ABSTRACT
Drug-drug interactions (DDI) change dose-response relationships, and may result in low efficacy or high toxicity, which are important considerations especially in medical practice with multiple-drug therapies. Predicting clinically significant drug interactions during new drug development is an important part of benefit and risk assessment in drug development and review. This article summarizes the purpose and significance of drug interactions in new drug development, the main content and precautions of DDI studies in vivo and in vitro. Drug interaction studies on novel drug approvals for 2020 in the National Medical Products Administration (NMPA) and US Food and Drug Administration (USFDA) are examined, respectively. It aims to provide reference for DDI studies and regulatory reviews in new drug development in our country.
ABSTRACT
This article is to analyse the development of therapeu-tic biologics from 1984 to 2014. Data were obtained from the Drugs @ FDA, PubMed, Embase. com and ClinicalTrail. Gov. Descriptive analyses were used to classify therapeutic biologics by level of innovation,therapeutic category and the chemical na-ture of the drugs. The results showed that from 1996 the thera-peutic biologics entered the fast development period, especially from 2001 to 2005. The 125 therapeutic biologics focus on the treatment of tumor, immune system disease, endocrine and met-abolic diseases, blood system diseases, skeletal muscle system diseases. Antibody has become the dominant of therapeutic bio-logics. Antibody is widely used in the treatment of cancer, di-gestive diseases, immune diseases, respiratory diseases, urinary diseases, skeletal muscle diseases, etc.