Shanghai Medicilon Inc.

  What is the Main Purpose of Preclinical Testing? Pre-clinical testing must be performed before clinical trials. The purpose of pre-clinical trials is to use human cell cultures or animals to evaluate the potential toxicity of a new therapeutic drug before the “in vivo” test is performed by human participants. The main goals of preclinical studies are to determine a starting, safe dose for  first-in-human study  and assess potential  toxicity  of the product, which typically include new  medical devices ,  prescription drugs , and  diagnostics . According to the US Food and Drug Administration (FDA), before a new medicinal drug is approved for use, a series of tests need to be carried out. In the first phase, basic research identifies hypothetical targets to treat a certain disease and then small molecules or biological compounds are screened to find any which show potential to treat the disease. Before the new vaccine can be tested in humans,...

  Preclinical research refers to chemical synthesis or natural product purification research, drug analysis research, pharmacodynamics, pharmacokinetics and toxicology research, and pharmacy research conducted before the drug enters clinical research. Preclinical Trails Content Preclinical research of drugs 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 drugs Generation dynamics and so on. Traditional Chinese medicine preparations also include the source, processing and processing of raw medicinal materials, and biological products also include the source of starting materials, quality standards, storage conditions, biological characteristics, genetic stability, and immunology of bacteria, cell strains, biological tissues, etc. Research and so on. Accor...

In the process of  preclinical testing  of a compound or biological agent into a drug, the compound involved must go through the testing phase. First, we need to identify potential targets that can treat the disease. Then, a variety of compounds or preparations are screened out. Any compound that has shown potential as a drug for the treatment of this disease needs to be tested for toxicity before clinical testing to reduce the possibility of injury. preclinical testing What is the basis of preclinical testing? According to US Food and Drug Administration (FDA) regulations, a series of tests are required before a new drug is approved for use. In the first stage, basic research determines a hypothetical target for the treatment of a certain disease, and then screens small molecules or biological compounds to discover any substance with the potential to treat the disease. Then, a  preclinical research  phase followed, before which, as described above, the potential tox...