Services

Histology

Pharmacology

Medical Device Testing

In Vitro Screening

Animal Model Development

Custom Assay Development

Vivarium Rental

Toxicology

Species

Non-human Primates

Dogs

Mini-Pigs / Pigs

Rabbits

Mice

Rats

Sheep

Guinea Pigs

Hamsters

Other Species

Therapeutic Areas

Oncology

Immunology & Inflammation

Neurology / CNS

Cardiovascular

Dermatology & Wound Healing

Metabolism

Gastroenterology

Hepatology

Pulmonology

Infectious Diseases & Sepsis

Musculoskeletal

Nephrology & Urology

Capabilities

GLP / IND-Enabling Studies

Small and Large Animal Housing

Bioanalytical Platforms

About

News

Contact

Career

Request a Quote

☰

Rabbit Studies

Key to an Exhaustive Safety Profile

The rabbit model is an indispensable component of many regulatory submissions, providing critical safety data where its unique physiology is especially predictive and translatable. BioLegacy’s deep expertise in GLP and non-GLP rabbit studies ensure rich and conclusive data generation in developmental and reproductive toxicology (DART) and dermal safety, as well as in atherosclerosis studies. Whether you need to optimize your leads or generate submission-ready data required for IND, BioLegacy will efficiently and effectively de-risk your program.

  • GLP-Compliant DART Studies: ICH S5(R3)-compliant embryo-fetal development (EFD) toxicity studies, a critical component for most IND submissions.
  • Dermal Safety & Irritation: Robust models for assessing the safety, irritation, and sensitization potential of topical and transdermal therapeutics.
  • Atherosclerosis & Hyperlipidemia Models: Well-established, diet-induced models that provide a rapid, cost-effective system for evaluating cardiovascular therapeutics.
  • Medical Device & Biocompatibility Testing: ISO 10993 biocompatibility tests and evaluation of orthopedic or soft tissue implants.
  • Comprehensive Bioanalytical & Pathology Support: Fully integrated in-house services for PK/TK sample analysis and expert pathological interpretation of study endpoints.
Developmental and Reproductive Toxicology (DART) Studies

The unique teratogenic sensitivity of the rabbit model makes it the essential, regulatory-mandated non-rodent species for developmental and reproductive toxicology (DART) studies. BioLegacy’s GLP-compliant DART studies meet the rigorous ICH S5(R3) guidelines for assessing potential effects on embryo-fetal development. By leveraging this extensively validated and highly predictive system, we deliver unambiguous safety data to characterize the risk profile of your therapeutic and confidently support your IND submission.

  • ICH S5(R3)-Compliant EFD Studies: Gold-standard embryo-fetal development studies to assess teratogenic potential.
  • Expert Maternal & Fetal Assessments: In-depth evaluation of maternal toxicity and detailed fetal external, visceral, and skeletal examinations.
  • Integrated TK Analysis to establish clear maternal and fetal exposure relationships.
  • Dose Range-Finding (DRF): Precise preliminary studies to select appropriate dose levels for the pivotal DART study.
  • Full Regulatory-Ready Reporting: Comprehensive, audited final reports. Optional SEND datasets formatted for global submission (in collaboration with our partners).
Dermal Safety Studies

Characterizing the local tolerance and sensitization potential of a topical therapeutic is a critical step in any dermatology program. At BioLegacy, we utilize the highly sensitive rabbit model to provide critical early assessments of your compound’s dermal safety profile (pigs are preferred for GLP dermal safety studies). Our expertise in conducting these specialized studies, from acute irritation to immunogenic sensitization, cost-effectively delivers the clear, quantitative data necessary for understanding potential human reactions and de-risking your pipeline in advance of further studies.

  • Validated models to assess erythema and edema for acute local tolerance. Primary Dermal Irritation Studies:
  • Dermal Sensitization Assays: Robust models to evaluate the potential for delayed-contact hypersensitivity.
  • Quantitative Histopathology of Skin: In-house pathology to analyze inflammatory infiltrates and epidermal changes.
  • Support for GLP & Non-GLP Programs: Flexible study designs for both exploratory and regulatory-driven safety assessment.
Atherosclerosis & Hyperlipidemia Studies

The rabbit’s unique sensitivity to dietary cholesterol provides a rapid and highly translatable system for modeling the complete atherosclerotic cascade. BioLegacy leverages this well-established model to rigorously evaluate the efficacy of novel anti-atherosclerotic and lipid-lowering therapeutics. By inducing robust hypercholesterolemia and subsequent atherogenesis, our model provides a robust, quantitative assessment of your compound’s ability to inhibit plaque formation and promote vascular health.

  • Diet-Induced Hypercholesterolemia: Validated high-cholesterol diet protocols to reliably induce a human-relevant disease state.
  • Quantitative Aortic Plaque Analysis: Precise en face analysis of atherosclerotic lesion area in the aortic arch and thoracic aorta.
  • Comprehensive Lipid Panel Analysis: In-house measurement of total cholesterol, HDL, LDL, and triglycerides.
  • Advanced Histopathological Evaluation: Expert analysis of plaque composition and morphology in key vascular tissues.
  • Accelerated Study Timelines: A cost-effective and rapid model for generating pivotal proof-of-concept efficacy data.
De-Risk Your Pipeline!

From critical early assessments to GLP DART, BioLegacy’s rabbit studies will confidently advance your program.

  • GLP-compliant, IND-enabling studies
  • New, state-of-the-art vivarium
  • Hundreds of animal models
  • AAALAC-accredited facilities
  • Study initiation in under 2 weeks!

Tell us your study needs. Contact us today.