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Drug Development and Discovery (D3) : An overview of the drug discovery process and its development.
Revision notes
STEPS
Discovery and development
As the initial point, it starts by understanding the disease, it involves:
TARGET DISCOVERY: studies more about the nature of the protein involved and
DRUG DISCOVERY: identifying the chemical or biological compound [drug candidate] that can modulate the targeted protein to alter the disease.
Methods:
- High-throughput screening
- Computer-based design
Preclinical research
This study aims at providing information about the safety and metabolism of the drug in animals. It involves several experiments conducted to obtain the results about safety and enhance pharmacokinetic (ADME) properties of the drug candidate before its mass production. Under the use of animals, Refining, Replacing, and Reducing should be applied as well as following government and regulatory authorities' guidelines to avoid animal rights harm and their misuse.
Clinical research
It involves the several stages of clinical trials done in humans to study the effectiveness and test the safety of the so-called hit drug candidates.
Phase I: drug candidate is tested in healthy volunteers to determine its safety and pharmacokinetics(ADME).
Phase II: drug is given to about 100-250 humans with the diseases to evaluate its efficacy and determine the optimal doses, safety, and side effects.
PoC: Proof of Concept combine these two for a fast process.
These two provide the data necessary to proceed to the more extensive clinical trials.
Phase III: Studies are conducted on about 1000-3000 or even more to confirm the effectiveness and monitor the side effects by comparing to the established treatment and gathering the information to allow the usage of the drug safely.
FDA Review
To bring a new medicine on the market, every new drug should be registered by the health authority. The registration process involves collecting all the data from all clinical studies and files into one document known as Registration Dossier. This document includes both efficacy and safety data to support the intended use of the drug. It is then submitted for evaluation to different health authorities around the world to meet the requirements of health authorities.
This step is crucial and ensures that the patient all over the world can take the innervated medicine safely.
After completion of this step, the drug is registered and launched.
FDA post-market Safety monitoring
Upon the introduction of a newly released product for public use, it becomes imperative to undertake a crucial and obligatory procedure known as Drug Safety Monitoring. During this process, an already established medication undergoes a series of pharmacovigilance measures aimed at gathering supplementary data that may not have been obtained during the Phase III stage. Such data encompasses adverse effects, as well as safety, efficacy, and drug economical information, as mandated by the relevant health authorities. This post-marketing Phase IV clinical trial remains in effect for the duration that the drug remains available on the market.
THE NEED FOR D3
D3 helps us to:
- design drugs for newly occurring diseases
- modify drugs to reduce and control side effects as well as meet the intended effects.
- discover and design drugs for untreatable conditions
- control drug resistance by designing new drug candidates
- collecting the data related to adverse effects.
Abstract
Abstract
Background and Objectives: In drug research and development whereby, the patient is the main focus, the mission is to overcome the disease and improve the quality of life. The process is designed to ensure that the newly produced medicines are SAFE, EFFECTIVE, and available for the patient in a brief period. As per FDA, drug development and discovery involve five main steps: discovery and development, preclinical research, clinical research, FDA review, and FDA post-market safety and monitoring.
With several disease outbreaks, drug discovery, and development has been essential tool in saving lives and ensuring the standard health status. Through research, it brings new drugs into the market against targeted diseases. With the aim of D3, the drugs are assessed under surveillance and monitoring to ensure their safety and efficacy.
Methods: Several methods have been generated to develop drugs in a brief period. Following the FDA process of drug development and discovery, a technological method is set per each step, these include computerized methods like High-throughput screening and Computer-based design used in designing a drug hit candidate and the use of pharmacological software to study the mechanism of action of the disease as well as the effectiveness and metabolism of the drug.
Results: Different studies show that research and development of drugs through drug discovery has been an essential tool in ensuring a better quality of life. It helps us understand the health condition allowing us to design drugs for newly occurring diseases and even previously untreatable conditions.
Conclusion: To play a vital role in saving lives and ensuring the best health status, it is important to understand the process of D3. FDA uses the data provided in the process to decide on different complications found in both prescribed and OTC drugs, hence controlling the serious adverse effects. This improves the process functioning as well as raises the quality of research and development.
Content
Author and article information
References
Singh Natesh, Vayer Philippe, Tanwar Shivalika, Poyet Jean-Luc, Tsaioun Katya, Villoutreix Bruno O.. Drug discovery and development: introduction to the general public and patient groups. Frontiers in Drug Discovery. Vol. 3:2023. Frontiers Media SA. [Cross Ref]