Preclinical Research
Case Study―Safety Assessment of Intravitreal Implants in Dutch Belted Rabbits
ISSUE NO. 27 — The Complexities of Early-Phase Ophthalmic Drug Development
Ophthalmic medications have a particular set of challenges that can impact their speedy and successful path to market. From prototype formulation through preclinical testing, early-phase clinical and manufacturing and development, ophthalmic drug development presents with specific and unique complexities. It is best to entrust drug development to a partner with regulatory knowledge, technical expertise, and a thorough understanding of the market in this growing therapeutic area. From current reality to future trends, being at the forefront of ophthalmic drug development delivers tangible benefits to sponsors.
In Issue 27 of The Altascientist, we dive into all areas of ophthalmic drug development, including:
- Prototype development, formulation, and manufacturing
- Preparing for first-in-human studies
- Species and strain selection parameters
- Routes of administration
- Specialized ocular assessments and equipment
- bioanalysis
- Phase I clinical research
- Phase II to commercialization
Three case studies are also included!
Comparing Cytokine Data to In-Life Parameters on Nonhuman Primates in Nonclinical Toxicology Studies
The Impact of Social Factors on Drug Development
Drug development exists within the context of interrelated social factors that impact its norms and practices.
One Integrated Solution for Meeting Your Preclinical to Clinical Drug Development Needs
Establishment of Historical Control Reference Values of Cambodian Cynomolgus Macaque Blood Gases
Evaluating Cytokine Data in Nonhuman Primate Safety Assessment Studies: A Correlation to Toxicity Outcomes
Up Close and Personal with Dr. Simone Iwabe, DVM, PhD, DACVO
Meet Dr. Simone Iwabe, DVM, PhD, DACVO
Senior Veterinary Ophthalmologist
Test Your Preclinical Toxicology Knowledge
In drug development, toxicology evaluates and examines adverse effects of an investigational product on a living organism to determine its initial safety and dose-specific effects. But did you know that toxicology is not limited to drug development? Toxicology is a branch of science that deals with toxins and poisons, and their effects and treatment; other types of toxicology include forensic toxicology, environmental toxicology, food toxicology, and veterinary toxicology.
Take this quiz to discover how much you know (or don’t know) about toxicology.
Five Things You Need to Know About Partnering with an Integrated CRO/CDMO
We are often asked about the advantages of working with an integrated CRO/CDMO.