Consistency Evaluation

The field of generic drug development covers various dosage forms such as tablets, capsules, granules, injections, syrups, and oral liquid preparations. BOC Sciences has accumulated rich experience in the development of generic drugs, and can currently provide all services in the pharmaceutical part of consistency evaluation, including drug formulation and process optimization, pilot scale-up, dissolution curve fitting of generic and reference preparations, methodological research, in-depth comparison of impurity profiles, stability research, and formulation of quality standards, and assist in the formulation of scientifically reasonable bioequivalence test protocols. Our research goals are high quality, controllable cost, and production feasibility, and ensure that the entire process complies with regulatory requirements.

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.
1. Determine the conditions for the determination of the dissolution profiles of the reference preparation and the generic preparation, and compare the dissolution profiles;
2. Determine the measurement methods of related substances, contents, etc., and measure the related substances, contents, isomers, etc. of reference preparations and imitation preparations;
3. Research on the particle size and crystal form of the raw materials used in the reference preparation and the generic preparation;
4. 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.

Fig. 1 Consistency evaluation service process

Our Service Advantages:

Advantage 1: Professional work background

Our R&D team has successfully completed a number of quality consistency evaluation cases and has extensive experience in generic drug development.

Advantage 2: Excellent R&D team

Our R&D team has solid theoretical knowledge and rich practical experience, is familiar with relevant regulations, and is proficient in the R&D process.

Advantage 3: Perfect quality control system

Our research and development work has corresponding management regulations, and the instruments and equipment have standardized operating standards. Our complete quality control system ensures the accuracy, authenticity, traceability and integrity of data.

Advantage 4: Advanced instruments and equipment

We have a GMP-compliant preparation workshop, equipped with high-performance liquid chromatography, gas chromatography, atomic absorption analyzer, dissolution apparatus, infrared spectrometer, rotary tablet press, high-efficiency coating machine and other equipment to ensure the efficiency of project completion and time.

Advantage 5: Complete scheme and report templates

We complete the corresponding analysis terms in accordance with the requirements of our customers, we provide accurate and compliant documents and high-quality raw data that meet regulatory requirements.

Advantage 6: Good partners

We have established cooperative relationships with reliable clinical research institutions, and have good communication channels with review departments to meet the needs of customers for one-stop services.

BOC Sciences can provide pharmaceutical companies with a number of professional technical support and services for drug consistency evaluation with the help of the company's sufficient talent and technical team and sufficient instruments and equipment.