Pharmaceutical Technology
FEBRUARY 23, 2023
EC’s approval comes after the Committee for Medicinal Products for Human Use’s positive opinion. The studies established bioequivalence between acalabrutinib 100mg tablets and acalabrutinib 100mg capsules. Findings demonstrated that the Calquence capsule and tablet formulations are bioequivalent in the trials.
Camargo
NOVEMBER 11, 2020
In November 2017, Foundation Medicine received approval for FoundationOne CDx , a genomic profiling test for solid state tumors, which paved the way for partnerships with pharma companies’ therapeutics. In 2019, Foundation Medicine and Bayer Healthcare Pharmaceuticals, Inc. for patients with NTRK fusion cancer across all solid tumors.
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Drug Patent Watch
DECEMBER 10, 2024
The Importance of Scientific Expertise Generic drug development involves a deep understanding of the scientific principles underlying drug development, including pharmacology, pharmacokinetics, and bioequivalence. Bioequivalence Studies : Bioequivalence studies are a critical component of generic drug development.
World of DTC Marketing
FEBRUARY 21, 2022
Pfizer and Merck have chosen to designate a select few generic manufacturers to produce cheaper versions of their drugs through the Medicines Patent Pool (MPP). Experts across the board are predicting demand for antiviral drugs will rapidly outpace supply. At this point, one must wonder why the U.S. About those copay cards.
Pharmaceutical Technology
JULY 25, 2022
As more competitors enter the market, the price of a treatment goes down, explains Stanford University professor of medicine Dr. Kevin Schulman. They are sometimes referred to as hybrid medicines by the European Medicines Agency (EMA). Drugs with an AB rating meet the required bioequivalence.
Drug Patent Watch
JANUARY 14, 2025
The Thyroid Association’s Concerns The American Thyroid Association (ATA) had raised concerns about the FDA’s methods for determining bioequivalence between levothyroxine products[2]. It’s being used extensively to reduce development costs and accelerate access to medicines[3].
Pharmaceutical Technology
OCTOBER 28, 2022
It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines. Biosimilars are biologic medical products that almost exactly replicate products already being manufactured by other companies.
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