Remove Bioequivalency Remove Development Remove In-Vivo Remove Marketing
article thumbnail

In the News: October Regulatory and Development Updates

Camargo

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. The “skinny label” has been used many times previously to enable ANDA applicants to reach the market in similar circumstances. In October, the U.S.

article thumbnail

The Composition and Value of a Portfolio Analysis

Camargo

Informed by today’s competitive drug development landscape, as well as by the sponsor’s strategic goals and capabilities, a portfolio analysis involves assessing product concept and differentiation, strategic planning, factoring in unmet patient needs, and estimating timelines and expenses. Fine-Tuning Strategic Assessment.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Pioneering access to complex generic products 

Drug Discovery World

Originator pharma companies are developing ever more complex products, which are transforming the medical landscape, but their cost places an increasing burden on healthcare budgets worldwide. It could also include specialty products that are harder to develop compared to standard generic products. What are complex generics?

article thumbnail

The Important Role that Biopharmaceutics Plays in Accelerating Early-Phase Drug Development

Pharmaceutical Technology

Quotient Sciences helps biotech and pharma customers in the development and optimization of drug products. Our chemists and formulation scientists review the properties of new drug candidates and “work their magic” to develop formulations that improve the exposure profile of the compound.