Preclinical Research
Understanding Species Variation in the Occurrence of Spontaneous Background Eye Lesions
Comparison of Cardiovascular and Respiratory Parameters in Three Strains of Research Pigs
Creation of a Swine Model of Oral Angioedema
Historical Review of In-Life Data From Studies Utilizing AAVs for Gene Therapy
Intravenous Sampling and Administration in Rodents
Proposed Best Practices for Optimizing the Number of Animals in Toxicology Studies
Drug Development for Cell and Gene Therapy
In this scientific journal, we review considerations for nonclinical cell and gene therapy development, including expert approaches to mitigating complex challenges, improving study efficiency, and maximizing translational opportunities from nonclinical to first-in-human trials.
Learn about:
• the ICH S-12 Guideline on nonclinical biodistribution studies
• species selection criteria per the FDA
• choosing the appropriate vector
• immunogenicity evaluations
• findings from two case studies
Read the issue HERE.
Ready for the next step? Contact one of our experts to discuss your study needs.
You may also be interested in the following:
• Webinar: Cell and Gene Therapy―Enhanced CNS and Ocular Delivery in NHPs
• Poster: Gene Therapy Utilizing Adeno-Associated Viral (AAV) Vectors―Historical Data Review
• Webpage: Preclinical Research Services
Development of a Novel Canine Prostatectomy Model
Mastering Drug Safety: Your Passport to Successful Pharmacology
Navigating the Depths of Safety Pharmacology
Altasciences can help you assess the impact of your therapeutic entity on vital organ systems before first-in-human trials begin. Our experts conduct the core battery of safety pharmacology tests required by international regulatory guidelines, which include cardiovascular function, respiratory function, and central nervous system behavior, as well as combined and supplemental studies, if needed.
You can expect a robust program suited to your unique needs to support your IND submission and minimize potential risks, so you can transition smoothly from preclinical to clinical pharmacology.
Explore our full range of safety pharmacology capabilities here, and read this issue of The Altascientist on Safety Pharmacology Guidelines and Practices to learn more about:
• the benefits of combining safety pharmacology studies (i.e., cardiovascular and
respiratory); and
• safety pharmacology endpoints in general toxicity studies.
QUESTIONS? SUBMIT AN INQUIRY.
You may also be interested in the following:
• Fact Sheet: Safety Pharmacology Studies
• Podcast: Altasciences’ Scientific Experts Discuss Safety Pharmacology
• ICH Guidance for Industry: S7A Safety Pharmacology Studies for Human Pharmaceuticals