Entry into humans

Kaul D, Anand PK, Verma I. Cholesterol-sensor initiates M. tuberculosis entry into human macrophages. Mol Cell Biochem 2004 258(l-2) 219-222. 

Dingemanse J, Clozel M, van Giersbergen PL. Entry-into-humans study with tezosentan, an intravenous dual endothelin receptor antagonist. J Cardiovasc Pharmacol 2002 39(6) 795-802. 

Budde K, Winkler M, et al. Entry-into-human study with the novel immunosuppressant SDZ RAD in stable renal transplant recipients, J Clin Pharmacol 1999 48 694-703.. ... 

Analytical documentation requirements during the life cycle of a pharmaceutical product—from initial candidate screening and selection, through entry into humans/IND, to NDA and postapproval marketed product support—are discussed in this book. Most of the information is based on US FDA and ICFF guidelines EU requirements are not substantially different. 

C. Phase 0 Preclinical Development/Pre-entry into Humans... 

FIGURE I Life cycle for new drug development. EIH, entry into humans FDDP, full development decision point. 

HHV-8 (7 herpesvirus), also called KSHV or KSVH vMIPI MIP-la (38.0% identity) Blocks HIV-1 entry into human mononuclear cells Strongly angiogenic in CAM. Infects Kaposi s sarcomas... 

Of the many rentes of toxic-material entry into humans, inhalation is the most likely to occur and is the rente specified in cnrrent legislation. Toxicity data have been developed for most of the important indnstrial chemicals [19] and form the basis for threshold or allowable concentrations to which persons cam be exposed with no significant physiological effect. Evaluation of toxicity hazards is then based on the duration of exposures to concentrations above these threshold levels. The concentrations of toxic materials in air are primarily functions of vapor pressure and temperature (for toxic liquids) the rate of gas, vapor, mist, or dust release or generation and distance from the source. 

Prokesch, R. C., and Hand, W. L. (1982). Antibiotic entry into human polymorphonuclear leukocytes. Antimicrob. Agents Chemother. 21, 373—380. 

Benzidine is a known carcinogen, causing bladder cancer in humans. Numerous reports in the literature document its carcinogenicity in animals and humans. Oral or subcutaneous application of this compound in experimental animals produced tumors in liver, blood, lungs, and skin. The routes of entry into human body are primarily the inhalation of... 

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