ADME

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“ADME” is “drug dynamics”, which refers to the process of the body’s absorption, distribution, metabolism and excretion to xenobiotics. The metabolism and excretion of xenobiotics are elimination, and the process of absorption, distribution, metabolism and excretion may occur simultaneously. The process of drug absorption, distribution and excretion in the body is known as transportation of drug.

The dynamic changes of the drug in animal or human body can be used for reference in the study of pharmacodynamics and toxicology. It is also a guide for new drug research and development.

Modern drug screening laboratories to a large extent depend on the quality and accuracy of early in vivo and in vitro studies in the choice of drug candidates. The expensive cost of research and the rapid pace with which modern pharmaceutical chemists develop new compounds have made a high demand for the early ADME/PK team. In order to broaden the channels for drug development, drug screening laboratories have to gather more information from a large number of new chemical entities (NCE) in a relatively short period of time. As a result, the early ADME/PK team is successful because of the high throughput and quantitative sensitivity derived from the optimization of their compounds.

High throughput drug screening is based on molecular level and cell level of experimental method. It uses the micro plate form as the experimental tool carrier, the automated operating system to to perform the testing process, the fast detecting instrument to detect the experimental data, the experimental data with computer to analyze and process( millions of sample testing at the same time), and the corresponding database to support the overall system operation of the technical system.

Of course, high throughput screening as a method of drug screening is not a panacea, but we should believe that any technological progress will be the promotion of scientific development. Along with the continuous development of high throughput screening, the new technology will play more and more important role in the future research of drug screening, which is the combination of the evaluation criteria and new drug targets.

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In recent years, physiological pharmaceutical model PBPK has been applied more and more no matter in the research and development of new drugs or generic research. FDA, EMA, CFDA and the big pharmaceutical00 companies are introducing modeling and simulation tools to accelerate drug development efficiency. Many scientific research staff feed back PBPK is a very complex model. We often heard at the international conference, but feel very difficult to get started. Here are some experience with the use of the PBPK model. I hope to help you.

Q: What is the significance of PBPK in the development of the pharmaceutical industry?

A: PBPK is important for the development of new drugs, which can be used in all stages of the development of new drugs. In the early new drug development phase: screening, due to the lack of data in the body, it is difficult to choose the compounds with characteristics. With the development of the continuous advance, the focus compound get more and more detailed DMPK characteristics. And PBPK model can be further optimized this time. By comparing the difference of the model, we can further understand the characteristics of the compound DMPK, which is clear in the further exploration which part of the ADME we should focus on. On the other hand, we can predict the next test results based on the optimized PBPK model, which is advantageous to the next step of the experiment design.

Q: How to be familiar with the PBPK model faster and better?

A: Read the relevant literature, build models and optimize models by yourselves. If you do not have programming experience, you’d better use a commercial software such as GastroPlus to build the models. At the same time, you can exchange ideas with your peers.

Q: Where is the deficiency of current PBPK model?

A: There are so many details not enough understood about the process of the drug in the body. So the PBPK model is still rough. We can not accurately predict. So we have to wait a long time before we can see the maturation of PBPK. We are still at the beginning stage. There is one saying: don’t believe it’s result of the forecast, you need to think about it more and more. If you do not verify, it is very dangerous to believe the results of the prediction.

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market

A research aiming to investigate the worldwide ADME-toxicology market situation was carried out in three regions , which are America, Asia Pacific, and EMEA( Europe, Middle East, and Africa ). The research mainly take the revenue made by the sales of products involved in the in vivo and in vitro testing technologies into consideration. After a relatively throughout investigation, it’s estimated that there would be a 10.65% compound annual growth rate during the five years from the present year ( the year of 2015 ) to 2019.

ADME-toxicology products principally including instruments, assays systems, reagents, and software solutions. Besides with revenues generated by these products, the research also considered the companies who are leading in the sales. Agilent Technologies, Bio-rad laboratories, Promega, Sigma Aldrich are key companies in the industry was taken references during the research. Along with those companies are some prominent companies, like Creative-Animodel providing ADME Services, Cytopulse, Entelos and Li-CORE Biosciences etc.

Market drivers are from biotechnology companies, pharmaceutical enterprises and some drug discovery institutes, the business of which will frequently involve in ADME-toxicology tests and related materials, as well as equipment. Absolutely, choosing these companies for references is because that they are the main consumers in the field.

Growing at a 10.65% annual rate is a quite high increasing level for the industry. However, the rate is influenced by many other aspects, among which the most challengable one is the high cost for the advances and innovation in technologies and equipment, remaining a lot of work to be done.

In all, it can be concluded from the research that there will be increasing market shares for enterprises in the future five years but requires the companies themselves to be up-leveled in the advances of both products and services, besides may need them to re-schedule the investment strategies on technology and equipment improvement.

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ADME is the process that drugs take effects at a molecule level once they are absorbed, and it’s the abbreviation of absorption, distribution, metabolism, and excretion, covering the whole course of drug taking effects in the bodies of human and rodent animals. Thus ADME Services will meet a wide range of related biochemical needs. Generally there are in vitro ADME services and in vitro services.

In vivo ADME services require higher on technologies and expertise, as live rodent animals like rats and dog will be involved, while the in vitro services put more stress on the equipment needed in the experiments.

Furtherly, ADME services are classified into two categories, ADME studies support and custom services. ADME studies like physicochemical studies work on the determination of drug molecule properties, including solubility, chemical stability, PMAPA Permeability, aiming to find out the performance of the test agent in any micro-circumstance, then contribute to the drug design process.

Rodent studies are a part of the ADME studies, designed to test the effect that drug will present on the carriers. Furthermore, bioequivalence studies are also under ADME studies, and they are settled to assess the biologically equivalent drug of the test agent.

ADME custom services consist of pharmacokinetic analysis of blood, metabolite isolation and  characterization, bioavailability evaluations, formulation screening and optimization and etc. Pharmacokinetic analysis of blood is to observe the drug effect changes in blood with time variation, and all other services in this category is to better understand the drug properties and performance to present a better final drug with good treatment effect but less side effect and addiction.

ADME studies and services can help the pharmaceutical companies and related research labs from all sides by providing professional support and detailed information in vivo or in vitro from the absorption of drugs to the excretion, and finally assist them in probing more about the property and performance of a drug.

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ADME
What’s ADME

When we talk about ADME, that means four processes taken place when the drug molecule was administered to humans or animals bodies. They are Absorption, Distribution, Metabolism, Excretion, and ADME is the acronym that has been used for decades to describe such studies.

In fact, the ADME affects the drug levels in plasma and tissues, as well as the kinetics of its exposure to the tissues, which influence the performance of the drug.