XTalks
JUNE 21, 2024
The ban targets artificial smoke flavorings linked to genotoxicity concerns. Genotoxicity involves damage to genetic material within cells, increasing cancer and inherited disease risks. The EFSA concluded that the majority of assessed smoke flavorings posed genotoxicity risks. Other companies, like I.T.S
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. .
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
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.
Pharmaceutical Technology
DECEMBER 9, 2022
Our laboratories operate to the highest quality standards under international organisation for standardisation (ISO), good manufacturing practice (GMP), good laboratory practice (GLP) and US Food and Drug Administration (FDA) regulations. Quality control release testing.
XTalks
MAY 13, 2022
Container closure systems are highly regulated by health agencies. USP and EP Organizations for Container Regulation. If they do, the FDA will assume the worst-case scenario and deem the compound or fragment to be genotoxic or eugenic. shaking, changes in pressure, etc.). Requirements for Primary Packaging Components.
The Pharma Data
MARCH 25, 2021
IBRANCE is an oral inhibitor of CDKs 4 and 6, 1 which are key regulators of the cell cycle that trigger cellular progression. IBRANCE may impair fertility in males and has the potential to cause genotoxicity. Pfizer will continue to share new data from these studies with the scientific community as results becomes available.
The Pharma Data
FEBRUARY 8, 2021
IBRANCE is an oral inhibitor of CDKs 4 and 6, 1 which are key regulators of the cell cycle that trigger cellular progression. IBRANCE may impair fertility in males and has the potential to cause genotoxicity. This extension does not include potential pediatric exclusivity. About IBRANCE® (palbociclib) 125 mg tablets and capsules.
Expert insights. Personalized for you.
52 
Let's personalize your content