Guidelines and strategy of the International Conference of Harmonization(ICH) and its member states to overcome existing impurity control problems for antibiotics in China

In the present report,we review the technical guidelines and principles on impurity research and control for antibiotics established by various agencies,including the International Conference of Harmonization(ICH),the US Food and Drug Administration(FDA),the European Medicines Agency(EMA) and the China Food and Drug Administration(CFDA).Progresses with the US Pharmacopoeia(USP),the European Pharmacopoeia(EP) and the Chinese Pharmacopoeia(ChP) to control impurities in antibiotics are also presented.Next,our discussion is focused on analyzing the CFDA's requirements on impurity research and control for antibiotics,and the implementation of ICH,FDA and other technical guidelines for generic drugs impurity control in China.Existing problems are further reviewed,in order to improve the overall process for the control of antibiotic

Safety and immunogenicity of a recombinant COVID-19 vaccine(Sf9 cells)in healthy population aged 18 years or older:two single-center,randomised,double-blind,placebo-controlled,phase 1 and phase 2 trials

COVID-19 vaccines from multiple manufacturers are needed to cope with the problem of insufficient supply.We did two singlecenter,randomised,double-blind,placebo-controlled phase 1 and phase 2 trials to assess the safety,tolerability and immunogenicity of a recombinant COVID-19 vaccine(Sf9 cells)in healthy population aged 18 years or older in China.Eligible participants were enrolled,the ratio of candidate vaccine and placebo within each dose group was 3:1(phase 1)or 5:1(phase 2).From August 28,2020,168 participants were sequentially enrolled and randomly assigned to receive the low dose vaccine,high dose vaccine or placebo with the schedule of 0,28 days or 0,14,28 days in phase 1 trial.From November 18,2020,960 participants were randomly assigned to receive the low dose vaccine,high dose vaccine or placebo with the schedule of 0,21 days or 0;14,28 days in phase 2 trial.The most common solicited injection site adverse reaction within 7 days in both trials was pain.The most common solicited systematic adverse reactions within 7 days were fatigue,cough,sore throat,fever and headache.ELISA antibodies and neutralising antibodies increased at 14 days,and peaked at 28 days(phase 1)or 30 days(phase 2)after the last dose vaccination.The GMTs of neutralising antibody against live SARS-CoV-2 at 28 days or 30 days after the last dose vaccination were highest in the adult high dose group(0,14,28 days),with 102.9(95%Cl 61.9-171.2)and 102.6(95%Cl 75.2-140.1)in phase 1 and phase 2 trials,respectively.Specific T-cell response peaked at 14 days after the last dose vaccination in phase 1 trial.This vaccine is safe,and induced significant immune responses after three doses of vaccination.

Lipid-Based Intelligent Vehicle Capabilitized with Physical and Physiological Activation

Intelligent drug delivery system based on “stimulus-response”mode emerging a promising perspective in next generation lipidbased nanoparticle.Here,we classify signal sources into physical and physiological stimulation according to their origin.