Clinical Drug Discovery Process

A Clinical Drug Discovery Process is a pharmacological process to discover new candidate pharmaceutical drugs.

• Context:
  • It can be a part of a Drug Development Process.
  • It can be followed by a Drug Evaluation Process.
  • …
• Example(s):
  • A Penecillin discovery process.
  • …
• Counter-Example(s):
  • a Clinical Drug Research Process.
  • a Clinical Drug Production Process.
• See: Pharmacotherapy, Pharmacology, Chemical Library, Classical Pharmacology.

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References

2023a

• (OpenAI-ChatGPT, 2023) ⇒ https://chat.openai.com/chat Retrieved:2023-3-5.
  • Question: Explain the drug discovery process.
  • Answer: The drug discovery process is a complex and multi-stage process that involves several years of research, testing, and evaluation before a new drug can be approved for use. Here are the general steps involved in the drug discovery process:
    • 1. Target identification: The first step in the drug discovery process is to identify a specific biological target, such as a protein or enzyme, that is involved in a disease process.
    • 2. Lead generation: Once a target has been identified, the next step is to identify potential compounds that can bind to the target and modify its activity. This involves screening large libraries of compounds using various techniques, such as high-throughput screening or virtual screening.
    • 3. Lead optimization: After identifying potential compounds, the next step is to optimize the compounds to improve their potency, selectivity, and other properties. This involves synthesizing and testing hundreds or thousands of variations of the lead compounds.
    • 4. Preclinical testing: Once a promising lead compound has been identified and optimized, it is tested in preclinical studies using animals to evaluate its safety, efficacy, and pharmacokinetics. This involves testing the compound's toxicity, absorption, distribution, metabolism, and excretion.
    • 5. Investigational New Drug (IND) application: If the preclinical studies are successful, an IND application is filed with the regulatory agency, such as the FDA in the US, to begin clinical trials in humans. The IND application includes data on the safety and efficacy of the compound from the preclinical studies.
    • 6. Clinical trials: Clinical trials are conducted in three phases to evaluate the safety, efficacy, and optimal dosage of the drug in humans. Phase 1 trials involve a small number of healthy volunteers to evaluate safety and pharmacokinetics. Phase 2 trials involve a larger number of patients with the target disease to evaluate efficacy and optimal dosage. Phase 3 trials involve an even larger number of patients to confirm efficacy and safety.
    • 7. New Drug Application (NDA) submission: If the clinical trials are successful, an NDA is filed with the regulatory agency to seek approval for marketing the drug. The NDA includes data from the preclinical and clinical studies, as well as information on manufacturing, labeling, and proposed use of the drug.
    • 8. FDA approval: If the regulatory agency approves the NDA, the drug can be marketed and prescribed by healthcare providers.

      The drug discovery process can take several years and cost hundreds of millions of dollars. However, the development of new drugs is essential for treating and preventing diseases and improving public health.

2023b

• (Wikipedia, 2023) ⇒ https://en.wikipedia.org/wiki/drug_discovery Retrieved:2023-2-24.
  • In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which new candidate medications are discovered.

    Historically, drugs were discovered by identifying the active ingredient from traditional remedies or by serendipitous discovery, as with penicillin. More recently, chemical libraries of synthetic small molecules, natural products or extracts were screened in intact cells or whole organisms to identify substances that had a desirable therapeutic effect in a process known as classical pharmacology. After sequencing of the human genome allowed rapid cloning and synthesis of large quantities of purified proteins, it has become common practice to use high throughput screening of large compounds libraries against isolated biological targets which are hypothesized to be disease-modifying in a process known as reverse pharmacology. Hits from these screens are then tested in cells and then in animals for efficacy.

    Modern drug discovery involves the identification of screening hits, medicinal chemistry and optimization of those hits to increase the affinity, selectivity (to reduce the potential of side effects), efficacy/potency, metabolic stability (to increase the half-life), and oral bioavailability. Once a compound that fulfills all of these requirements has been identified, the process of drug development can continue. If successful, clinical trials are developed.

    Modern drug discovery is thus usually a capital-intensive process that involves large investments by pharmaceutical industry corporations as well as national governments (who provide grants and loan guarantees). Despite advances in technology and understanding of biological systems, drug discovery is still a lengthy, "expensive, difficult, and inefficient process" with low rate of new therapeutic discovery. In 2010, the research and development cost of each new molecular entity was about US$1.8 billion. In the 21st century, basic discovery research is funded primarily by governments and by philanthropic organizations, while late-stage development is funded primarily by pharmaceutical companies or venture capitalists. To be allowed to come to market, drugs must undergo several successful phases of clinical trials, and pass through a new drug approval process, called the New Drug Application in the United States.

    Discovering drugs that may be a commercial success, or a public health success, involves a complex interaction between investors, industry, academia, patent laws, regulatory exclusivity, marketing and the need to balance secrecy with communication. Meanwhile, for disorders whose rarity means that no large commercial success or public health effect can be expected, the orphan drug funding process ensures that people who experience those disorders can have some hope of pharmacotherapeutic advances.

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