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Drug Metabolites & Glucuronides

Metabolic profiles differ, depending on their clearance from the body via biotransformation. They may have a safety or unique profile in relation to the parent drug. The process of developing a drug includes detecting non-clinical safety assessment of a new chemical. It is done to establish the overall safety margins, toxic levels and the threshold of acceptance.  

SimSon Pharma follows key concepts related to testing drug metabolites and Glucuronides for global clients. Meeting regulatory perspectives of countries like USA, Brazil, Turkey, Russia, China and Jong Kong are important. Pharma industry based in these countries require the safety coverage related to metabolites in the right ratios. 

Safety Testing

The accurate knowledge related to metabolite profile allows the lab technicians to pay attention to the scientific drug development. Safety testing with appropriate guidance enables the metabolite reference standards to assess the evaluation and synthesis. Semi-qualitative methods are also required for safety assessment after human disposition. Metabolites may be present in vitro. It is processed after blood turns into plasma. Tests are conducted for its stability. At each stage, the samples need to be tested for outcomes. Depending on test results different solutions are provided to make the drug useful for patients.  

Methodology

We conduct bio analytical methods to check the drug concentration levels as per FDA regulations. It is popularly called Safety Testing of Drug Metabolites or MIST Guidance. It consists of a tiered approach to examination when the drug is still under development. The methods are used at every stage by our contract research team. We handle with care non quantifiable metabolites as well. 

We address method validation of major authorities like the FDA, Health Canada Therapeutic Products Directorate and Brazil ANVISA to cater to clients in these countries.  Our methods are also designed and documented to help pharma companies based in other nations. 

Methodological development involves:

  • Identifying the degree of presence of metabolites in the samples. 
  • Understand various challenges related to Aly-glucuronides and conversion to parent drug. They convert to parent drug in vivo, source/interface, or in vitro. They require additional methods of testing during injection and determine its extraction. 
  • Another reference standard is required for ketoprofen in human plasma. The optimization is required to chromatically separate the analyte and metabolite. Methods need to be changed to suit acceptable results that come in. 
  • Stability and chromatographic interference are investigated thoroughly at every phase. 

The Paracetamol Drug

Knowing about Glucuronide formation present in patients is significant- The M/P ratio i.e. metabolite to paracetamol.  Phenobarbital-type compounds increase the glucuronidation of structurally diverse compounds. The fate of the glucuronidated drugs in urine or bile depends on their molecular size.

We conduct the tests for several pharma-based clients to help them produce the best batches of branded and generic drugs to suit patients. 

SimSon pharma has a qualified team to understand the chemistry of compounds. We work regularly with client teams to determine the testing procedures and prepare the necessary documentation. Our experts use the right method for selective sample analysis as investigating agencies are equally selective before giving their assessments and drawing conclusions.