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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

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

The research and development of innovative drugs is a long-term process with high investment, high risk and high return. It takes more than ten years on average from early discovery to successful listing, and the cost is as high as more than 1 billion US dollars. Pharmacokinetics (DMPK) research runs through all stages of leadRead more

The competitive ELISA format is based on the binding competition in the initial insulin RIA and IgG EIA methods. The competition between the target analyte from the sample and the reference analyte and the binding of the analyte-specific antibody is the key to this format. Either antibody or target analyte can be labeled with enzymeRead more

All you need to know about the ELISA experiment is here. ELISA, the full name of enzyme-linked immunosorbent assay, is a commonly used immunoassay method; Detection Principle The known antigen or antibody is adsorbed on the surface of the solid phase carrier, the antigen or antibody is labeled with enzyme, and the antigen or antibodyRead more

With the development and progress of antibody technology, the research and development of double antibodies has shown a good development prospect, which is expected to fill the shortcomings of current therapies in some indications. Recently, Medicilon assisted Biotech’s first double antibody (PD-L1/CD47). ) Apply for clinical application. With the development of bi-antibody technology, bi-antibody nowRead more

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“Administrative Measures for Drug Registration” (Bureau Order No. 28) for pre-clinical provisions Article 21 Pre-clinical research of drugs for the purpose of applying for drug registration, including drug synthesis technology, extraction methods, physical and chemical properties and purity, dosage form selection, prescription screening, preparation technology, inspection methods, quality indicators, stability, pharmacology , Toxicology, Animal pharmacokineticsRead more