Search results for " efficacy" in Articles / App Notes
Article
Drug Quality Key to Innovation and Access
Some regulatory officials and consumer advocates fear that pressure to provide early access to medicines, despite safety signals and limited evidence of efficacy, will undermine the FDA approval proce…
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Biosimilars to Drive Modern Manufacturing Approaches
With 20 or 30 manufacturing changes common over a product’s lifetime, biosimilar developers want to avoid repeated safety and efficacy studies with every alteration. Instead, they want to rely on comp…
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Establishing Acceptance Criteria for Analytical Methods
Generally, to control the quality of a product and to manage drug safety and efficacy, there are two key elements: cinical trials evaluting the pharmacokinetics (PK) response to drug product and dose …
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Perfusion in the 21st Century
Notably, because of the sophistication and efficacy of the controls used for all aspects of perfusion processes, such as pumps with feedback control or advanced in-line and on-line analytical tools, i…
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Vaccine Development Faces Urgency and Challenges
Meanwhile, testing continues on Ebola vaccine candidates that have produced evidence of safety and efficacy from “emergency use” and initial clinical studies. Merck announced advanced clinical trials …
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Lessons Learned Accelerate Vaccine Development
He also notes that efforts are underway to streamline the timing of proof-of-concept clinical studies for new vaccines so that they can be more rapidly evaluated for efficacy prior to large-scale deve…
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Antibody Production in Microbial Hosts
Recent success in aglycosylated IgG production and clinical efficacy data indicates that they may have even more applications in the future.
Conclusion
The development…
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Going Small to Achieve Success on the Commercial Scale
Unlike initial processes that are used during the discovery and early development phases to produce material for characterization, efficacy, safety, and other studies, scale-down models are intended t…
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Implications of Cell Culture Conditions on Protein Glycosylation
These structural variations can have a large effect on the drug’s efficacy and properties.
By chemically modifying the permethylated glycans and attaching particular “reporter groups” wherever each…
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Biopharma Advances Demand Specialized Expertise
Those companies that are best able to successfully characterize and differentiate innovator and biosimilar products for safety and efficacy will have the greatest opportunity to benefit.
The knowle…