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Quality by design with a focus on biosimilars

Pharmaceutical Technology

To demonstrate bioequivalence for a generic small molecule drug, a company must carry out a Phase I clinical trial in healthy individuals to ensure that the area under the curve and maximum plasma concentration for their drug is equivalent to that of the brand name drug.

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Hitting Pause on Criticism of the FDA, Just for Today

Pharmacy Checkers

The FDA’s capacity to evaluate new and generic drug applications and its oversight over drug manufacturing are why we have this degree of assurance. For new or generic drugs to work in a patient, they must, of course, be made correctly by using Current Good Manufacturing Practices. and other high-income countries.

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Through the Looking Glass: Is FDA really the “Gold Standard” in Drug Safety?

Pharmacy Checkers

The GAO’s preliminary analysis on inspections brings back into light what Katherine Eban so passionately – and dramatically – exposed in her book Bottle of Lies: The Inside Story of the Generic Drug Boom.” When it comes to the approval of new drugs, brand and generic, the systems of the U.S.

Drugs 71
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Trump’s Pakistani Imported Chloroquine Phosphate: FDA Inspections vs. EU Testing to Ensure Drug Safety

Pharmacy Checkers

Yet, independent testing of about a thousand prescription drug orders has shown that personal drug importation can and is done very safely. The results? Many manufacturers have not always acted honorably, so the system doesn’t work too well.

Drugs 53
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PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

The Pharma Data

On December 21, 2020, which falls in Pfizer’s international first-quarter 2021, Pfizer and Viatris completed the termination of a pre-existing strategic collaboration between Pfizer and Mylan for generic drugs in Japan (Mylan-Japan collaboration) and Pfizer transferred related operations that were part of the Mylan-Japan collaboration to Viatris.

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COVID-19 Pandemic Coverage

XTalks

For example, Tailored Brands, the parent of Men’s Wearhouse and K & G, have declared they may have to file for bankruptcy protection, joining almost 7,000 other companies that filed for Chapter 11 bankruptcy protection last year. Meanwhile, the Congressional Budget office predicted that the US economy would expand at an annual rate of 12.4