Steps in Research Process in Breast Cancer Drug-Tucatinib

Discussion Thread: Understanding Drugs
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Steps In Research Process in Breast Cancer Drug-Tucatinib
The pharmaceutical research process is governed by protocols that serve as the basic outline. Developing a new drug is a complex process with many challenges. The process can take more than a decade. Usually, the period between the testing of a drug and its approval may vary but typically take 10-15 years. During this period, a drug undergoes research and development phases, testing, clinical trials, approvals, and licensing by the relevant regulatory bodies, e.g., Food and Drug Association (FDA) or European Medicines Agencies (EMA). This process is divided into four phases;
Phase 1- After discovering a new drug, its efficacy and safety are examined. This phase mainly involves laboratory testing to isolate or determine the target molecule (Deore et al., 2019). it also involves identifying the maximum dosage that can be used without severe safety effects. The testing is mostly done on animals. Phase 2- This is the preclinical research phase. The drug is tested for its effectiveness. The drug is tested to determine whether it can reach its endpoint biomarkers, and patient-related outcomes are observed, e.g., can the drug cause toxicity in humans? (Deore et al., 2019). Is there a progression-free survival chance? Thereafter, clinical trials on humans are allowed through regulatory bodies like Clinical Trial Applications (CTA) or Investigational New Drugs (IND)  
Phase 3- following approval for clinical trials on humans. A group of healthy volunteers. This is to ascertain whether the drug will have the same effect as in the preclinical findings. This phase involves checking the safety profile, i.e., the safe dosages and bioavailability componen...