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Altasciences' Proactive Drug Development Solution: Small Molecules
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!
One Integrated Solution for Meeting Your Preclinical to Clinical Drug Development Needs
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.
Five Ways Altasciences Simplifies the Drug Development Process for You
Bringing new drugs to market, from lead candidate selection through preclinical testing, to clinical proof of concept, is a complex, time-consuming, and costly process.
Making Early-Phase Drug Development Faster, Better, and More Efficient
Early-phase drug discovery and drug development are complex processes, where many moving parts can, and do, influence the success of a program.
ISSUE NO. 6 — Hybrid Medicines and 505(b)(2) NDA Approval Pathways
Hybrid medicines are drugs based on a generic molecule, and have a different route of administration, format, strength, or indication from the original reference product. They require re-approval for market authorization, partly based on data from the original reference medicine, and partly on data from new clinical trials on the modified version.
Like the hybrid medicine authorization process in the European Union, the 505(b)(2) new drug application (NDA) approval process in the United States applies to generic molecules that have a slight change from the reference medicine, and can use published data, including previous FDA submissions and communications, to support their re-approval by the FDA.
In Issue 6 of The Altascientist, we explore the 505(b)(2) NDA approval pathways and their benefits over generic approvals, relevant drug categories, and key strategies for market authorization:
- Applicable categories of drugs for hybrid or 505(b)(2) pathways
- Hybrid or 505(b)(2) vs. generics
- Choosing a drug candidate
- A case study: Achieving a 505(b)(2) Regulatory Approval