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 […].
Camargo
DECEMBER 22, 2021
For example, streamlined programs can be limited to literature searches, nonclinical studies, demonstration of bioequivalence to an approved product, or a combination of nonclinical and bioequivalence studies, and their relatively low costs may be appealing. Pediatric Research Equity Act (PREA) Requirements.
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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. . ” .
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. Also, sometimes traditional bioequivalence approaches will not be possible and investment in expensive clinical trials are warranted.
Camargo
DECEMBER 13, 2021
Both the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products, which are subject to both the Federal Food, Drug and Cosmetic (FD & C) Act and the Public Health Service (PHS) Act.
The Pharma Data
FEBRUARY 1, 2021
The FDA’s approval of the IM administration for Plegridy is based on data evaluating bioequivalence and adverse reactions associated with IM administration compared to SC administration in healthy volunteers. percent vs. 32.1 Available at: [link] Accessed: January 2021. 3 Zhao Y, et al. Source: Biogen.
The Pharma Data
SEPTEMBER 26, 2021
Head of Research and Development at Biogen. “We anticipate to advancing Biogen’s portfolio and continuing to figure with the MS community to deal with critical treatment challenges, including people who affect persistence and adherence to medication for this chronic and life-long disease,” said Alfred Sandrock, Jr.,
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