Bioequivalency Clinical Trials Containment 
Camargo
NOVEMBER 11, 2020
The speed of the submission in January 2020 and approval in October 2020 was attributed to the retrospective testing of available tumor tissue samples from patients enrolled in three clinical trials that led to the accelerated approval of larotrectinib.
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.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Camargo
DECEMBER 13, 2021
Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. PK studies are conducted to confirm that dosimetry remains unchanged, and toxicology studies are needed to confirm that the therapeutic ratio and safety profile remain unchanged.
The Pharma Data
DECEMBER 17, 2020
The trial remains on-track to complete enrollment of all 500 patients in the United States and Australia before the end of 2020, despite the worsening of the COVID-19 pandemic. In its Phase II clinical trial, TLC599 significantly reduced pain at and through every scheduled visit through six months.
The Pharma Data
AUGUST 5, 2020
Disclaimer This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Onset of B-cell depletion with subcutaneous administration of ofatumumab in relapsing multiple sclerosis: results from the APLIOS bioequivalence study. J Neurol Sci.
Druggist
MARCH 25, 2021
Both contraceptives contain the same active ingredient: desogestrel (75 micrograms), a female sex hormone (synthetic progestogen). A box of Cerelle or Cerazette pills comes with three blister blisters, each of which contains 28 mini-pills (note you may be prescribed just one blister = 28 pills). Both pills are taken in the same way.
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.
Expert insights. Personalized for you.
242 
Let's personalize your content