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What is IND in New Drug Research?

2021-08-20
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IND

Full English name: Investigational New Drug

The FDA new drug review process includes two processes: IND application for new drug clinical trial application and NDA application for new drug application. IND is for clinical trial application, and NDA is for new drug marketing application.

Medicilon provide the IND filing for the preclinical services. Medicilon could submit the application for both US FDA and CFDA for your new drug. Medicilon is the first CRO to offer preclinical animal testing service for the global pharmaceutical companies in China. Medicilon is the CRO that fulfill both the Chinese and US GLP standards. Since 2004, we have successfully helped our clients to submit their new drug application to US FDA and CFDA and met the requirements of the US FDA and CFDA. We have undergone several inspections and passed all of them.  Medicilon will provide an efficient, cost-effective and professional service to help our clients to achieve their goals.

IND application for clinical trials

The main purpose of the IND is to provide sufficient information to prove that the drug is safe to be tested in humans and to prove that the design of the clinical program for research purposes is reasonable. The IND mainly includes phase I, II, and III clinical trial applications. The phase I and II clinical trials are the initial clinical trials, which are the exploratory stage of efficacy; the phase III clinical trials are the expanded clinical trials, which are the verification stage of the efficacy. After the clinical trial IND is approved, applicants can submit an application for expanded clinical trial.

During the IND application stage, the FDA generally stipulates (at a minimum) that drug sponsors must:

(1) Do the pharmacological research of the drug;

(2) Carry out acute toxicity test on at least two kinds of animals;

(3) Conduct a short-term study of two weeks to three months according to the intended use of the drug. Once the pre-clinical research is over, the animal test is not over and then completed. Many longer and more specialized studies such as chronic and anti-cancer tests will be carried out throughout the new drug application process.

Preclinical studies are used to evaluate:

(1) Pharmacological phenomena and mechanism of action (MOA) of drugs;

(2) Drug toxicity characteristics and toxicity target organs;

(3) Drug absorption, distribution, metabolism and excretion (ADME). When the drug sponsor believes that it has sufficient data to prove that the drug is safe, it can prepare to submit a new drug clinical investigation application (IND) to the FDA.

In essence, the IND is just a suggestion. Through this suggestion, the drug sponsor obtains the permission of the FDA to start testing on humans.

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IND Enabling Studies FDA


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