Pharmacokinetic Studies of Generic Drug

Generic drugs that are pharmaceutically equivalent and bioequivalent to the RLD can be considered therapeutically equivalent. Products with therapeutic equivalence can be substituted for each other without any dose adjustment or additional therapeutic monitoring.

For drugs that are absorbed into the systemic circulation and act throughout the body, bioequivalence evaluation with pharmacokinetic end points as indicators has proved to be most applicable in terms of accuracy, precision, and reproducibility. Pharmacokinetics is the study of drug interactions in the body from release to absorption. The commonly used pharmacokinetic parameters include area under the curve (AUC), concentration to peak (Cmax), time to peak (Tmax), etc. These parameters related to the degree and speed of absorption can evaluate the dynamic process of release and absorption of active ingredients into the systemic circulation.

Fig. 1. Drug plasma concentration over time. (Roy,Jiben, 2011)

Our Services

Pharmacokinetic studies are a key component of generic drug registration documentation. However, the design and implementation of pharmacokinetic studies can be complex and challenging, requiring the expertise of a multidisciplinary team including pharmacokinetics scientists, bioanalytical scientists, and biostatisticians, as well as the use of state-of-the-art bioanalytical facilities.

Our company focuses on comprehensive research into generic drugs, providing services covering the whole process from development to final submission. Alfa Chemistry provides a full range of BE management services from feasibility assessment to clinical study report submission in accordance with the regulations of the local regulatory authorities of our clients.

Project design

Senior scientists in our company first communicate with our client about the project in detail, assess the feasibility of the project for BE study with pharmacokinetic endpoints as indicators, and jointly decide on the trial protocol.

• Overall design

Our company designs pharmacokinetic studies primarily in a crossover design, with the option of using a parallel-group design under certain circumstances (e.g., for drugs with a long half-life).

• Preliminary experiment

A pilot study may be conducted on a small number of subjects to validate assay methods, assess variability, optimize sampling timing, and obtain other relevant information before formal trials begin.

• Subjects and sample size

We estimated the required sample size according to the project, and determined the gender, age, health status, and other requirements of the subjects according to the regulations of regulatory agencies to ensure adequate test power.

• Postprandial BE study

In addition to the fact that the RLD label explicitly states fasting consumption, fasting and postprandial bioequivalence studies are usually required, because taking food with a drug may affect the bioavailability of a drug.

Samples test

Pharmacokinetics tests of our generic drugs measure the concentration of the active ingredient of the drug or its metabolites in volunteer biological samples (e.g., whole blood, plasma, serum, or other biological samples) as a function of time to reflect the rate and extent of drug release and absorption into the circulation. If it is difficult to determine the target substance in biologicalmatrices such as blood, plasma, or serum, bioequivalence studies can also be performed by measuring the drug concentration in urine.

Our company provides time-saving, low-cost and highly reproducible sample pretreatment solutions. Our pharmacokinetic research platform has comprehensive detection systems and instruments, such as triple quadrupole mass spectrometry, etc. Our team of experts will select high-throughput, specific and accurate analytical methods based on the customer's product characteristics.

Statistical analysis

We usually employ the pharmacokinetic end points Cmax and AUC to evaluate the speed and extent of drug absorption, and then determine whether the customer's generic product and the selected RLD are therapeutically equivalent through statistical comparison.

Summary report

Our company has a professional application writing team. The pharmacokinetic study summary report offered by Alfa Chemistry provides detailed descriptions of the randomness of the trial, statistical methods, statistical analysis results and other content, which meets the regulatory requirements for generic drug applications.