Toxicology Evaluation

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, degradants, and excipients
Design of further safety testing based on known or predicted toxicology
Identification 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)
Preclinical study design
Assessment of changes to manufacturing process
Design of stability studies
Recommendation of preclinical and analytical CROs
More than 1,500 successful evaluations (view List of Compounds Assessed)

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 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

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

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 multiple chemical entity search programs and 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 (view List of Compounds Assessed)
Extensive library access: NLM, universities, publishers, and internet journals holdings
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