Bioavailability and Bioequivalence Assessment for Nucleic Acid Drugs

CD Formulation is a full-service nucleic acid drug discovery company that develops a wide range of drug formulations, provides best-in-class bioequivalence services, and fully and efficiently supports our clients with bioequivalence and bioavailability studies.

About Bioavailability and Bioequivalence Assessment

Bioavailability refers to the percentage of the administered dose of a drug that enters the systemic circulation for a given route of administration. Bioequivalence, on the other hand, refers to the equivalence in bioavailability and pharmacokinetic characteristics of two or more drug formulations. Specifically, bioequivalence studies are usually conducted in a randomized crossover design, in which all subjects take the two drug formulations to be tested sequentially, separated by a washout period. This eliminates the influence of individual differences between subjects on the results. During the course of the study, the concentration profiles of the active ingredients in the plasma of the subjects are measured as a function of time, and key parameters such as maximum concentration (Cmax) and area under the curve (AUC) are compared. If the differences between the two preparations in these bioavailability and pharmacokinetic parameters are not significant, they can be considered bioequivalent, i.e., equivalent in terms of clinical efficacy.

Explore Our Bioavailability and Bioequivalence Evaluation Services for Nucleic Acid Drugs

CD Formulation's experienced team of drug developers and pharmacokinetic scientists have extensive expertise in all phases of bioequivalence and bioavailability studies. Moreover, our bioequivalence and bioavailability team collaborates closely with our skilled bioanalytical scientists, statisticians, and regulatory professionals to comprehensively support all facets of our clients' bioequivalence and bioanalytical programs.

Bioequivalence Study Design

When designing a bioequivalence study, consideration should be given to assessing drug absorption and differentiating between different formulations. Bioequivalence studies are often conducted using a two-way, single-dose, crossover design with randomized assignment of sequences, as it limits possible interference from patient-specific factors. Longer washout periods should be planned when using a crossover design.

Bioequivalence Studies for Various Drug Formulations

Our in-house bioanalytical laboratory can quickly and reliably analyze samples obtained from bioequivalence and bioavailability studies. We can professionally and efficiently conduct the following bioequivalence studies:

• Solid oral formulations (tablets, capsules, softgels, sprays, etc.)
• Parenteral formulations
• Topical transdermal products such as patches, creams, ointments, and solutions.
• Inhalation formulations
• Nasal and oral sprays
• Rectal preparations (suppositories and foams)
• Vaginal preparations (tablets, creams, gels)
• Long-acting injectables

Bioavailability Evaluation

Services for evaluating the bioavailability of nucleic acid drugs may include pharmacokinetic studies of the drug, which are a crucial step in assessing the processes of absorption, distribution, metabolism, and excretion of the drug in the body. These studies offer insights into the behavioral properties of nucleic acid drugs in vivo to enhance their efficacy and safety.

Our Technology Platform for Bioavailability and Bioequivalence Evaluation

Our in-house laboratory is equipped with a modern liquid chromatography tandem mass spectrometry (LC/MS/MS) platform for the analysis of various matrices. We are constantly developing innovative LC-MS/MS-based assays to fulfill our customers' specific bioanalytical requirements.

Our Workflow for Bioavailability and Bioequivalence Evaluation Services

Fig.1 Flow chart of bioavailability and bioequivalence evaluation services for nucleic acid drugs. (CD Formulation)

Why Choose Us for the Assessment of Bioavailability and Bioequivalence?

• Efficient and Effective Study Execution
  Our talented team of pharmacokinetic scientists, clinical operations experts, and clinical researchers work together to ensure that bioequivalence and bioavailability studies are conducted in a timely and efficient manner in accordance with the principles of good clinical practice.
• Rigorous Quality Control
  Our quality assurance specialists and quality control processes ensure the acquisition of high-quality scientific data and the excellence of the clinical studies and bioequivalence studies conducted.
• Statistical Support
  Our team of experienced biostatisticians provides superior biostatistical services and programming support for successful bioavailability and bioequivalence studies and our clients' nucleic acid drug development programs.

Publication Data

CD Formulation has extensive experience in designing and implementing bioequivalence and bioavailability studies, including trial design, recruitment, implementation, bioanalysis, statistical analysis, meeting bioequivalence criteria, and regulatory support. Contact us to customize a professional solution for your project.

How It Works

STEP 1

Submit a service request describing your specific research or development need.

STEP 2

We'll email you to provide your quote and confirm order details if applicable.

STEP 3

Execute the project with real-time communication, and deliver the final report promptly.