article thumbnail

The Composition and Value of a Portfolio Analysis

Camargo

In addition, the size and complexity of a development program can vary significantly depending on product characteristics, market dynamics, and regulatory pathway. Clinical pharmacology may also involve comparative bioavailability analyses, which are generally required for drug formulation bridging studies, to demonstrate bioequivalence.

article thumbnail

Present Treatments & Hopeful Future Directions for ALS Pharmacotherapies

Worldwide Clinical Trials

Since marketing authorization for the first breakthrough treatment in 1994, the steady increase in clinical trials reflects the community’s commitment to finding effective ALS treatments despite the numerous hurdles associated with clinical trial design, from proof-of-concept to pivotal trials. Director, Therapeutic Area Medical Lead.

Gene 204
Insiders

Sign Up for our Newsletter

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

article thumbnail

Topical products: Aiming for quality, simplicity, and cost-efficiency in their development, scale-up, and manufacturing

Pharmaceutical Technology

It requires having access to proper techniques and skill sets, state-of-the-art equipment, process scientists and engineers who have a deep understanding of Quality by Design (QbD) principles, and methods for product and process characterisation. In vitro release testing to demonstrate bioequivalence. Simplicity matters.

article thumbnail

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

Pharmaceutical Technology

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. Quotient Sciences helps biotech and pharma customers in the development and optimization of drug products. Please check your email to download the Whitepaper.