Search results for " safety" in Articles / App Notes
Article
Vaccine Development and Production Challenges Manufacturers
The planned three-arm randomized, double-blinded trial began in early February 2015, and aims to enroll 27,000 healthy volunteers to support this effort to collect clear evidence of safety, efficacy, …
Article
Tackling Analytical Method Development for ADCs
Testing for safety and quality attributes (bioburden, endotoxin, pH, osmolality, excipients, and appearance) are either verified using compendial-based platform methods or developed per product.
A…
Article
FDA Approves First Biosimilar
…a, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data, and other clinical safety and effectiveness data—all of which support Zarxio’s use in clinical practice, said Dr. Lou…
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Technologies and Practices Must Evolve to Meet Demand
More than 10% of the respondents, however, rated sterile sampling and virus safety solutions as “poor” (Table II).
Respondents further identified problem areas. More than 30% of the respondents li…
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New Era for Generic Drugs
Recent Supreme Court decisions have raised questions about the adequacy of safety information in generic-drug labels, prompting FDA to propose a new rule on labeling changes that generics manufacturer…
Article
Setting Standards for Biotech Therapeutics in India
Many new general chapters pertaining to topics such as therapeutic monoclonal antibodies, host cell proteins and DNA, and viral safety are in the works for the next IP edition.
As mentioned previo…
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A Q&A With Dr. Anurag Rathore About the Future of QbD, Part I
Third is increased focus on relating the quality attributes of a biotech product to its clinical safety and efficacy. Fourth is the extension of the QbD concepts from the traditional process developme…
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EMA Invites Comments on New Guidance for Vaccine Development
The guidance on enhanced safety surveillance for seasonal influenza vaccines, which was adopted as a stand-alone document in April 2014, will be annexed to this module following its finalization.
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Article
Design of Experiments for Analytical Method Development and Validation
Design of experiment is a powerful development tool for method characterization and method validation.
Design of experiments (DOE) is a well-proven characterization approach within product…
Article
The Affordable Care Act's Impact on Innovation in Biopharma
With an increasing emphasis on post-market safety surveillance and real-world evidence, companies must have the appropriate measures put in place to capture this information.
• Clinical groups wil…