Search results for " safety"
Article
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…
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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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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…
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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…
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Brazil Emerges as Global Biopharm Collaborator
Brazil is also controlling the efficacy and safety of pharmaceutical products through market regulation.
According to Guimarães, considering government expenditures with health products, biophar…
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Predicting Progress in Protein Aggregation
If aggregation occurs during formulation, which is of particular concern for protein-based products that require high concentration, the performance and safety of the product can be affected. “There i…
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Best Practices in Adopting Single-Use Systems
Vendors have taken on the burden of documenting their products’ suitability and safety, which had previously fallen to a large extent on end-users. Moreover, the 5- to 10-fold improvement in product t…