In Vivo ADME
Drug development is a high-risk, high investment, but also a high reward process. The earlier in the process the ADME properties are evaluated and selected, the sooner those compounds with poor ADME characteristics can be eliminated in time, and the unnecessary investment and waste of resources in the later stage can be reduced. BOC Sciences can provide you with in vivo ADME studies and can design experimental protocols to meet your specific needs and help you in your drug development process.
Introduction
ADME stands for absorption, distribution, metabolism and excretion and represents the process of drug disposal by the body after entry into the organism. These four properties determine the concentration, tissue distribution and metabolic pathway of a drug in the body and are important for predicting the bioavailability and bioactivity of a drug (i.e. whether a drug will reach its target and produce the corresponding therapeutic effect). Therefore, understanding the ADME properties of a compound is of great importance to the drug development process.
Although radiolabeled and non-radiolabeled in vivo ADME studies are not required as part of an IND package, the information generated may be important in explaining relative clinical safety/risk to various regulatory agencies. Alternatively, if the data are not critical to the IND process, these studies can be performed later in development as they are required for NDA filing.
Study Design Options
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BOC Sciences' In Vivo ADME Services
In vivo PK mainly studies the law of drug concentration in vivo changing with time. The main pharmacokinetic parameters of the subject are derived from the blood concentration-time data measured in the test for each animal. For intravenous administration, t1/2 (elimination half-life), Vd (apparent volume of distribution), AUC (area under the C-tcurve) and CL (clearance) should be provided; for extravascular administration, in addition to these parameters, Cmax and Tmax (time to peak) should be provided to reflect the pattern of drug absorption. In addition, providing statistical moment parameters, such as MRT (mean residence time), AUC(0-t) and AUC(0-∞), etc., are also meaningful for describing the pharmacokinetics of drugs.
Mass balance experiments can provide important information such as clearance rates and clearance pathways for new drug candidates. Mass balance studies are also an important part of the application to regulatory authorities. Various mass balance studies can be performed using mice, rats and dogs.
QWBA is a powerful tool for analyzing the tissue distribution of subjects, with the absolute advantages of high resolution, full range of substances, full range of tissues, full-time span, and quantifiability. It enables immediate and accurate identification of subject-related target organs. It allows more comprehensive prediction of clinical risk and scientific estimation of clinical radioactive dosing before clinical trials are conducted.
Human absorption, metabolism, and excretion (human AME) studies, human radiolabel-AME studies, evaluate the pharmacokinetics, mass balance, excretion pathways, and metabolic pathways of the parent drug to ensure that the metabolite profile was comparable to that observed in preclinical ADME studies and to identify any disproportionate or unique human metabolites.
Most drugs bind to plasma proteins (e.g. human serum albumin, lipoproteins, glycoproteins and alpha, beta and gamma globulins) to varying degrees. Weakly acidic drugs bind mainly to albumin, while weakly basic drugs often bind to lipoproteins and acidic glycoproteins, in addition to albumin. Binding of a drug to plasma proteins affects the rate of diffusion, transport, intensity of action, and rate of elimination of the drug.
Radiation monitoring is an essential part of the implementation of good health physics practice in any radiological practice performed in any medical facility. It is a core discipline for RSO, health physicists, medical physicists, radiologists and nuclear medicine technicians to gain insight into patient radiation exposure rates.
Advantages of BOC Sciences
- Advanced Bioanalytical Laboratory
- Experienced, flexible and timely
- Fast project turnaround time
- Cost-effectiveness
BOC Sciences is committed to being a good partner to our global clients. If you are interested in what we can offer, please feel free to contact us and get a quote.