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Determine volume of distribution, half-life and clearance from concentration-time data, apply in vitro ADME assays, and use PK/PD relationships to predict human dose and select compounds.
Learn to run trials under ICH Good Clinical Practice: protect participant safety, prepare sites and personnel, recruit participants, and safeguard data integrity and regulatory compliance.
Learn the principles of Good Clinical Practice: ICH GCP guidelines, informed consent, risk and data integrity, the drug discovery process, and diversity in trial inclusion criteria.
Explore preclinical drug discovery from target identification and assay screening through lead selection and optimization, pharmacokinetics, preclinical safety, and preformulation.
Learn to recruit and enroll trial patients, run the informed consent process with vulnerable groups, and handle documentation, protocol compliance, close-out and archiving under GCP.
Learn how an investigator and site prepare to run a clinical trial: qualification criteria, site selection visits, essential documents, IRB/IEC review, ALCOA+ source data, and site staff roles.
Follow a drug from idea to candidate: survey preclinical discovery steps, target and molecule evaluation, pharmacokinetics, safety, clinical hurdles, and competitive intelligence.
Learn how active compounds become dosable formulations: route of administration, solubility enhancement, crystalline form, drug substance versus drug product, storage needs, and biologic versus small-molecule differences.
Explore early-stage drug discovery: compare target-based and phenotypic approaches, screen small-molecule libraries, design assay types, and validate that hits engage the intended target.
Learn how in vitro and in vivo toxicology studies identify drug safety risks, set a therapeutic index or safety window, and guide early human dose selection.
Follow an antimalarial discovery case study to select and optimize drug leads: screening assays, potency, efficacy, pharmacokinetics criteria, and structure-activity relationships shaping a pharmacophore.
Learn why representation in clinical trials matters: healthcare disparities, barriers and mistrust among underrepresented populations, and how conscious and unconscious bias shapes clinical research.
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