XTalks
MAY 13, 2022
A container closure system consists of all the packaging components that contain and protect a pharmaceutical product. Container Closure Systems. A container closure system protects the product from environmental conditions, safeguarding a product’s purity, strength, safety and efficacy.
Roots Analysis
MARCH 1, 2023
Genotoxicity testing refers to the evaluation of detrimental effects of chemical or physical agents on the genetic processes and related hereditary material of living cells. Mechanism of Genotoxicity / Mutagenicity The interaction of genotoxins / mutagens with the structure of DNA causes damage to the genetic material.
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Pharmaceutical Technology
DECEMBER 9, 2022
Our QC testing capabilities range from solids, semi-solids and liquids for oral, inhaled and injectable use to packaging materials, including rubber closures, glass and plastic containers. In particular, we can correctly identify and quantify all five nitrosamines found in recent recalls of angiotensin II receptor antagonists (sartans).
The Pharma Data
FEBRUARY 8, 2021
IBRANCE may impair fertility in males and has the potential to cause genotoxicity. DISCLOSURE NOTICE : The information contained in this release is as of February 5, 2021. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
The Pharma Data
MARCH 25, 2021
SG contains a genotoxic component and can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. In addition to the European Union, regulatory reviews of SG in metastatic TNBC are currently underway in the U.K., Embryo-Fetal Toxicity.
Camargo
APRIL 20, 2021
Sponsors can select the patient population and leverage companion diagnostics, and nonclinical study requirements such as genotoxicity and carcinogenicity studies can often be waived or delayed to later stages of development, especially for end-stage cancer therapies. A strong IP position.
The Pharma Data
APRIL 14, 2021
Accelerated Approval Granted for Locally Advanced or Metastatic Urothelial Cancer Following a Platinum-Containing Chemotherapy and a PD-1/PD-L1 Inhibitor –. – New Indication Marks Second FDA Approval for Trodelvy in 2021 –. TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells. FOSTER CITY, Calif.–(BUSINESS
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