IND, Investigation New Drug application

IND Investigational New Drug application, filed with FDA after preclinical testing is complete asking for permission to proceed with human tests. 

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).

IND Investigational New Drug. Application must be approved by the Food and Drug Administration (FDA) before a drug can be tested in humans in clinical trials. 

Figure 2.7. Studies requiring bioanalytical quantitation during drug discovery and development. (GLP, Good laboratory practices IND, Investigational new drug application.)...

BLA—Biologies License Application (eCTD and eBLA format) eCTD—Electronic Common Technical Document IDE—Investigational Device Exemption IND—Investigational New Drug Application (eCTD and eIND format)... 

IND—Investigational New Drug Application CDRH Adverse Events... 

Phases in the development of a biopharmaceutical and the concept of time-to-market. IND, Investigational New Drug Application BLA, Biologies License Application (adapted from Werner, 2004). 

ADME—Absorption, Distribution, Metabolism, Excretion IND—Investigational New Drug application NDA—New Drug Application... 

KEY IND investigational new drug application NA - not available NDA- new drug application. 

In the US, an IND (Investigational New Drug) application has to be filed with the FDA. For other countries, a notification has to be submitted to the respective regulatory authorities. For example, Clinical Trial Exemption (CTX) applications are required for the UK, Clinical Trial Notification (CTN) and CTX for Australia, and a Clinical Trial Certificate (CTC) for Singapore and the European Agency for the Evaluation of Medicinal Products (EMEA). A more extensive discussion concerning regulatory authorities and the processes and procedures of applications is presented in Chapters 7 and 8. The relevant authority will review the application. A positive response from the authority is required before the trial can commence. 

IND. Investigation New Drug application. The application to the FDA, based on pre-cllnlcal results, for permission to begin testing a pharmaceutical in humans. 

Requests for permission to conduct clinical trials with pharmaceuticals in the US are termed Investigational New Drug Applications (INDs). The applications are actually a request for an exemption to supply a drug without a marketing authorisation. A cover sheet (Form 1571) must accompany the application. This cover sheet should also be used with each subsequent communication with the FDA, with each form consecutively numbered, starting at 000 for the initial submission. A copy of the form is shovm in Figure 5.6. 

Investigational New Drug Applications (INDs), NDAs, Premarket Approval Applications (PMAs), Premarket Notifications (5 lO(k)s), Investigational Device Exemptions (IDEs), Biological Master Files (BMFs) and DMFs that are referenced in the current application. 

Lumpkin, M. (1996). Guidance for Industry Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including well-characterized, therapeutic, and biotechnology-derived products, http //www.fda.gov/cder/guidance/phasel.pdf... 

Note GLP = Good Laboratory Practice ICH = International Conference on Harmonization IND = Investigational New Drug JMHW = Japanese Ministry of Health and Welfare MAA = Marketing Authorization Application NCE = New Chemical Entity. 

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