Veterinary Drug Bioequivalence Test

Bioequivalence (BE) study is an important part of the registration of veterinary chemical declaration. The design of the protocol, the planning of the statistical analysis, the running of the trial process, and the formation of the statistical and summary reports all require a very professional team.

Our company has been engaged in clinical trials for many years and has rich resources to provide customers with complete BE study CRO services, and provide technical guidance to customers throughout the process, monitor the BE study process and project management in accordance with international standards to assist customers to complete BE tests as soon as possible, so as to complete the declaration as soon as possible and seize the market opportunity.

Why Choose Our Veterinary BE Study Service?

BE studies have different roles in different stages of veterinary drug development.

• In the new veterinary drug research stage, in order to determine the rationality of the new veterinary drug prescription and process, it is usually necessary to compare whether the formulation can achieve the expected bioavailability after changing the above factors.
• To develop a new dosage form, BE studies can be conducted to confirm whether the new dosage form is equivalent to the original dosage form.
• In clinical trials, BE studies can be used to verify the before-and-after consistency of products from different periods of the same drug.
• In the process of generic development, BE study can prove whether the generic formulation is bioequivalent to the original formulation and whether it can be used in place of the original formulation.
• After a veterinary drug is approved for marketing, if there is a certain degree of change in the composition, ratio and process of the prescription, the investigator needs to determine whether to conduct a BE study according to the degree of change in the product to examine whether the product is bioequivalent after the change and before the change.

The clinical significance of BE studies is to determine the prescriptibility of veterinary drugs and the interchangeability between veterinary drugs.

Our company's One-stop Shop

Our company offers a one-stop-shop for the entire BE research process:

1. Detailed research of the project and contacting collaborators.
2. Drafting of protocols, statistical analysis plans, etc.
3. Project initiation, monitoring, and management.
4. Formation of statistical analysis and summary report and handover.
5. On-site verification by drug regulatory authorities.
6. Assist customers in registration tracking of projects.

BE Test Service Information

BE study methodology

We mainly conduct BE studies of veterinary drugs through pharmacokinetic studies. Other methods (special cases) include pharmacokinetic studies, clinical studies, and in vitro controls.

BE statistical methods

Mean bioequivalence (Interchangeability), population bioequivalence (Prescribability), and individual bioequivalence (Switchability).

Experimental design of BE

Standard 2×2 crossover design, parallel design, replicate design, and others.

The Our company Advantage

• Comprehensive, one-stop BE (including pre-BE and formal BE) solutions.
• A professional clinical testing center to ensure the speed of trials.
• First-class technical standards set by a team of experts to ensure the quality of trials.
• A large number of successful cases of pre-BE and formal BE, with rich trial experience.
• Precisely grasp the characteristics and difficulties of the project and develop a scientific and reasonable study plan.

For more information, please feel free to contact us.

It should be noted that our service is only used for research, not for clinical use.