Notes in PHAR117 Jasti L02

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Published	10/04/2023	An NCE is a {{c1::pharmacologically active ingredient that has never before been marketed in the United States in any form.}}{{c2::Safety and efficacy…
Published	10/04/2023	Definition of Biologics
Published	10/04/2023	Pathways for Drug Approval include two methods according to CFR Title 21:{{c1::505(b)(1)}}{{c2::Stand alone NDA with full reports of safety and effica…
Published	10/04/2023	Different scenarios for FDA Approval{{c1::Change in shape of a dosage form (e.g. different shape of pill for example)}}{{c2::Change in dosage form (e.…
Published	10/04/2023	A lot of drugs are discovered throughout time, but very few get {{c1::FDA approved}}.
Published	10/04/2023	The Drug Discovery and Development process is a progression from:{{c1::Targets and Leads}} --> {{c2::Drugs}} --> {{c3::Products}}
Published	10/04/2023	Sources of New Drugs:{{c1::Chemical Synthesis}}{{c2::Natural Products}}PlantsReserpine {{c3::from Rauwolfia}}Vincristine {{c3::from Vinca}}T…
Published	10/04/2023	Developing (more specific) New Drugs:{{c1::Identify Broad disease category}}e.g. Cancer, Cardiovascular{{c2::Identify Specific disease state}}e.g. Bre…
Published	10/04/2023
Published	10/04/2023	Target Validation - Linking Targets to Diseases and Treatments{{c1::Target validation}} is: {{c2::a series of activities, aimed to build confidence th…
Published	10/04/2023	Pre-Clinical Studies Terms{{c1::In vitro test}} {{c2::(Test tube)}} {{c3::Ex vivo test}} {{c4::(Animal tissue/organ)}} {{c4::In vivo test}}&…
Published	10/04/2023	{{c1::Disposition}} is {{c2::non-specific drug exposure to normal tissues}}which can cause {{c2::unwanted side effects}}e.g. cancer therapy (chemo){{c…
Published	10/04/2023	Passage of Orally-Administered DrugADME stands for{{c1::Absorption}}{{c2::Distribution}}{{c3::Metabolism}}{{c4::Excretion}}
Published	10/04/2023	Passage of Orally-Administered Drug:{{c1::Drug is orally administered and absorbed}}{{c2::Drug passes down the gut lumendrug is partially-absorbed her…
Published	10/04/2023	Three Major Questions Upon Which Pre-Clinical Decisions are Made{{c1::Will the compound be safe when given to human subjects/patients?Demonstrate ex-v…
Published	10/04/2023	Animal Models Used in Pre-Clinical Safety Assessment (Type of Assessment, Animals Used, Additional Comments){{c1::General Toxicity}}Rodent (rat, mouse…
Published	10/04/2023	Specific Goals of Preclinical Toxicology/Pathology Studies{{c1::Define toxic dosages in animals to help select phase I dosages}}NOEL{{c2::No Obse…
Published	10/04/2023	What is the Therapeutic Index (TI)?Therapuetic Index (TI) = {{c1::Toxic Dose/Effective Dose }}The MOS {{c2::(margin of safety)}} is the {{c3::rat…
Published	10/04/2023	Types of Toxicology Studies{{c1::Acute}}{{c2::SubChronic to Chronic (repeat doses)}}{{c3::2}} species {{c3::(rodent and non-rodent) generally rat &amp…
Published	10/04/2023
Published	10/04/2023	Dosage Form DevelopmentPhysical and chemical characteristics{{c1::M. P.SolubilitypKa}}{{c2::partition coefficientphysical formdissolutionstability}}{{…
Published	10/04/2023	Drug Development Process - New Chemical Entities{{c1::Preclinical Studies}}{{c2::Investigational New Drug Application (IND)}}{{c3::Phase IPhase I…
Published	10/04/2023
Published	10/04/2023	Everyone's Responsibility with DrugsFDA{{c1::evaluates the benefits/risks for the population}}Provider{{c2::evaluates benefits/risks for a patient}}Pa…
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