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Gad Consulting Services has evaluated thousands of molecules for human and animal toxicity and compliance with regulatory standards. We have evaluated drug candidate molecules, marketed drugs, impurities, process intermediates, degradents, leachables, excipients, residual solvents, and extractables. Both known and unknown compounds can be evaluated using a combination of full literature searches (for known molecules), QSAR (Quantitative Structure-Activity Relationship) evaluations (for novel compounds), searches of both public and proprietary databases, and our extensive experience with compound toxicity evaluation.
Services
- Evaluation of both known and novel compounds
- Screening for developmental candidates ("Fail Early, Fail Economically" model)
- Calculation of safe and allowable levels and qualification of process impurities, residual solvents, degradents, and excipients
- Design of further safety testing based on known or predicted toxicology
- Indentification of compounds of regulatory concern
- Assessment of the potential hazard of batch-to-batch or scale-up changes in drug composition
- Estimation of the risk from leachables and extractables
- Answering regulatory questions and concerns for both active and inactive compounds
- Pharmaceutical active ingredient occupational / manufacturing hazard categorization
- Impurities qualification for pesticides as per FAO/WHO (international)
Information Sources
- Derek (Lhasa, Ltd.)
- Assessment of risk levels in both humans and animals using QSAR methods
- Accepted as a predictive model by the FDA
- Prediction of multiple toxicity endpoints: carcinogenicity, chromosome damage, genotoxicity, hepatotoxicity, HERG channel inhibition, irritation, mutagenicity, ocular toxicity, reproductive toxicity, respiratory sensitization, skin sensitization, thyroid toxicity, and other miscellaneous or custom endpoints
- Estimation of safety testing outcomes (e.g. Ames, CHO, etc.)
- High-throughput screening for all assessed endpoints
- Meteor (Lhasa, Ltd.)
- Predicted metabolites for drugs, impurities, degradants, or any other compound
- Estimation of metabolic pathways and their likelihood
- Recursive evaluation for estimation of full metabolic tree
- STN
- STN is a multiple-database search service from CAS, a division of the American Chemical Society
- Includes RTECS, HSDB, TOXCENTER, AGRICOLA, BIOSIS, BIOTECHNO, DDFB, DDFU, DISSABS, DRUGB, DRUGU, EMBAL, EMBASE, ESBIOBASE, HEALSAFE, IMSDRUGNEWS, LIFESCHI, MEDLINE, MSDS-CCOHS, MSDS-OHS, PHARMAML, SCISEARCH, TOXCENTER, VETB, and VETU.
- Structure searches using multiple criteria
- Leadscope Enterprise
- Full search of published FDA data on marketed drugs, excipients, and food chemicals
- Full search of multiple other FDA databases: FDA SAR Carcinogenicity Database, FDA SAR Genetox Database, FDA CDER 2011 Chronic/Subchronic Database, FDA CDER (Center for Drug Evaluation and Research) reviews, FDA CDER 2011 Genetox Database, FDA CDER 2011 Repro-Developmental Database, FDA CFSAN 2011 Acute Toxicity Database, FDA CFSAN 2011 Chronic/Subchronic Database, FDA CFSAN 2011 Genetox Database, and the FDA CFSAN 2011 Repro-Developmental Database
- Toxicity data for more than 163,000 chemical structures (data primarily from RTECS)
- Predictive toxicology using structural similarity searches
- Leadscope Model Applier
- Compound assessment using the QSAR models that the FDA uses for predictive toxicology (models under development may not be available)
- Prediction of rodent carcinogenicity, non-human genetic toxicity, non-human reproductive toxicity, non-human developmental toxicity, non-human neurotoxicity, non-human miscellaneous toxicity endpoints, human adverse hepatobiliary effects, and human adverse urinary tract effects
- Literature, Databases, and Experience
- Gad Consulting Services initiated and continues to update the vehicles project to identify safe levels of vehicles and excipients for nonclinical studies.
- GCS has experienced researchers with access to both public and fee-based toxicology, medical device, biomaterial, chemical, and biochemical databases.
- We have licensed copies of mutiple chemical entity search programsand a vast library, including the Merck Index, USP, Martindale's, PDR, an excipient database, and other similar products.
- Gad Consulting Services has internal databases of evaluated drugs, excipients, polymers, and biomaterials.
- Extensive library access: NLM, universities, publishers and internet journals holdings.
- In addition, Dr. Gad has authored or edited 44 books, 52 independent chapters and more than 400 papers and abstracts and has more than 34 years of experience in compound risk assessment.
Contact GCS for more information.
Last Updated December 19, 2011
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