Disease outbreaks and epidemics continue to threaten the mere existence of human life. The unprecedented rise in the number of diseases has led to the devastating increase in the rates of global mortality and morbidity. It is for this profound reason that scientists have been tasked with the responsibility of finding effective drugs among other medical interventions all in an attempt to alleviate human sufferings and death caused by diseases. Through clinical drug development projects, scientists have made remarkable progress in developing essential medications for the management and treatment of a myriad of diseases. The clinical drug development entails several crucial steps that include; proof of pharmacological principle, proof of clinical principle, proof of clinical concept, patient selection, and safety. Vigorous research is usually done with an aim of studying pharmacodynamics and pharmacokinetics mechanisms of the drug within the human body. This allows scientists to get a clear picture on the effects, efficacy, and safety of the specific drugs in question (Faure 6). The successful development of clinical drugs occurs in sequential phases that commences with preclinical development, clinical development, launch, high growth, and market maturity. Additionally, medical affairs are key players in the final stages of clinical drug development project.
From my earlier lecture, it is evident that medical affairs play an integral role in the final process of clinical drug development. Aside from understanding the pharmacokinetics and pharmacodynamics of clinical trials, I also anticipate to expand my knowledge on the role played by medical affairs during the drug development process. I seek to learn on the role played by medical affairs in providing a platform for interaction among the pharmaceutical industries, the stakeholders, and the community (Hopkins et al. 78). This will not only assist me to comprehend the pre-clinical findings but also the post-clinical findings of the developed drug. In essence, studying medical affairs will assist me to understand the different roles played by the community, stakeholders, and pharmaceutical industries during the clinical drug development process.
Works Cited
Hopkins, Fran, Cassandra Galligher, and Abigail Levine. “Medical affairs and drug information practices within the pharmaceutical industry: results of a benchmarking survey.” Drug information journal 33.1 (1999): 69-85.
Faure, Marie-Odile. “Medical affairs writing: A key role to relay medical information to everyone.” Medical Writing 25 (2016): 6-8.