The life cycle of drug development is a complex and multi-step process that typically takes several years and involves multiple stages, including:
Discovery and Development: This is the initial stage of drug development, where researchers identify and investigate potential drug targets. Scientists may use various techniques such as high-throughput screening, computational modeling and genetic engineering to identify new drug candidates.
Preclinical Development: In this stage, researchers conduct laboratory and animal testing to determine the safety and effectiveness of the drug candidate. This includes in vitro (test tube) studies and in vivo (animal) studies to evaluate the drug’s pharmacology and toxicology.
Clinical Development: This is the stage where the drug is tested in human volunteers and patients. It is divided into three phases:
Phase 1: The drug is given to a small group of healthy volunteers to determine its safety and to identify any side effects.
Phase 2: The drug is given to a larger group of patients to determine its effectiveness and to further evaluate its safety.
Phase 3: The drug is given to a large group of patients to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug to be used safely.
Regulatory Review and Approval: After clinical trials are completed, the drug’s sponsor submits an application to the regulatory agencies, such as the US FDA (Food and Drug Administration) and EMA (European Medicines Agency), for review and approval.
Post-approval Surveillance: After the drug is approved, it is closely monitored to ensure its safety and effectiveness. This includes tracking any adverse reactions, monitoring for long-term side effects, and making any necessary changes to the drug’s labeling and packaging.
Discontinuation: If a drug is no longer effective or if it is not profitable for the company, it may be discontinued.
The entire process of drug development can take several years and cost millions of dollars. It is a complex and lengthy process that requires significant resources, including funding, expert researchers, and specialized equipment. Even after a drug is approved, it may take several more years for it to become widely available to patients.