Notes in New Drug Development and Approval Process

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Status	Last Update	Fields
Published	08/15/2024	Any drug that is not recognized as being safe and effective in the conditions recommended for its use in the labeling among experts who are qualified …
Published	08/15/2024	TREATMENT IND
Published	08/15/2024	ANDA
Published	08/15/2024	SNDA
Published	08/15/2024	EUA
Published	08/15/2024	Application being filed to FDA to certain new drugs to treat serious life-threatening illness.
Published	08/15/2024	Treatment IND (Investigational New Drug) are placed on an {{c1::accelerated or fast-track program}} for approval
Published	08/15/2024	Used to gain approval to market a duplicate of a product that is already approved and being marketed by the pioneer, or the original sponsor, of the d…
Published	08/15/2024	Is filed or submitted for approval if certain changes in previously approved NDA, such as labeling or a formulation change.
Published	08/15/2024	{{c1::Orphan drugs}} are intended for the treatment of “rare diseases and conditions”.
Published	08/15/2024	Regulations for Specific Orphan Drugs
Published	08/15/2024	BLA
Published	08/15/2024	INADA
Published	08/15/2024	NADA
Published	08/15/2024	SNADA
Published	08/15/2024	Goal Drug
Published	08/15/2024	Goal drug produce the specifically {{c1::desired effect}}, be administered by the {{c2::most desired route}} at {{c3::minimal dosage}} and {{c4::dosin…
Published	08/15/2024	Methods of Drug Discovery
Published	08/15/2024	What are methods used for random/untargeted screening?
Published	08/15/2024	In-vitro assay are conducted {{c1::outside}} the membrane such as {{c2::petri dish}}
Published	08/15/2024	In vivo assays are conducted {{c1::inside}} the membrane such as {{c1::animal testing}}
Published	08/15/2024	Molecular Modification
Published	08/15/2024	Mechanism-based drug design
Published	08/15/2024	Lead compound is a _____ _____ _____ that has fundamental desired biologic or pharmacologic activity
Published	08/15/2024	Lead compound may not possess all the features desired, such as {{c1::potency, absorbability, solubility, low toxicity}} and so forth.
Published	08/15/2024	{{c1::Prodrugs}} are used to describe a compound that requires {{c2::metabolic biotransformation}} after administration to produce the desired ph…
Published	08/15/2024	Factors that are considered in designing a prodrug
Published	08/15/2024	{{c1::Pharmacology}} is the science concerned with drugs, their sources, apperance, chemistry, action and uses
Published	08/15/2024	Pharmacodynamics
Published	08/15/2024	Pharmacokinetics
Published	08/15/2024	Drug metabolism
Published	08/15/2024	Toxicology
Published	08/15/2024	Phase 1 (Clinical Trials)
Published	08/15/2024	Phase 2 (Clinical Trials)
Published	08/15/2024	Phase 3 (Clinical Trials)
Published	08/15/2024	Phase 4 (Clinical Trials)
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Status	Last Update	Fields