Preclinical Research
Hybridization LC-MS/MS for Sensitive Quantitation of Antisense Oligonucleotides in Plasma and Dried Blood Microsamples
Best Practices for Preclinical Dose Range Finding Studies
Dose range finding (DRF) studies are the foundation of preclinical drug development, providing crucial information on safety data to assist in the dose level selection before advancing into to
Inside Preclinical Ocular Research: With Dr. Simone Iwabe, DVM, PhD, DACVO, and Randy Wheeland, BS
Altasciences has been at the forefront of ophthalmic drug development for over 30 years, having completed more than 100 ocular studies to assess the safety of new drug products intended for human use.
ISSUE NO. 43 — Advancing Vision Care With Formulation and Manufacture of Ocular Therapeutics
According to the WHO, at least a billion people are currently living with vision impairment from a preventable or treatable source. Precedence Research reports that the global ophthalmic drug market size is estimated to double in 10 years, from $34.6 billion in 2021 to an estimated $68.93 billion by 2030.
The development of pharmacological interventions for many of these conditions has been accelerating, supported by new delivery methods and formulation approaches. For conditions that require surgery or corrective devices, eye drops are an important part of diagnosis, and pre- and post-surgery treatment plans.
In Issue 43 of The Altascientist, we explore key considerations for ophthalmic product manufacturing, including formulation, scalability, regulatory compliance, and quality control:
- Recent developments in ophthalmic medications
- Unique barriers for drug delivery to the eye
- Common types of ocular formulations
- Formulation for effective ocular drug delivery
- Systemic exposure of topical ophthalmic preparations
- Ocular gene therapy
- Manufacturing ocular drugs for clinical trials and commercialization
- A case study
THE CHALLENGES OF OCULAR DRUG DELIVERY
The eye has natural anatomical barriers that restrict the amount of medication reaching its intended target. These include the cornea’s outer layer, the conjunctiva, and the blood-aqueous and blood-retinal barriers. These structures resist water-based drugs, limit absorption, and tightly regulate what enters the inner eye. Additionally, the eye's rapid tear film turnover continuously flushes out medication.
Subretinal Injection of Sodium Iodate Creates a Geographic Atrophy-Like Model in Nanopigs™
Evaluation of Formulation pH Tolerability in New Zealand White and Dutch Belted Rabbits Post-Intravitreal Administration
A 13-Week Dermal Toxicity Study of VIM-004 Gel, a STAR Particles Based Formulation in Göttingen Minipigs®
Targeted Gene Therapy for CNS Disorders: Precision of Intra-Cerebroventricular (ICV) Delivery and Post-Administration Behavioral Assessments in Mice
Bestrophin-Like Lesions Described in Dutch Belted Rabbits
Standardization and Harmonization of Altasciences Historical Control Database Development Using Certara SEND Explorer® for Integrated Toxicological Evaluation