Profile toxicology

Lewis DFV. Structural characteristics of human P450s involved in drug metabolism QSARs and lipophilicity profiles. Toxicology 2000 144 197-203. 

Dearman, R.J. et al., Chemical allergy considerations for the practical application of cytokine profiling, Toxicological Sciences, 71, 137, 2003. 

S., Martin, K., DiSorbo, O., Sieber, S., Bennett, L., Tennant, R., Stoll, R., Barrett, J.C., Blanchard, K., Paules, R.S. and Afshari, C.A. (2002) Gene expression analysis reveals chemical specific profiles. Toxicological Sciences, 67, 219-231. 

Kilk K, Mahlapuu R, Soomets U, Langel U (2009) Analysis of in vitro toxicity of five cell-penetrating peptides by metabolic profiling. Toxicology 265(3) 87-95... 

Characterization of the reference standard for purity, impurities, physical-chemical properties related to bioavailability Rationale for selection of polymorphic and salt form, if applicable Batch profile—toxicology and clinical batches... 

A toxicological Profile for PCBs, Draft for PubUc Comment, was released in December 1998. This edition supercedes any previously released draft or final profile. Toxicological profiles are revised and republished as necessary, but no less than once every three years. 

Scheme 12.2). For this reason, revalidation of the API impurity profile, toxicology, and other pharmacological and regulatory issues would be required. Because this option was identified late in the chemical development process, it was decided that the potential process benefits would be more than offset by the additional efforts required to requalify the alternative process, and this option was eliminated from further commercial consideration. 

Waring, J. E., R. A. Jolly, R. Ciurlionis, P. Lum, J. T. Praestgaard, D. C. Morfitt, B. Buratto, C. Roberts, E. Schadt, and R. G. Ulrich. 2001. Clustering of hepatotoxins based on mechanism of toxicity using gene expression profiles. Toxicology and Applied Pharmacology 175 28-42. 

Hamadeh HK, Bushel PR, Jayadev S et al. 2002. Gene expression analysis reveals chemical-specific profiles. Toxicological Sciences 67(2) 219-231. 

In the United States, new dmg applications must be submitted to the Food and Dmg Administration (FDA), together with the appropriate chemical, manufacturing and control data, such as methods and specifications, the results of stability tests, proper labelling, details of pharmacological activity, the pharmacokinetic profile, toxicology studies and impurity limits [14]. In 1987, for the first time, the FDA published a set of guidelines on the submission of new chiral dmg applications. Each new dmg submission should show the molecular stmcture and the chiral centres of the dmg. The FDA also emphasizes the need for toxicological studies for each... 

Sayes, C.M., Reed, K.L., Warheit, D.B., 2007. Assessing toxicity of fine and nanoparticles Comparing in vitro measurements to in vivo pulmonary toxicity profiles. Toxicological Sciences 97 (1), 163-180. 

Monomers containing reactive functional groups ia the ester moiety exhibit the toxicological profile of the functional group and should be considered on an iadividual basis. Consideration of methods of monomer manufacture may be appropriate, as by-products, even at trace levels, may affect the observed biological response. 

W. J. Hayes, Jr., and E. R. Laws, Jr., eds.. Handbook of Pesticide Toxicology, Academic Press, Inc., San Diego, Calif., 1990. Three volume set provides detailed toxicological profiles of more than 250 insecticides, herbicides, and fungicides each compound described by identity, properties, and uses toxicity to humans, laboratory animals, domestic animals, and wildlife includes comprehensive coverage of diagnosis, treatment, prevention of injury, effects on domestic animals, wildlife, and humans - ISjOOO references. 

Extension Toxicology Network, EXTOXNET, 2nd ed., available in hard copy and electronic form from Resource Center, Cornell University, Ithaca, N.Y., 1994. Contains 139 pesticide information profiles (PIPs), 16 toxicology information briefs (TIBS), and other information on current issues in pesticide toxicology and environmental chemistry. 

Agency for Toxic Substances and Disease Registry, Toxicological Profile forBen yene, U.S. Department of Commerce, Adanta, Ga., May 1989. 

Asoc inol. Asocainol, a diben2azonine derivative, has sodium channel (Class I) and calcium channel (Class IV) blocking activity that accounts for the antiarrhythmic activity. Preliminary studies indicate that the compound is effective against ventricular arrhythmias (88). Additional studies are needed to estabUsh efficacy, toxicological potential, and pharmacokinetic profile. 

Health Effects Assessment for Hexavalent Chromium, EPA/540/1-86-019, United States Environmental Protection Agency (EPA), Sept. 1984 Toxicological Profile for Chromium, Agency for Toxic Substances and Disease Registry (ASTDR), ASTDR/TP-88/10,1989. 

Toxicity Profile—Cyclohexanone, BIBRA Toxicology International, The British Industrial Biological Research Association, Carshalton, Surrey, UK, 1987. 

ATSDR s Toxicological Profiles on compact disc. (Lewis Publishers, 1997 CRC Press, Inc.). 

The pharmacological activities of the isomers should be compared in vitro and in vivo in both animals and humans. Separate toxicological evaluation of the enantiomers would not usually be required when the profile of the racemate was relatively benign but unexpected effects - especially if unusual or near-effective doses in animals or near planned human exposure - would warrant further studies with the individual isomers. 

Toxicology ( toxicogenomics), to identify potential human and environmental toxicants, and to find correlations between toxic responses to toxicants and changes in the genetic profiles of the objects exposed to such toxicants... 

Toxicology Many companies are known to use gene expression profiling to assess the potential toxicity of lead compounds. This approach may require a database of reference compounds with known pharmacological and toxicological properties. Lead compounds can be compared to the database to predict compound-related or mechanism-related toxicity [5]. 

Considerable studies are required to establish the toxicological profile of the drug substance. These must assess its direct toxic effects, together with its potential as a reproductive toxin, mutagen, or carcinogen. 

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