Calvert Holdings

Calvert Holdings provides vision, resources, and business leadership for all of the companies it develops and acquires. Life sciences are a core competency, but not all our business endeavors are within that field. Click the links to explore our companies, or contact us for more information.
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Toxicology

We are experienced in virtually all classes of compounds, and in the safety assessment of pharmaceuticals, biotechnology products, chemicals and certain medical devices. We offer:

  • Acute Toxicology
  • Subchronic/Chronic Toxicology
  • Carcinogenicity Studies
  • Reproductive/Developmental

Studies performed to date have supported virtually every indication and pharmaceutical category in the Physician’s Desk Reference and support multiple IND-enabling programs on a yearly basis.

Safety Assessments have been conducted with several therapeutic classes of pharmaceuticals, biotechnology products and chemicals, as well as risk assessment of certain medical devices. Toxicology studies are routinely performed in the mouse, rat, guinea pig and hamster, rabbit, dog, mini-pig and non-human primate (typically sp cynomolgus).

Traditional Pharmaceutical or Biotechnology-derived Products

We collaborate with clients not only on individual study designs, but also in the design of overall non-clinical development programs to enable our clients to meet their product development goals and facilitate world-wide regulatory approval. Our toxicology group works closely with the Pharmacokinetics and Metabolism, Pharmacology/Safety Pharmacology (CNS, cardiovascular, pulmonary) and Immunology to bring our clients a multidisciplinary approach to individual study designs and overall product development programs. We specialize in conducting studies for time sensitive IND submissions.

Toxicology studies are routinely performed in rodents (mice, rats, cotton rats, guinea pigs and hamsters) and non-rodents (rabbits, dogs, mini/micro pigs, swine and non-human primates) by a variety of routes of administration including oral (gavage, capsule, diet), intravenous (bolus and infusion), dermal, ocular (topical and intravitreal), intranasal, vaginal, subcutaneous, intramuscular and intraperitoneal. In addition, we have the capability of administering test articles by less common routes such as intracavernously, intravesically, intraarticularly and intrahepaticly. We also implant some types of medical devices.

Acute Toxicology

In addition to studies that define the general single-dose toxicity profile of test articles, we also perform dermal, eye, vaginal, venous, perivenous and hamster cheek pouch irritation studies, sensitization studies, phototoxicity and photoallergy, chloracne and comedogenicity studies. Furthermore, we are skilled at measuring intraocular pressure in both acute and multiple-dose studies.

Subchronic/Chronic Toxicology

We routinely conduct our sponsor’s requirements ranging from single-dose toxicity studies, repeat-dose toxicity studies, through two-year carcinogenicity studies.

Reproductive/Developmental Toxicology

We perform studies for fertility and general reproductive performance (Segment I), embryo-fetal development or teratology (Segment II), peri- and post-natal development (Segment III), and single and multiple generation studies.

Our study directors are very involved in their studies on a daily basis, and together with other staff members and management, are readily available to assist our clients in meeting their individual study or program needs, and to provide extensive, multifaceted experience.