Pharmaceutical medicine is a branch of pharmaceutical science that deals with targeted pathology of the human body. Pharmaceutical medicine could be described as a team effort with virtually all medical specialties. It has upgraded itself from bench to bedside and comprises not only pharmaceutical scientists, but also super-specialized doctors, doctor-scientists, chemistry experts, economy scientists, the business and government public professionals. The main function of pharmaceutical medicine is to provide, develop and discover medicines suitable to treat, cure, prevent and sometimes eradicate diseases completely. Currently, pharmaceutical medicine is a fully recognized and established branch of postgraduate studies. The students who graduate in pharmaceutical medicine are expected to have knowledge in basic science research, Pharmacoeconomics, clinical management, drug development, principles of clinical trials, public health, and the business of pharmaceutical medicine. [1] It’s important to note that pharmaceutical medicine has grown into a well-known branch in the world, especially in Europe. Physicians who practice pharmaceutical medicine are experts in clinical trials and are usually the primary investigators in new drug development trials.

Drug discovery phase

Anyone familiar with the drug development business knows that it takes a very long time to develop a fully approved functional drug. To be exact it takes 12 to 15 years [2] from the drug discovery, science, trials, and approval from regulatory agencies where a drug is going to be marketed. Drug discovery starts with basic research on the given disease. A group of scientists forms a hypothesis to understand potential challenges and efficacies in drug development in the human body. Once the basic research has been published and the hypothesis has shown some significance in being a real deal, then the next step of early development takes place. In the early development cycle, scientists test the hypothesis in the clinical scenarios of plants or animals to see if it has proven to be true. Once the theory is confirmed, the next step of the process is the Pre-Clinical phase. In the pre-clinical phase, scientists mimic the human body with in-vitro studies of various animals such as rats or dogs, as they show some sort of similarity to the human species. Once the scientifically sound papers have been finalized, the company or also called the sponsor submits papers to regulatory agencies for the New Drug Development Application also known as NDA or BLA (biological license application).

Upon approval of NDA, the sponsor moves to the clinical testing phase. In this phase real human testing is done in 10th, 100th, and even 1000th quantities of human beings being tested on the given hypothesis of the new drug development. The clinical development is broken down into clinical trial phases: [2]

1.     Clinical Trial Phase 1 (Healthy volunteers)

2.     Clinical Trial Phase 2 (Various patient populations). Placebo is used to randomize and blindfold the study to prevent physician/patient bias.

3.     Clinical Trial Phase 3 (Target patient population)

4.     Clinical Trial Phase 4 or also known as the post-marketing surveillance phase.

During clinical trials, things like pharmacodynamics and pharmacokinetics come into play. Pharmacodynamics deals with the targeted pathological organ and pharmacokinetics in simple words deal with the behavior of a new drug in the body and how it’s excreted. In the mentioned 3 phases, the sponsor company is surveying and monitoring the bioavailability of the drug and how it acts in the human body.

 After clinical trials are finalized, the next step is submitting the results for the final New Drug Application to the regulatory body such as the FDA. Once the proper studies and documentation are submitted, FDA thoroughly reviews the application and makes the final decision to approve or reject the application for the post-marketing phase. The agency’s review time can take up to a year from submission to final approval. Some drugs of public concern might receive accelerated approval, the one example of accelerated approval is the SARS-COVID-19 vaccine. It’s worth noticing that drugs may be denied due to their toxicity or efficacy to show results.

However, once the drug is approved the next step is called post-marketing monitoring or rarely called phase IV of the clinical trial. In this section of drug approval, the regulatory agency as well as the sponsor monitors the adverse events and unusual findings in patients. Even though the post-marketing phase is considered a finish line for the sponsoring company, the drug could be pulled completely from the marketplace due to complications or adverse reactions reported by the patients. The surveillance part of new drug development is critical for the drug to stay in the marketplace. However, there were instances when the drug was pulled from use due to adverse reactions years later.

References:

1.     “Pharmaceutical Medicine: Pharmacy Graduate Programs.” NEOMED, 20 Jan. 2022, www.neomed.edu/graduatestudies/integrated-pharmaceutical-medicine/.

2.     Hughes, J P et al. “Principles of early drug discovery.” British journal of pharmacology vol. 162,6 (2011): 1239-49. doi:10.1111/j.1476-5381.2010.01127.x