Risk Assessment

GCS has performed numerous risk assessments and prepared comprehensive reports on (drugs, excipients, formulations, impurities, and degradants), for pharmaceutical, industrial, agricultural and environmental agents, food packaging materials, Proposition 65 filings, e-cig ingredients and materials, and medical devices.

View Partial List of Compounds Assessed

Risk Assessment

  • Calculation of safe and allowable levels and qualification of process impurities, residual solvents, degradants, and excipients
  • Estimation of the risk from leachables and extractables (TRA’s)

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
  • Application as tool for candidate selection

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 (Hosted Client)

  • 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 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.
  • In addition, Dr. Gad has authored or edited 53 books, 80 independent chapters and more than 400 papers and abstracts and has more than 47 years of experience in compound risk assessment.
  • TOXNET, OECD and ECHA