Pharmacological modeling and biostatistical analysis of a new drug

Abstract

Clinical research and clinical trials of experimental drugs to treat human diseases have gained greater importance in recent years. Phase I-IV clinical trials offer patients the opportunity to gain access to a new, more efficacious and safer medication to alleviate or cure their disease. There are potential side effects of every new drug; however, such trials and studies are crucial for drug development and testing in humans. The US Food and Drug Administration (FDA) regulated process of evaluating a new drug for treating a particular disease in humans is long, rigorous, and includes the stages starting from preclinical research through the entire human clinical trials process. This review synthesizes results from the above stages and describes the entire mechanism of the clinical study of a new drug for human disease. It emphasizes the associated mathematical modeling and statistical analyses, and bridges pharmacological modeling and biostatistics in clinical research and also provides a basic theoretical overview to biomedical experimentalists. The modern trend in clinical research involves a unified approach among several biomedical subspecialties and it is hoped that even more integrated studies of new drugs will continue to be carried out, leading to novel drugs that are highly effective in curing the associated condition.

<p>The European Medicines Agency Clinical Data Website Enables Insights Into Clinical Development Timelines And Strategy</p>

“…The number of protocol amendments may reflect the increasing amount of data becoming available, and it is unlikely that amendments to protocols can be eliminated. [28][29][30] The finding that 310 of the 444 clinical study protocols in the 15 core CDPs had amendments appears high ( Supplemental Table S3). However, it reflects the uncertainties faced and external information that becomes available and needs to be incorporated into clinical development.…”

A new conceptual framework for the therapy by optimized multidimensional pulses of therapeutic activity. The case of multiple myeloma model

“…The therapies can be delivered in periodic or other appropriate manner [48,59] instead of in one time only. As an alternative to focusing on the optimal number of the pulse repeats, we investigate the feasibility and robustness of the periodic extension of the results achieved for single pulse [see sec.3.3] without reoptimization for the periodic conditions.…”

Pharmacokinetics and Bronchopulmonary Disposition of PI3KDelta Inhibitor IC87114 after Intratracheal Administration in a Severe Asthma Model

“…Time versus BAL fluid concentration curves showed a clear distribution in the peripheral compartment. Thus, a high K cp /K pc ratio (estimated to be 5.28) was established to explain rapid distribution into the peripheral compartment [16] . In addition, the relationship between BAL fluid and plasma concentration of IC87114 was explained using the To evaluate the quality of the final model, Monte Carlo simulation with 1000 subjects was performed.…”