title: Overview of drug discovery and development.
abstract: This overview unit describes the core activities involved in the drug discovery and development process, from target identification - including preclinical biology, medicinal and process chemistry - to pharmacokinetics and metabolism (ADME), and also activities related to the to the drug approval process. The latter include the activities related to the filing of an IND (Investigational New Drug) application and also Phases I - III of clinical trials that form the basis of an NDA (New Drug Application) submission, as well as post-marketing Phase IV activities as required by the U.S. Food and Drug Administration (FDA) and the European and Japanese counterparts.
authors.affiliation: Cephalon, Inc., West Chester, Pennsylvania, USA.
authors.forename: Mark A
authors.initials: MA
authors.lastname: Ator
authors.forename: John P
authors.initials: JP
authors.lastname: Mallamo
authors.forename: Michael
authors.initials: M
authors.lastname: Williams
mesh_terms: D001688:Biological Products / Q000737:chemistry; D002626:Chemistry, Pharmaceutical / Q000379:methods; D003201:Computers; D017277:Drug Approval; D055808:Drug Discovery / Q000379:methods*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000517:prevention & control; D006801:Humans; D008024:Ligands; D050479:Neurotransmitter Transport Proteins / Q000037:antagonists & inhibitors; D004364:Pharmaceutical Preparations / Q000138:chemical synthesis* / Q000378:metabolism; D010599:Pharmacokinetics; D010601:Pharmacology, Clinical / Q000379:methods*; D034622:RNA Interference / Q000502:physiology; D011955:Receptors, Drug / Q000187:drug effects; D013329:Structure-Activity Relationship
chemical_list: D001688:Biological Products; D008024:Ligands; D050479:Neurotransmitter Transport Proteins; D004364:Pharmaceutical Preparations; D011955:Receptors, Drug