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Before the sponsor submits the IND application, the sponsor can request a Pre-IND meeting with the FDA review leader. The main purpose of the meeting is to evaluate and reach consensus on the design of animal research needed to support the first human trial, which can speed up the development of new drugs, effectively shortenRead more

BA/BE Exempted From IND Requirements Not all BA/BEs meet the requirements of IND exemption (that is, there is no need to submit an IND application and perform clinical trials in accordance with IND requirements). For example, BA/BE involving cytotoxic drugs does not meet the requirements of IND exemption. The guidelines followed by the US INDRead more

Let’s Discover the Future of Novel Drugs and Technologies Together! Discovery on Target (DOT) 2021 Discovery on Target (DOT) is an industrial preeminent event on novel drug targets and technologies for drug discovery professionals. DOT highlights advances in the current and emerging “hot” targets and technologies, as well as target validation strategies for the discoveryRead more

Acute Toxicity Test / Repeated Dosing Screening Test Acute toxicity evaluation is one of the basic types of in vivo safety evaluation. Drug registration often requires acute toxicity evaluation. Acute toxicity test data has a special role in safety evaluation, and MTD or MFD can be determined in the initial toxicity description. The data obtainedRead more

Drug safety evaluation plays an extremely important role in the drug development process. As some non-cardiovascular drugs have been found to induce acquired QT prolonged syndrome (LQTS), leading to severe arrhythmia (Torsade de Pointes) , TdP) and after withdrawing from the market, the safety evaluation of the drug on the heart becomes extremely important. TheRead more