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  2. Drug development - Wikipedia

    en.wikipedia.org/wiki/Drug_development

    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.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 ...

  3. Phases of clinical research - Wikipedia

    en.wikipedia.org/wiki/Phases_of_clinical_research

    For drug development, the clinical phases start with testing for drug safety in a few human subjects, then expand to many study participants (potentially tens of thousands) to determine if the treatment is effective. [1] Clinical research is conducted on drug candidates, vaccine candidates, new medical devices, and new diagnostic assays.

  4. Drug pipeline - Wikipedia

    en.wikipedia.org/wiki/Drug_pipeline

    The drug pipeline is also sometimes restricted to a particular drug class or extended to mean the process of discovering drugs (the research and development pipeline). [3] The R&D pipeline involves various phases that can broadly be grouped in 4 stages: discovery, pre-clinical, clinical trials and marketing (or post-approval).

  5. Preclinical development - Wikipedia

    en.wikipedia.org/wiki/Preclinical_development

    In drug development, preclinical development (also termed preclinical studies or nonclinical studies) is a stage of research that begins before clinical trials (testing in humans) and during which important feasibility, iterative testing and drug safety data are collected, typically in laboratory animals.

  6. Drug discovery - Wikipedia

    en.wikipedia.org/wiki/Drug_discovery

    In the fields of medicine, biotechnology, and pharmacology, drug discovery is the process by which new candidate medications are discovered. [1] Historically, drugs were discovered by identifying the active ingredient from traditional remedies or by serendipitous discovery, as with penicillin.

  7. Pharmaceutical formulation - Wikipedia

    en.wikipedia.org/wiki/Pharmaceutical_formulation

    By the time phase III clinical trials are reached, the formulation of the drug should have been developed to be close to the preparation that will ultimately be used in the market. A knowledge of stability is essential by this stage, and conditions must have been developed to ensure that the drug is stable in the preparation.

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  9. Hit to lead - Wikipedia

    en.wikipedia.org/wiki/Hit_to_lead

    Hit to lead (H2L) also known as lead generation is a stage in early drug discovery where small molecule hits from a high throughput screen (HTS) are evaluated and undergo limited optimization to identify promising lead compounds.