Search results for " efficacy"
Article
Novavax Reports on Two Vaccine Efficacy Studies
A large study of the NVX-CoV2373 vaccine enrolled nearly 30,000 participants in the United States and Mexico to evaluate efficacy, safety, and immunogenicity. The results showed an overall efficacy of…
Article
Optimizing Drug Safety and Efficacy of Complex Next-Generation Biologics
In recent years, the global biopharma industry has seen a rapidly advancing trend toward biotherapeutics or ‘biologic’ drugs—drugs that are produced from living organisms or contain components of li…
Article
Quality by design for biotechnology products—part 1
Safety, efficacy, convenience, compliance, and cost effectiveness of the product must be considered. Next, CQAs of the product are identified, based on the understanding of the impact of various quali…
Article
Reimagining Affordable Biosimilars
Other challenges for biosimilars are frequent failures in demonstration of biosimilarity and establishment of clinical equivalence for efficacy, immunogenicity, and safety (5). There is a growing need…
Article
Preclinical Evaluation of Product Related Impurities and Variants
Despite their success, the adoption of biotherapeutics is marred by issues around affordability as well as risks associated to the challenges in assessment of their safety and efficacy arising from th…
Article
Labeling of Biosimilars
Instead, a biosimilar has to demonstrate similarity to the reference product in terms of quality characteristics, biological activity, safety, and efficacy based on a comprehensive comparability exerc…
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
Biotech therapeutics, particularly complex products such as monoclonal antibodies (mAbs), can have numerous quality attributes that can potentially impact safety and/or efficacy of the product (2). Id…
Article
Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
QTPP is defined in ICH Q8 (R2) as "a prospective summary of the quality characteristics of a drug product that ideally will be achieved to ensure the desired quality, taking into account safety and ef…
Article
An Analytical Approach to Biosimilar Drug Development
By Feliza Mirasol
The long-term safety and efficacy of biosimilars are largely based on clinical studies that have already been conducted on the reference biologic, but these studies may…
Article
Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
…ssible to predict that any differences in quality attributes have no adverse impact on the safety or efficacy of the drug product (16). Manufacturing changes may be frequent and approval times for ch…