Consistency Evaluation
Generic drug consistency evaluation refers to the quality consistency evaluation of the approved generic drugs in stages and batches according to the principle of consistency with the reference preparation in terms of quality and efficacy. The evaluation mainly examines the consistency of pharmaceutical quality and efficacy. The pharmaceutical quality evaluation mainly examines whether the generic preparation and the reference preparation are consistent in the dissolution curve and key quality indicators such as crystal form, particle size and impurities. The efficacy evaluation mainly examines bioequivalence and clinical effectiveness.
Our Quality Consistency Evaluation Services Mainly Include:
Consistent Evaluation of Pharmaceutical Quality:
Literature research, determination of reference preparations.
Pre-formulation studies identify key attributes of the drug substance.
Determine the evaluation method of key indicators (including the evaluation method of dissolution)
Comprehensive comparison of the quality of reference preparation and generic drugs.
Determine the conditions for the determination of the dissolution profiles of the reference preparation and the generic preparation, and compare the dissolution profiles;
Determine the measurement methods of related substances, contents,
etc
., and measure the related substances, contents, isomers,
etc
. of reference preparations and imitation preparations;
Research on the particle size and crystal form of the raw materials used in the reference preparation and the generic preparation;
Stability studies.
Formulation process optimization and improvement.
Research on preparation quality and improve quality standards.
A pilot scale-up study of the formulation.
Production technology transfer.
Consistent Evaluation of Efficacy:
Design of the research protocol.
Generic drug bioequivalence (BE) pre-test and formal test to meet customer needs.
Standardized clinical research.
In vivo
drug concentration detection method development and analytical detection.
Electronic management of clinical data.
Pharmacokinetic analysis statistics.
