PIVOTAL TOXICOLOGY STUDIES
Leveraging extensive expertise and state-of-the-art facilities, Altasciences conducts comprehensive toxicology evaluations to ensure the safety and regulatory compliance of your novel therapeutics.
EXPERT-LED TOXICOLOGY STUDIES
Altasciences combines a team of toxicologists, pathologists, veterinarians, study directors, and regulatory specialists to conduct in-depth GLP and non-GLP studies. Our expertise in rodent and non-rodent species ensures thorough safety evaluation for upcoming first-in-human trials in healthy normal volunteers, patients, and special populations.
To delve deeper into how our toxicology studies can specifically support your project's safety assessment needs, feel free to connect with us. Our knowledgeable team is ready to answer your questions and guide you through our comprehensive process.
STATE-OF-THE-ART FACILITIES AND GLOBAL COMPLIANCE
Our cutting-edge, AAALAC accredited facilities house diverse species in custom-designed rooms. Our in-house bioanalytical laboratories and Good Laboratory Practices (GLPs) ensure study alignment with international regulatory standards. Recognized globally, our protocols support safety assessments for a wide range of patient groups, facilitating first-in-human trials and beyond.
Your pivotal toxicology studies with Altasciences bring several key benefits:
- experienced management teams from pharma, biotech, and CRO backgrounds;
- expertise in both rodent and non-rodent species;
- proficiency in safety testing for small and large molecules; and
- over 25 years of quality assurance leadership.
Our toxicity and carcinogenicity studies are performed in full compliance with GLPs. We prepare SEND-ready datasets for seamless submissions to global regulatory agencies. All protocols are designed to meet the specific regulatory requirements of the countries where the products will be used in clinical trials or commercialized. Our scientific reports are recognized by government agencies across North America, Europe, and Japan.
We have four strategically located state-of-the-art preclinical facilities throughout North America with:
- 280 specialized animal rooms, including North American and European housing;
- capacity to house numerous species: approximately 4,020 NHPs, 1,550 canines, 1,150 swine, 20,800 rodents, 1,700 rabbits, 300 guinea pigs; and
- fully-equipped in-house bioanalytical laboratories.
WEBINAR―Watch our webinar led by Julie Forget, Director of Safety Assessment a Altasciences. With over 15 years in the preclinical industry, Julie offers deep insights on interpreting nonclinical toxicity study data. The webinar delves into case studies on overt toxicity, exaggerated pharmacology, and marker changes, providing strategies to differentiate adverse from non-adverse effects.
TOXICOLOGY STUDY DESIGNS AND SAFETY TESTING SERVICES
Altasciences' pivotal toxicology study designs can range from acute to two-year duration, and include an array of safety testing services. Our supporting capabilities extend to formulation, bioanalysis, clinical pathology, and more, ensuring meticulous and comprehensive study support.
Safety Testing Services
- Single-dose studies
- Dose range finding studies
- Sub-chronic dosing studies
- Chronic dosing studies
- Carcinogenicity studies
- Safety pharmacology studies
- Genetic toxicology
Supporting Capabilities
- Formulation
- Analytical chemistry, dose formulation analysis
- Bioanalysis
- PK/TK data analysis
- Clinical pathology
- Flow cytometry, cytokine, and biomarker analysis
- PCR
- Anatomic pathology
- Immunohistochemistry
- Biodistribution
- SEND
WIDE RANGE OF SPECIES AND ADMINISTRATION METHODS
Our facilities accommodate a diverse range of species, including rats, dogs, and nonhuman primates. Our technicians provide varied routes of administration, from oral to intravaginal, tailoring studies to your specific needs.
Species
- Rats
- Mice
- Guinea pigs
- Rabbits
- Swine
- Miniature swine
- Dogs
- Nonhuman primates
(Cynomolgus, Rhesus, others upon request)
Routes of Administration
- Oral
- Parental
- Infusion
- Ocular
- Dermal
- Implant
- Intravaginal and intrapenile
- Rectal
WEBINAR―Discover crucial insights into species selection for nonclinical programs in this webinar led by our experts Andrew G. Taylor and Scott E. Boley, as they explore the impact of compound metabolism on species justification and program design. Learn about the scientific rationale behind species selection, the importance of in vitro species comparison studies, and key considerations for rodent and non-rodent species choices.
Altasciences’ pivotal toxicology studies contribute to a systematic and well-informed drug development process. They enable researchers to make data-driven decisions, reducing the likelihood of unexpected safety issues in later stages of clinical development.
PIVOTAL TOXICOLOGY STUDIES―FAQs
What are the benefits of toxicology studies?
BENEFITS OF TOXICOLOGY STUDIES
Safety Assessment―They help identify potential adverse effects, determine dose-dependent responses, and establish safety margins. This information is crucial for subsequent clinical trials.
Dose Selection―They help to understand the dose-response relationship and aid in selecting the appropriate doses for upcoming clinical trials.
Risk Mitigation―Identifying and characterizing potential toxicities early in the drug development process enables educated risk assessment and mitigation techniques. This may entail changing dosages, putting monitoring systems in place, or stopping the development of a specific compound.
Ethical Considerations―These studies provide essential preliminary data and a better understanding of the safety profile of a drug, allowing researchers to make more informed decisions before exposing humans to potential risks.
Data Labeling and Informed Consent―The safety information on pharmaceutical labels is formulated in part by the findings of pivotal toxicology studies, allowing patients and medical professionals to make educated decisions and give their informed consent for clinical trials.
Resource Allocation―By identifying safety concerns early in the drug development process, you can avoid allocating resources to the development of compounds with poor safety profiles and allocate funds to more promising drug candidates.
OUR FULL SPECTRUM OF PRECLINICAL SERVICES
Dive deeper in Altasciences' extensive range of preclinical services. From early phase development to clinical trial readiness, our comprehensive offering ensures a seamless transition through each stage of drug development.