Services: Toxicology Study Design and Management

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Our Nonclinical Safety Development experts conducted or monitored more than 290 toxicology studies over the past five years in both rodent and nonrodent species using several routes of administration including intravenous, oral, inhalation, dermal, intrathecal, intraperitoneal, and subcutaneous. The types of toxicology studies conducted/monitored include but are not limited to: absorption, distribution, metabolism, and excretion (ADME); safety pharmacology; single and repeated dose toxicology; carcinogenicity; genotoxicity; developmental and reproductive toxicology; immunotoxicology; special toxicology; and biocompatibility studies. The table below summarizes the cumulative number of studies that our toxicologists have worked on as Study Directors or consultants since 1998.

Study Type Rodents   Non-Rodents   In
Vitro
IV PO SC INH Oth IV PO SC INH Oth
Safety Pharmacology 7 12 - 4 - 11 9 - 2 - -
PK/ADME 7 13 - 1 20 7 21 1 1 14 9
Single Dose/Pilot Study 15 28 2 10 3 14 22 1 7 2 -
Repeated Dose (14D-3M) 12 27 3 12 4 10 19 2 10 6 -
Repeated Dose (5-12M) - 9 2 2 1 12 11 2 1 7 -
Carcinogenicity/Genotox - 5 1 - - - N/A N/A N/A N/A 19
DART 5 9 1 1 - 4 8 - - - -
Special Toxicology - 3 1 - - 1 2 - - 1 5
Vaccines - - 2 3 8 - - 2 - 4 -
SUB TOTAL 46 106 12 33 36 59 92 8 21 34 33
TOTAL 233 214   33
GRAND TOTAL 447
 
IV= Intravenous; PO= Oral; SC= Subcutaneous; INH= Inhalation; PK/ADME= Pharmacokinetic/Absorption, Distribution, Metabolism and Excretion; DART= Developmental and Reproductive Toxicology; N/A= Not Applicable

Experimental Toxicology Services

As a contract research and drug development consulting firm, Cato Research does not have any facilities or toxicology laboratory space to conduct animal work. Indeed, the nonclinical studies are always contracted out to qualified animal laboratories. The absence of any alliances or preferred-provider agreement with any laboratory allows us to objectively provide you with the laboratory services that best suit your needs.

The selection of a laboratory that will ultimately be responsible for conducting an entire toxicology program initially necessitates a lot of meticulous work and is often an area that is rapidly neglected, especially when staff is overburdened with other tasks. On many occasions, people confronted with a very busy schedule will tend to take short cuts when it comes to toxicology laboratory selection and therefore end up making decisions based on questionable criteria. Our toxicologists dedicate themselves to setting up, implementing and ensuring the smooth progress of the nonclinical safety programs. They are frequently involved in managing nonclinical programs and can provide the following services:

  • Contacting CROs to request price quotations, negotiating costs, and setting up details for the contractual agreement between the CRO and the Sponsor;
  • Designing, reviewing and implementing nonclinical study protocols to ensure that they fulfill our sponsor's needs and regulatory requirements;
  • Streamlining study schedules to optimize the nonclinical program;
  • Monitoring nonclinical studies, especially critical steps of each study, to assure compliance to Good Laboratory Practice regulations (GLP) and toxicology CRO internal standard operating procedures (SOPs);
  • Acting as the main contact for technical and scientific toxicology issues raised during the conduct of the study;
  • Reviewing and finalizing nonclinical audited study reports in a timely fashion for inclusion into regulatory submission(s).

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