Search results for "metric"
Article
Trends in BioPharma Approvals in 2013
Twenty approvals, by any metric, is a healthy headline number. Digging a little deeper, however, reveals that just over two-thirds of these (a still credible 14 products) were genuinely new first time…
Article
Trends in Downstream Bioprocessing
As titers have increased, new technology and the realization that most drugs will not require metric tons of product have reduced the perception of a downstream bottleneck.
So what activities have…
Article
Regulatory Challenges in the QbD Paradigm
Metrics are developed to understand the impact of regulatory decisions. Under the QbD paradigm, the success or failure of a marketed pharmaceutical product is assessed to incorporate lessons learned i…
Article
The Lifecycle Change of Process Validation and Analytical Testing
In the two years since the publication of FDA's final process validation guidance, how has this new lifecycle approach affected the way the industry performs validation? BioPharm Internati…
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…sfaction or other needs and interests;
To perform information analysis, compliance audits, and data metrics;
To evaluate the use and the effectiveness of the Services that we offer which can include …