It’s a no-brainer for consumers to reach out to their medicine cabinets or seek an appointment with a doctor when they get sick. Still, others turn to natural home remedies before consuming commercially available medications.
Despite mixed consumer reactions, the pharmaceutical industry continues to enjoy stable growth yearly. In 2021, the sector’s value rose to USD$ 1.42 trillion, up from the previous year’s USD$ 1.26 trillion. Just 20 years ago, the industry posted a market size of only USD$ 390 billion.
Medications are often administered to the human body to address specific health concerns. So, they must be manufactured with the utmost care to minimize the risks of adverse effects on some individuals.
Because of the increasing demand in several markets worldwide due to the recent global health crisis and the rise of new diseases, drug manufacturing and biotechnology companies have grown to rely on reputable companies, including a sterile medical supplier, to ensure drug safety.
If you’re wondering how medications are made, dig in as we discuss the different stages of drug development.
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Stage 1: Drug Discovery
Every medication is hatched inside a laboratory, where a research team studies the onset of a particular disease and how it progresses. By analyzing this, the group can formulate a hypothesis on new or alternative treatments.
After identifying the culprits for disease progression, these experts will then study and determine a potential compound or molecule that could arrest or slow down the problem. It is a time-consuming exercise, even with genetic and protein analysis technologies.
Stage 2: Preliminary Screening
Once potential illness-busting molecules or compounds are determined, researchers will sift through the list, which can span a few thousand, to see which shows the best potential. At this stage, lab experts will test the potential medication compounds using animal cells, computerized models, or cultured cells to gather the initial efficacy and safety indicators.
While drug firms may be looking at lucrative revenues for developing a specific medication, the processes involved in making one are no laughing matter. Some experts estimate that it could take up to 15 years and several million, if not billions, in expenses to cover the entire drug development stages. A study has shown that creating one product could reach a median cost of USD $985 million.
Stage 3: Pre-clinical Development
This stage of drug development aims to identify how best to develop drugs to optimize their use. For instance, researchers can propose whether to manufacture the drug as an oral medication, a topical solution, or as a spray or injection.
In testing a promising compound or treatment modality, researchers will study the absorption and excretion mechanisms and rates, for instance, with oral antibiotics. The potential compound’s benefits, best dosage, and administration methods are also analyzed. Toxicity levels, adverse effects, and interactions with other drugs are likewise noted.
Once the figures and results are out, the laboratory that carried out the initial tests will have to apply for a clinical trial to test it on humans. A panel of scientific and medical experts will read through the results and evaluate whether the proposed treatment is safe for human testing.
Stage 4: Clinical Research And Development
This phase of drug development is also referred to as clinical trials, where the compound is tested on humans to validate safety and efficacy. There are four phases of clinical trials, the design of which is determined by the type of drug being pushed for commercial release.
- Phase 1: The treatment will be administered to a few clinical trial patients using controlled and uncontrolled methods, like a placebo or testing on groups of a specific gender or race.
- Phase 2: Researchers will validate the safety and efficacy of individuals with the illness or condition the drug is supposed to treat.
- Phase 3: Comparatively, the clinical trial team will test the proposed treatment with the other existing medications. The test will also include more people taking different medicines to discover the proposed drug’s toxicity levels and interactions with other medications.
- PPhase 4: Researchers will continue looking for potential adverse effects and the proposed treatment’s long-term impact. In some cases, the Food and Drug Administration (FDA) may already have approved manufacturers to exclusively sell the new therapy at this stage for a short period.
Post-development Evaluation
Following market approval, drug manufacturers and the FDA will continue monitoring the new medication’s effects. These organizations will keep in touch with pharmacies, healthcare workers, and individual consumers to gather issues with prescription and over-the-counter medications.
If potential issues arise, the FDA can issue added precautions to the public regarding usage or have the product pulled out, especially if the risks outweigh its benefits.
Wrapping Up
While medications are meant to ease symptoms and improve a patient’s quality of life, manufacturers are mandated to put a premium on consumer safety. The several stages of drug development discussed in this article are meant to ensure the efficacy and safety of new treatments before, during, and after their release. Every product must undergo these vital processes before they qualify for human consumption.
