Bioavailability Studies
Bioavailability (BA) studies are an important basis for selecting appropriate routes of administration and determining drug regimens in rare disease research. Our company has the capabilities and resources to provide bioavailability and bioequivalence study services to ensure that we can quickly respond to the changing needs of your research projects.
Introduction to Bioavailability
Bioavailability (BA) refers to the extent and rate at which an active pharmaceutical ingredient or the active portion of a drug is absorbed and utilized at the site of drug action. If two medicines have similar bioavailability, they are called bioequivalent. Bioavailability studies are important elements to support lead optimization and IND-enabling and play a key role in the development process of rare disease drugs.
Applications of Bioavailability Studies
In vivo bioavailability studies are conducted to determine the basic pharmacokinetic parameters of a new drug after single and multiple doses, including absorption rate, the extent of absorption, excretion and metabolism rates, and elimination half-life. Bioavailability studies are conducted by measuring the concentration of the drug in plasma or blood after administration, and the data obtained from the bioavailability studies are used in subsequent bioequivalence studies.
Fig.1 Schematic representation of Bioavailability. (Sharma, S., et al., 2017) Our Services
With a highly professional pharmacokinetic team and extensive experience in bioavailability studies, our company provides complete bioavailability study services including absolute bioavailability studies, relative bioavailability studies, and bioavailability studies, and provides high-quality one-stop service processes.
- Biological Sample Analysis
Providing efficient methods to evaluate several characteristics in plasma, whole blood, or urine for bioavailability. - Experimental Design and Execution
Providing a complete and standardized in vivo pharmacokinetic analysis platform for bioavailability studies. We can customize experimental designs for the project according to the specific requirements of our clients.
Animal models
Our company can provide a variety of animals of different species for in vivo studies, covering a variety of experimental animals required for preclinical rare disease drug development.
Dosage forms
Our company can study a full range of BA/BE dosage forms, including immediate release (IR), controlled release (CR), extended release (ER), solid oral, orally dispersible tablets (ODT), etc.
Bioanalysis
Our company has a complete bioanalytical laboratory that can provide LC-MS/MS, HPLC, immunological and microbiological technologies for bioanalysis.
- Data Analysis
Our company has a professional team that can provide you with superior data quality including AUC, Cmax, Tmax, and other parameters for bioavailability studies data analysis.
Why Choose Us?
- Professional technical support
- The rich experience accumulated in successful cases of new drug development
- Careful design and transparent operation process
- Ph.D.-level scientists and skilled technicians
- High-quality one-stop service
Our company has a long-term commitment to the development and application of bioavailability. We can provide comprehensive services to leading and emerging biopharmaceutical companies and scientific research institutions to improve bioavailability studies for rare diseases. If you are interested in our services, please feel free to contact us for more information.
Reference
- Sharma, S., et al., "Radiopharmaceuticals regulations on bioavailability and bioequivalence: present status and future requirements." Mod. Appl. Bioequiv. Bioavail 1 (2017): 1-4.
All of our services and products are intended for preclinical research use only and cannot be used to diagnose, treat or manage patients.