ProRelix Research
JUNE 29, 2022
The post Oncology Bioequivalence Clinical Studies appeared first on ProRelix Research. According to the World Health Organization (WHO), cancer is the leading cause of death worldwide, accounting for nearly 10 million deaths in 2020 (1). In addition, GLOBACAN estimated 19.3 […].
Worldwide Clinical Trials
MAY 30, 2024
Authors: Rich Worldwide Clinical Trials Exec. These advancements have fostered increased focus from politicians, policymakers, and the investment communities backing academic and industry-sponsored research projects. Director, Therapeutic Strategy Lead, Neuroscience & Lucie Undus, MD PhD, Exec.
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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.
Drug Discovery World
AUGUST 22, 2023
In many cases, it is also challenging to apply traditional bioequivalence methods or to ensure clarity about the comparison model (in-vitro/in-vivo) needed to gain health authority approval. In all, around 130 clinical trials are ongoing for oligonucleotides.
Camargo
JULY 8, 2021
Researchers at the Broad Center of Regenerative Medicine and Stem Cell Research at UCLA have observed that MAOIs might help the immune system attack cancer. The FDA itself did not produce the assessment but instead contracted the Eastern Research Group to conduct the assessment and produce a report. . ” .
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.
Druggist
MARCH 25, 2021
For example, testing in animals or humans (clinical trials) is limited for a generic medication to be authorised. Generic medicines must go through bioequivalence studies to show that generic medicine produces the same amount of active drug in the body. Bioequivalent studies may involve humans or animals (EMA, 2012). .
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