期刊： THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 2021; 55 (4)
The development of biosimilars has substantially increased in recent years. A biosimilar is a biological product which is highly similar to a licensed......
期刊： THERAPEUTIC INNOVATION & REGULATORY SCIENCE, ; ()
Background The last two decades have witnessed the vigorous development of targeted cancer drugs and the potent therapeutic effects of these drugs hav......
期刊： THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 2020; 54 (1)
Background Computerized detection is a promising method for monitoring adverse drug events (ADEs); however, this method is currently in its infancy an......
期刊： THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 2020; 54 (5)
Background Substance abuse research can raise ethical concerns about the comprehension and decision-making capacities of participants with drug depend......
期刊： THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 2020; 54 (6)
Purpose Effective antiplatelet therapy can significantly reduce the incidence and mortality rate of cardiovascular and cerebrovascular diseases. Aspir......
期刊： THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 2020; 54 (6)
When conducting clinical trials under COVID-19 pandemic, protocol deviations and/or protocol violations are inevitably encountered due to possible env......
期刊： THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 2020; 54 (5)
Two phase-III, double-blind, randomized clinical trials of remdesivir plus SOC (standard of care) versus placebo plus SOC have been conducted in Wuhan......
期刊： THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 2019; 53 (2)
Data quality is critical for clinical trials to obtain robust conclusions about drug safety and efficacy evaluation. Effective data quality evaluation......
期刊： THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 2019; 53 (2)
The surging costs of health care in China is highly related to the high expenses in pharmaceutical costs. Since the Government of China launched the h......
期刊： THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 2019; 53 (2)
Bootstrapping technique is distribution-independent, which provides an indirect way to estimate the sample size for a clinical trial based on a relati......
期刊： THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 2019; 53 (3)
Regulatory inspection of clinical trial is necessary in order for (1) assessing compliance with statutory requirements and regulatory requirement gove......
期刊： THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 2019; 53 (4)
Background: In order to introduce regulatory measures to regulate social media use by the Chinese patent medicine (CPM) companies, it needs better und......
期刊： THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 2018; 52 (4)
Sweeping reforms in the largest markets of the Asia-Pacific region are transforming the regulatory and commercial landscape for foreign pharmaceutical......
期刊： THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 2018; 52 (6)
As the second largest pharmaceutical market with a great potential for future growth, China has drawn much attention from the global pharmaceutical co......
期刊： THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 2022; 56 (4)
Background Currently no reliable tools are available for predicting the risk of central nervous system (CNS) infections in patients with intracerebral......
