Notes in 06. Drug Development Process

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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
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