The Pharma Data
MAY 3, 2021
The International Council for Harmonization (ICH) recently announced that its guideline establishing new permitted daily exposures (PDEs) for three residual solvents had reached Step 4, meaning the guideline can now be implemented by regulators. . RELATED: FDA consults on ICH residual solvent guideline , Regulatory Focus, 26 May 2020.). .
Drug Discovery World
JANUARY 10, 2024
These therapies, which exhibit substantial long-term side effects, including genotoxicity and an increased predisposition to secondary cancers, have significantly higher rates of subsequent malignancies than the rate reported for patients following CAR-T cell immunotherapies. .”
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Pharmaceutical Technology
DECEMBER 9, 2022
Our comprehensive analytical testing portfolio integrates a broad range of capabilities spanning all stages of drug discovery, development and manufacturing. Solvias is well equipped to provide stability testing for all stages of drug development. Integrated analytical services for pharmaceuticals. Quality control release testing.
XTalks
MAY 13, 2022
Container closure systems are highly regulated by health agencies. With a network including North America, Europe and Asia, Curia aims to improve patient outcomes and quality of life by offering a complete suite of solutions across its three divisions: Discovery, Development and Analytical (DDA), Drug Product and API Manufacturing.
Pharmaceutical Technology
SEPTEMBER 10, 2008
NC: What are the most recent developments in your genotoxicity studies and which are proving most successful? IS: Our genotoxicity testing includes the core battery of the tests requested by EMEA/ICH including mutagenicity in vitro, chromosomal aberration test in vitro and micronucleus test in vivo.
The Pharma Data
FEBRUARY 8, 2021
The PTE certificate was granted under the patent restoration provisions of the Drug Price Competition and Patent Term Restoration Act of 1984. This PTE will be listed in Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), published by the U.S. Food and Drug Administration (FDA).
The Pharma Data
MARCH 25, 2021
Food and Drug Administration more than six years ago, IBRANCE has been prescribed to more than 380,000 patients across more than 100 countries. IBRANCE is an oral inhibitor of CDKs 4 and 6, 1 which are key regulators of the cell cycle that trigger cellular progression. About the IBRANCE Real-World Evidence Program. 2,3 In the U.S.,
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