Notes in 06. Drug Development Process

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Status	Last Update	Fields
Published	10/21/2024	In the Drug Discovery phase, new drug targets or promising molecules are identified through {{c1::screening, chemical modification, or rational design…
Published	10/21/2024	Preclinical testing involves {{c1::safety and efficacy studies}} in cell cultures and animals to determine the pharmacologic profile and toxicity of a…
Published	10/21/2024	Clinical Trials for drugs involve testing in humans through:phase 1 {{c1::safety}}phase 2 {{c1::efficacy}}phase 3 {{c1::large-scale}}
Published	10/21/2024	During the FDA Review phase, a {{c1::New Drug Application (NDA)}} is submitted with all preclinical and clinical data for FDA evaluation and approval
Published	10/21/2024	{{c1::Post-Marketing Surveillance}} includes the ongoing monitoring of drug safety and efficacy after market release, also known as {{c1::phase 4}}
Published	10/21/2024	Animal testing is conducted to assess both {{c1::toxicity}} and {{c1::efficacy}} of a drug
Published	10/21/2024	The drug development process starts with {{c1::in vitro}} studies, followed by {{c1::animal}} testing to assess efficacy, selectivity, and mechanism
Published	10/21/2024	The first clinical testing phase is called Phase 1, involving {{c1::20-100}} subjects to determine if the drug is safe and how it behaves in the body …
Published	10/21/2024	The second phase of clinical testing, known as Phase 2, involves testing the drug on {{c1::100-200}} patients to see if it works
Published	10/21/2024	Phase 3 involves {{c1::1,000-6,000}} patients and assesses whether the drug works effectively in a {{c1::double-blind}} study
Published	10/21/2024	Following the completion of Phase 3, a {{c1::New Drug Application (NDA)}} must be filed to seek approval for the drug
Published	10/21/2024	Drugs require multiple {{c1::permits}}, which is why it takes years to develop them
Published	10/21/2024	Once a drug passes animal testing, it is considered an {{c1::investigational drug}}
Published	10/21/2024	Investigational drugs undergo {{c1::clinical testing}} through various phases
Published	10/21/2024	After Phase 3, the drug is classified as a new drug and needs approval from the {{c1::FDA/NDA}}
Published	10/21/2024	Once the patent expires, {{c1::generic alternatives}} become available
Published	10/21/2024	Patent expires {{c1::20}} years after filing of application
Published	10/21/2024	In vitro studies takes {{c1:: 2 years}}
Published	10/21/2024	Animal testing takes {{c1:: 2 years}}
Published	10/21/2024	Clinical testing takes {{c1:: 4 to 5 years}}
Published	10/21/2024	New Drug Application takes {{c1:: 1 year}}
Status	Last Update	Fields