Hence, QSPR approach saves resources by predicting drug release from an unformulated formulation; avoiding repetitive trials in the development of a new formulation and/or optimization of existing one.
The observed small study effect in the current analysis may also be due to such a true heterogeneity (Higgings, 2008), as a short-term benefit from chemotherapy is more likely in patients with high-performance status for tolerating toxicity of the treatment and such patients are more likely to be included in small, early phase clinical trials in the development of new treatment regimens.
Despite the prominence of human laboratory and clinical trial research in the development of interventions for substance use disorders, this research presents numerous ethical challenges.
Understanding clinical trial data in the development of antibiotics to S. aureus is complicated by heterogeneous clinical outcomes (that is, length of hospitalization, mortality, treatment response), which makes interpretation of drug efficacy challenging.
YSC participated in the implementation of the clinical trials, assisted in the development of the E drs model, and helped to draft the manuscript.
AK is the biostatistician for the trial and involved in the development of the analysis plan.
Therefore, these potential risk factors as well as others that were captured within the clinical trial were considered in the development of each prediction model and the associated scoring algorithms.
14 Collecting pharmacokinetic data in paediatric drug trials is fundamental in the development of a larger body of evidence on the safety and efficacy of children's medicines.
To be able to do so, non-commercial organisations that wish to act as sponsor in clinical trials should invest in the development of adequate legal, administrative and management skills, just as they do for scientific skills.
Because receptors for BN/GRP are present on a high percentage of human glioblastoma cell lines, it is likely that further studies with AN-215 followed by therapeutic trials could result in the development of a new therapeutic approach for the management of patients suffering from advanced glioblastomas.
