IND investigational new

Vaccines There are two IND (investigative new drug) human unlicensed VEE vaccines available. The first, named TC-83, developed in the 1960s is a live, attenuated cell-culture-propagated vaccine produced by the Salk Institute, and is not effective against all the serotypes in the VEE complex. It is used in a single subcutaneous dose of 0.5 mL. 

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

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. 

Is has long been the policy of the FDA to work as much as possible as a partner of the pharmaceutical industry from the submission of the IND (Investigational New Drug documentation) before the start of clinical studies until the approval of the NDA before marketing of the compound. 

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).

Figure 1 Numbers of IND applications (total and active) and pre-IND consultations in each of the New Drug Divisions in CDER. Abbreviation. IND, investigational new drug CDER, Center for Drug Evaluation and Research.

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.)...

Figure 2.10. The microdosing strategy for candidate selection offers the greatest benefit when a stop-development decision is made. This is because the exploratory IND does not forego the submission of a traditional IND to continue testing in the clinic. (IND, Investigational new drug mths, months FIH, First-in-human clinical study Ph1, Phase 1 clinical studies Ph2, Phase 2 clinical studies.)...

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... 

Abbreviations. GMP, good manufacturing practices IND, investigational new drug. 

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... 

ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use IEC Independent Ethics Committee IMP investigational medicinal product IND investigational new drug (USA)... 

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

KEY NCE- new chemical entity IND - investigational new drug FDA - U.S. Food and Drug Administration PMA- Pharmaceutical Manufacturers Association. 

KEY IND-investigational new drug NM E-new molecular entity NDA = new drug application PLA = product I icense application. 

KEY IND investigational new drug NME - new molecular entity FDA - Food and Drug Administration. SOURCE Office of Technology Assessment, 1993, based on data supplied by FDA (see appendix I). 

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