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New drug application, NDA

Application and approval process NDA (New Drug Application) PLA (Product License Application) ELA (Establishment License Application) BLA (Biologic License Application)... [Pg.16]

Fig. 1. The Pharmaceutical Pipeline. The different phases of drug development are outlined, starting with a lead compound and moving forward through preclinical and clinical testing towards market approval. (CS candidate selection IND investigational new drug application POC proof of concept NDA new drug application FTIH first time in human). Fig. 1. The Pharmaceutical Pipeline. The different phases of drug development are outlined, starting with a lead compound and moving forward through preclinical and clinical testing towards market approval. (CS candidate selection IND investigational new drug application POC proof of concept NDA new drug application FTIH first time in human).
The evidence of formal written procedures is one of the requirements of cGMP as well as the SOP stated in the Abbreviated New Drug Application (ANDA) and (NDA) New Drug Application to ensure compliance to cGMP requirements. [Pg.688]

ADME—Absorption, Distribution, Metabolism, Excretion IND—Investigational New Drug application NDA—New Drug Application... [Pg.54]

RCT randomized, controlled trial NDAs new drug applications FDA Food and Drug Administration FD C Act Food, Drug, and Cosmetic Act IND investigational new drug ADE adverse drug event... [Pg.122]

Note For Assays, Categories I and II quantitative only. NDA = New Drug Application. [Pg.229]

KEY NCE- new chemical entity NDA- new drug application NSAIDs - nonsteroidal anti-inflammatory drugs... [Pg.14]

KEY IND investigational new drug application NA - not available NDA- new drug application. [Pg.44]

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See also in sourсe #XX -- [ Pg.128 , Pg.134 , Pg.135 , Pg.136 , Pg.137 , Pg.138 , Pg.139 , Pg.140 , Pg.141 , Pg.142 , Pg.143 , Pg.144 , Pg.145 , Pg.146 , Pg.159 ]

See also in sourсe #XX -- [ Pg.192 ]



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Drugs, new

NDA

NDAs

New Drug Applications (NDAs)

New Drug Applications (NDAs)

New applications

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