociception. This midazolam analgesia was found to enhance the effects of local anesthetics given in combination epidurally without any adverse effects. The present study was designed to evaluate the post-operative analgesic effect of intrathecal midazolam-bupivacaine mixture in patients undergoing knee arthroscopy. ⋯ The results suggest that addition of midazolam to bupivacaine intrathecally provided better post-operative analgesia without any adverse effects.
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Int J Clin Pharm Th · Oct 1999
Effect of plasma alpha1-acid glycoprotein concentration on the accumulation of lidocaine metabolites during continuous epidural anesthesia in infants and children.
Alpha1-acid glycoprotein (AAG) is an acute-phase protein that is responsible for binding basic drugs such as lidocaine (LDC). The effect of AAG on the duration of LDC during continuous epidural anesthesia in infants and young children was investigated. ⋯ Our results suggest that the plasma AAG concentration is a valuable index in preventing the toxicity caused by accumulation of MEGX during continuous epidural anesthesia of LDC.
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Int J Clin Pharm Th · Aug 1999
Randomized Controlled Trial Comparative Study Clinical TrialComparison of tilidine/naloxone, tramadol and bromfenac in experimental pain: a double-blind randomized crossover study in healthy human volunteers.
The analgesic efficacy and safety of single oral doses of two centrally acting compounds, the combination of 50 mg tilidine and 4 mg naloxone (Valoron N) and 50 mg tramadol (Tramal), were compared to 25, 50 and 75 mg of the non-steroidal antiinflammatory bromfenac in experimental pain. ⋯ The results support previous conclusions about the analgesic efficacy of tilidine/naloxone and tramadol in experimental pain. Moreover, the findings suggest that 75 mg bromfenac might be suitable for fast but short relief of pain of non-inflammatory genesis.
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Int J Clin Pharm Th · Jun 1999
Limiting cefotaxime pediatric dosing to adult standards: a pharmacokinetic simulation study.
The recommended cefotaxime dose of 50 mg/kg every six to eight hours for pediatric patients with a body weight greater than 20 kg exceeds the standard 1-gram dose recommended for adult patients. This study estimated whether limiting the cefotaxime dose recommended for children with mild to moderate infections to a standard 1-gram dose would achieve serum concentrations and time above the MIC90 comparable to those in adults. ⋯ The results support the concept of limiting cefotaxime dosage regimens to 1 g administered every 6 or 8 hours for mild to moderate infections in children weighing more than 20 kg. This dosage regimen could lead to dose standardization procedures, which could produce reductions in drug costs associated with individualized dosage preparation.