Question

How would you change the current pathways to FDA approval (Phase I-IV) studies to make the process more efficient and faster?

500 words no plagiarism no bullet points please

Answer 1

Ans) New Drug Approval Process:

- The company then submits an application (usually about 100,000 pages) to the FDA for approval, a process that can take up to two and a half years. After final approval, the drug becomes available for physicians to prescribe.

The FDA Center for Drug Evaluation and Research (CDER) is the watchdog for potential medications seeking approval for use in the United States. In order for CDER to begin evaluating a drug, pharmaceutical companies must first do extensive testing and document the results.

Those results are sent in to the CDER, who assigns a team of doctors, chemists, pharmacologists, and other scientists to review the evidence. From initial formulating to FDA approval, most drugs take around 10 years to make it to the market. This may seem unnecessarily long, but the result is that only the safest drugs make it to the pharmacy.

Phases of Drug Development:

Phase I:
- Discovery involves researchers finding new possibilities for medication through testing molecular compounds, noting unexpected effects from existing treatments, or the creation of new technology that allows novel ways of targeting medical products to sites in the body. Drug development occurs after researchers identify potential compounds for experiments.

Studies are conducted on appropriate dosage; methods for administration; side effects and how they may vary within different demographic groups; how the drug is absorbed, metabolized, and excreted; drug interactions, and how effective it is compared with similar compounds.

Phase II: Preclinical Research
Once researchers have examined the possibilities a new drug may contain, they must do preliminary research to determine its potential for harm (toxicity). This is categorized as preclinical research and can be one of two types: in vitro or in vivo.

In vitro refers to experimenting within a controlled environment outside of a living organism, while in vivo means the experiment occurs in a living organism. Both kinds of preclinical research must follow regulated laboratory practices, known as Good Laboratory Practices (GLP), which outline basic requirements for researchers, facilities, equipment, etc.

Preclinical studies are smaller than most clinical trials, but they must provide detailed evidence about appropriate dosing and toxicity levels. If researchers review the findings and determine it is safe to test in humans, drug development moves on to Phase III.

Phase III: Clinical Research
After the safety of a drug is determined, researchers must examine the ways in which drugs interact with the human body. Clinical research involves trials of the drug on people, and it is one of the most involved stages in the drug development and approval process. Clinical trials must answer specific questions and follow a protocol determined by the drug researcher or manufacturer. To design a study, researchers must determine its length and scope, as well as who can participate and how the data will be collected and analyzed.