"Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery."
Drug development refers to the process of discovering and testing new drugs for clinical use.
Drug discovery: Understanding the process of identifying, developing, and selecting compounds for drug development.
Preclinical testing: Understanding the animal-based testing done before clinical trials begin to establish drug safety and effectiveness.
Clinical trial design: Understanding how clinical trials are designed, how participants are recruited, and how data is analyzed.
Pharmacokinetics (PK): Understanding how drugs are absorbed, distributed, metabolized, and excreted by the body.
Pharmacodynamics (PD): Understanding how drugs interact with the body's cells, tissues, and organs to produce a therapeutic effect.
Mechanism of action: Understanding how drugs work at the molecular level, including drug-receptor interactions, enzyme inhibition, and signal transduction.
Drug metabolism: Understanding how the body breaks down drugs, including the roles of enzymes and genetic variation.
Toxicology: Understanding the study of the effects of chemicals on living organisms, including the assessment of drug safety and potential harm.
Regulatory affairs: Understanding the regulatory requirements for drug development, including the FDA approval process, drug labeling, and post-market surveillance.
Intellectual property: Understanding the legal protections for drug development, including patents, trademarks, and trade secrets.
Clinical pharmacology: Understanding the application of basic pharmacology principles to clinical practice, including dose-response relationships, drug interactions, and personalized medicine.
Biostatistics: Understanding the use of statistical methods to analyze complex data in clinical trials and other biomedical research.
Clinical research ethics: Understanding the ethical considerations in drug development, including informed consent, patient safety, and conflicts of interest.
Health economics: Understanding the economic principles and tools used to evaluate the costs and benefits of drug development and healthcare interventions.
Quality control and assurance: Understanding the importance of ensuring the safety, efficacy, and consistency of drug products, including manufacturing, testing, and quality control.
Discovery Research: This phase involves the identification of new drug targets and molecules that have the potential to become effective drugs.
Preclinical Research: Preclinical research involves testing drugs on animals to evaluate their safety, efficacy, and dosing parameters.
Clinical Development: The clinical development phase of drug development involves testing the drug in humans in a carefully controlled clinical setting to evaluate its safety and efficacy.
Clinical Trials: Clinical trials are a crucial part of the clinical development process. They involve testing the drug in human volunteers to evaluate its safety, efficacy, and side effects.
Special Populations: The development of drugs for special populations, including pediatric, elderly, and pregnant patients, requires additional testing and safety evaluation.
Pharmacokinetics and Pharmacodynamics: Pharmacokinetics and pharmacodynamics are essential aspects of drug development that involve studying how drugs interact with the body and how they are metabolized and excreted.
Biopharmaceuticals: Biopharmaceuticals are drugs that are produced using biotechnology, including recombinant DNA technology, to create complex molecules for specific applications.
Formulation Development: Formulation development involves creating a stable and effective drug product that can be safely and effectively administered to patients.
Regulatory Affairs: Regulatory affairs involve navigating the complex regulatory landscape of drug development, including obtaining approval for clinical trials and securing FDA approval for new drugs.
Post-Marketing Surveillance: Post-marketing surveillance involves monitoring the safety and efficacy of drugs once they are on the market to detect potential side effects and evaluate their long-term safety and effectiveness.
"It includes preclinical research on microorganisms and animals, filing for regulatory status, such as via the United States Food and Drug Administration for an investigational new drug to initiate clinical trials on humans, and may include the step of obtaining regulatory approval with a new drug application to market the drug."
"It includes preclinical research on microorganisms and animals."
"Filing for regulatory status, such as via the United States Food and Drug Administration for an investigational new drug, to initiate clinical trials on humans..."
"United States Food and Drug Administration"
"...to initiate clinical trials on humans."
"The entire process... typically takes more than a decade."
"Filing for regulatory status, such as via the United States Food and Drug Administration for an investigational new drug..."
"...from concept through preclinical testing in the laboratory to clinical trial development, including Phase I–III trials."
"...may include the step of obtaining regulatory approval with a new drug application to market the drug."
"From concept through preclinical testing in the laboratory..."
"Bringing a new pharmaceutical drug to the market..."
"...obtaining regulatory approval with a new drug application to market the drug."
"...clinical trials on humans..."
"The entire process typically takes more than a decade."
"Preclinical research, regulatory filing, clinical trials, and regulatory approval with a new drug application."
"...bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery."
"Preclinical research on microorganisms and animals..."
"...obtaining regulatory approval with a new drug application to market the drug."
"United States Food and Drug Administration"