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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.
In the US, the Food and Drug Administration (FDA) and the United States Pharmacopeia (USP) offer guidance for the development, application and use of appropriate container closure systems through the integration of analytical tests that ensure product integrity and compatibility. USP <1207.1>:
The FDA’s accelerated approval mechanism enables drugs that treat serious diseases with unmet medical need to be approved based on a surrogate or intermediate clinical endpoint. Premedicate with a two or three drug combination regimen (e.g., TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells.
Nat Rev Drug Discov. Exposure to sorbitol during lactation causes metabolic alterations and genotoxic effects in rat offspring. The obesity epidemic and food addiction: clinical similarities to drug dependence. J Psychoactive Drugs. Curr Drug Abuse Rev. Am J Clin Nutr. 1992;55(1):151S–154S. PMID: 1728825.
Food and Drug Administration (FDA) has granted full approval to Trodelvy ® (sacituzumab govitecan-hziy) for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. DRUG INTERACTIONS.
SG is a first-in-class therapy targeting Trop-2, a protein frequently expressed in multiple types of epithelial tumors, such as TNBC, where high expression is associated with poor survival and relapse. Premedicate with a 2- or 3-drug combination regimen (e.g., More information about ASCENT is available at [link].
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