The Pharmaceutical Development Process
The pharmaceutical development process is a painstakingly lengthy one. From concept to bedside, the formation, approval and manufacturing of a drug can easily take ten to fifteen years, almost one-third of the lifespan of our professional careers.
There are very few incidents when medical investigative teams have to expedite the pharmaceutical development process. This only happens when a drug or vaccine is the first treatment option available for a grave disease, such as the COVID-19 for example.
Before the pharmaceutical world can use a new drug or treatment for patients, it has to go through series of rigorous testing. During the lengthy clinical trials, a new drug or treatment has to verify its safety for patients, its efficacy in curing the disease it is targeting and the correct dosage to administer,
Regulatory authorities, such as the FDA, overlook the entire drug development process; a new drug only wins its approval once it has passed through all rigorous testing standards. Let’s take a detailed look at the all stages of the pharmaceutical development process below.
1. Discovering the Potential Drug
In the early stages of discovery, academic experts and scientists collaborate on a series of steps regarding the potential new drug. They consider the specific disease they’re targeting and work on optimizing the drug’s compounds.
The discovery phase also involves the experts trying to make the targeted drug effective for treating the targeted disease. During this phase, the industry scientists and academic experts conduct tests in laboratories and on animal subjects.
2. Preclinical Testing
The second stage of the pharmaceutical development process includes the preclinical testing phase. In this, the investigative team of experts looks at the potential drug’s efficacy and safety in human subjects. This phase only begins when the investigative drug has passed the laboratory testing on animal and in vitro models.
Since the drug candidate now has to prove its biological effects, it therefore, performs on in vivo and in vitro models in the second stage. The information that this stage delivers is vital for the regulatory authorities.
The MHRA and FDA for instance, require preclinical research before they can allow the investigative drug candidate to proceed to clinical development. During this step, the focus is upon the following:
- How the drug will affect the body?
- How will the body react with the drug?
- Is the drug sage, even if it is potent?
During this stage of the drug development process, a few other key considerations have to be observed. The first is that the investigative teams must only use the most appropriate animal models. Similarly, it is also crucial to consider the gender of the animals when testing a potential drug.
The ultimate goal of a drug is not to be gender-specific, especially if it is targeting a gender-unbiased disease. It is common for a potential drug to often affect a male animal differently than a woman. Other key considerations include the genetics and metabolic pathways of the physiology of specific species. The example of mouse genes is apt here which overlap human ones by approximately 99%.
3. Application of the Investigative Potential Drug
In U.S.A, the FDA regulatory authority categorizes potential new drugs or INDs into three. Let’s take a look them below:
- Treatment- this is the category where pharmaceutical companies have to submit IND application for gaining access to an experimental drug. One can submit this application if a potential drug has shown promises of treating a life-threatening, serious or chronic disease in clinical trials. When the clinical trial work completes, the FDA reviews the application.
- Emergency use-This category refers to an IND application where the regulatory authority, like FDA, can approve a new drug in an emergency. They do not follow the obligation of abiding by an IND application under Sec. 312.20 or Sec. 312.23.
- Investigator- is the second category and physicians who initiate and investigate a potential drug submit this application. They do that to request studying an approved or unapproved drug for using it in a diverse population or an unlicensed indication.
4. Clinical Research
The next step of a pharmaceutical development process includes the clinical research. In this, the experts design a study model, including:
- The research questions that the investigational new drug will address
- Preparing the study protocol document that will outline each step on conducting the trial
- The document will also detail key objectives including statistical considerations, study design and objectives.
- The logistical details, including clinical supply services
- Ensuring safety of trial volunteers
- Ensuring the integrity of study data
The clinical research also includes a series of phases of the drug development. These include:
- Phase I- this phase involves around twenty to hundred volunteers. These can either be very healthy participants or those who are suffering from the disease the new drug is targeting. This phase determines the safety of the drug and its appropriate dosage to administer.
- Phase II- this phase involves several hundreds of volunteers. The participants are those who are suffering from the disease the new drug is targeting and the study can last for several months to two years. This phase determines the safety, efficacy, risks and benefits of the drug. It uses the information for optimizing the next study phase’s design.
- Phase III- This one involves around three hundred to three thousand participants, already suffering from the targeted disease. The investigative teams will administer dosages of the new drug to the vast number of people, to observe its long-term effects, adverse reactions and rarer side.
5. FDA Review
Based on all the information and evidence the lengthy clinical trial phases have gathered, the FDA reviews the drug. It is in this phase that the FDA or other regulatory authorities decide to approve or disapprove a new drug.
6. Post-Market Surveillance
After the approval and manufacturing process, the regulatory authorities require the pharmaceutical companies to monitor the safety of their approved drug using their system database. With this system of post-marketing surveillance, the consumers, healthcare professionals and manufacturers etc. can report problems with the new drug.
The need for new drugs and treatments in constantly on the rise as varieties of diseases continue to plague the world. This is where the pharmaceutical development process plays the most vital role, right from the birth of the new drug or treatment concept to its manufacturing and distribution process.