Bioequivalency Containment Drugs Trials 
Pharmaceutical Technology
OCTOBER 28, 2022
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.
Camargo
NOVEMBER 11, 2020
When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely. Presumably, Antares’ long-established 90-person urology sales force can achieve pull-thru of this drug product.
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Camargo
DECEMBER 13, 2021
Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. Bispecific antibodies, antibody-drug conjugates, and gene therapies all have their own specific features that must be taken into account. Regulatory Considerations for Biologics.
The Pharma Data
AUGUST 5, 2020
The US Food and Drug Administration and European Medicines Agency are currently reviewing ofatumumab for the treatment of relapsing forms of multiple sclerosis (RMS) in adults . Disclaimer This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995.
The Pharma Data
FEBRUARY 1, 2021
Food and Drug Administration (FDA) has approved a new intramuscular (IM) injection route of administration for Plegridy ® ( peginterferon beta-1a ) for the treatment of relapsing forms of multiple sclerosis (MS). In clinical trials, the most common adverse events associated with Plegridy were injection site reactions and flu-like symptoms.
FDA Law Blog
JANUARY 23, 2023
Livornese — Last month, Congress took a big step towards improving clinical trial diversity by requiring sponsors of most drug and device clinical studies to submit a diversity action plan when they submit key trial documents to the Food and Drug Administration (FDA). This guidance was finalized in 2020.
Druggist
MARCH 25, 2021
Do generic, and branded drugs produce exactly the same effect? . Both contraceptives contain the same active ingredient: desogestrel (75 micrograms), a female sex hormone (synthetic progestogen). Both contraceptives contain the same active ingredient: desogestrel (75 micrograms), a female sex hormone (synthetic progestogen).
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