In the quality consistency evaluation of generic drugs, Medicilon has successfully completed many quality consistency evaluations. With rich experience in generic drug R&D, we can provide you with more professional consistency evaluation services.
The quality consistency evaluation of generic drugs focuses primarily on the re-evaluation of the quality of the oral solid preparations (including tablets, capsules, and granules) approved before the promulgation and implementation of the Drug Registration Administrative Measures in 2007. The evaluation mainly investigates the consistency of pharmaceutical quality and efficacy.
Pharmaceutical quality evaluations primarily investigate whether the key quality indexes of domestic generic drugs – such as dissolution and related substances – are consistent of those of reference preparations.If the quality is inconsistent, the drug manufacturer needs to re-develop the product formulation process.
Our Generic Drug Quality Consistency Evaluation Service Platform is available for the:
Comprehensive comparison of the quality of reference preparations and generic drugs
Discovery of determination conditions for the four dissolution curves, the dissolution curves of reference preparations and generic drugs, and the comparison of those dissolution curves;Determination of methods for related substances and isomers, and as well as the determination of related substances, contents, and isomers in reference preparations and generic drugs;Research on crystal forms of API used in reference preparations and generic drugs;Stability study (including influencing factors, accelerating influences, and long-term influences).
Formulation process re-development
Further research on the quality of the original preparation;Full research on API properties;Optimization of the formulation process to ensure the durability of said process through step-by-step pilot-scale testing;Pilot-scale testing /production technology transfer;Quality research
BE tests with animals
We have animal laboratories and testing centers in compliance with GLP certification. As such, we are able to conduct BE testing with animal subjects such as beagles or crab-eating macaques, providing data support for preparation optimization and reducing clinical BE risks.
Report templates and SOPs
Completion of analysis based on clients requirements;Accurate and compliant documents;High-quality raw data that is traceable, of high integrity and NMPA compliant.
Advantages of our Generic Drug Quality Consistency Evaluation Center
Professional operations and team, with multiple generic drugs successfully filed with the FDA and NMPA;Complete quality assurance system to ensure the accuracy, authenticity, traceability and integrity of data;Efficient workflow, standardized operations, and complete schemes and report templates;Advanced instruments, including optical-fiber online automatic dissolution detector and GMP-compliant solid preparation pilot-scale test workshop, so to ensure the project efficiency and completion;Good clinical research partners.
Our Generic Drug Quality Consistency Evaluation Service Platform is available for the:
Relevant laboratories
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