Registration Clinical Research Technical Requirements to the Influenza Virus Nucleic Acid Detection Reagents

Chinese Journal of Pharmacovigilance ›› 2012, Vol. 9 ›› Issue (6): 340-343.

• Orginal Article • Previous Articles Next Articles

Registration Clinical Research Technical Requirements to the Influenza Virus Nucleic Acid Detection Reagents

LI Yao-hua

Center for Medical Device Evaluation, SFDA, Beijing 100044, China

Received:2012-02-17 Online:2012-06-10 Published:2015-08-10

Abstract

Abstract: Based on the characteristic of influenza virus prevalence trend, related regulations and assay reagents, this article illustrated the clinical trial design requirements for influenza virus nucleic acid detection reagent registration. Ethical issues, protocol design, comparative method, study site, statistical analysis and clinical trial report were all involved and provided guidelines for the specific reagent registration.

Key words: influenza virus, in vitro diagnostic, clinical trial

LI Yao-hua. Registration Clinical Research Technical Requirements to the Influenza Virus Nucleic Acid Detection Reagents[J]. Chinese Journal of Pharmacovigilance, 2012, 9(6): 340-343.

[1]	LIU Min, CHEN Yan, LIU Wendong, WANG Haixue. Updates and reflections on expedited reporting of safety information during drug clinical trials [J]. Chinese Journal of Pharmacovigilance, 2024, 21(1): 98-101.
[2]	MA Ruize, CHEN Zhihai. The latest progress of small molecule anti-SARS-CoV-2 drugs [J]. Chinese Journal of Pharmacovigilance, 2023, 20(9): 961-966.
[3]	SHEN Yanjie, WU Yiqing. Management of adverse events during clinical trials [J]. Chinese Journal of Pharmacovigilance, 2023, 20(9): 982-986.
[4]	LIU Wendong, CUI Huanhuan, WANG Xiaohan, SU Xian, WANG Haixue. Status and thinking of Parmacovigilance regulatory system during clinical trials of the pediatric drug in China [J]. Chinese Journal of Pharmacovigilance, 2023, 20(9): 1002-1006.
[5]	BAO Lei, GENG Zihan, GUO Shanshan, YAO Rongmei, SUN Jing, CUI Xiaolan. Effect of Reyanning Heji on animal models of respiratory infectious inflammation [J]. Chinese Journal of Pharmacovigilance, 2023, 20(3): 241-247.
[6]	DENG Yurong, SUN Jianhui, HAO Liyu, SHAN Zhongchao, YU Zeyue, LI Jianliang, HUO Hairu, LI Qijing, ZHANG Hongmeng, LI Hongmei. Therapeutic effect and mechanism of Bairui granules against influenza virus-induced viral pneumonia in mice [J]. Chinese Journal of Pharmacovigilance, 2023, 20(11): 1249-1255.
[7]	ZHANG Jingsheng, GAO Shuangrong, PANG Bo, BAO Lei, SUN Jing, CHEN Mengping, XU Yingli, CAO Shan, GUO Shanshan, ZHAO Ronghua, CUI Xiaolan. Pharmacological effects of Jinzhen oral liquid against viral pneumonia in mice infected with influenza H1N1/FM1 and parainfluenza virus [J]. Chinese Journal of Pharmacovigilance, 2023, 20(1): 46-51.
[8]	MU Sicong, WANG Zhuo, LU Junyang, JI Liwei, LIU Xin. Effects of pioglitazone on plasma adiponectin in patients with type 2 diabetes mellitus: a Meta-analysis [J]. Chinese Journal of Pharmacovigilance, 2022, 19(9): 1015-1018.
[9]	LIU Min, PEI Xiaojing, WANG Haixue. Problems with and suggestions about expedited reporting of suspected unexpected serious adverse reactions during clinical trials of drugs in China [J]. Chinese Journal of Pharmacovigilance, 2022, 19(2): 176-179.
[10]	CUI Huanhuan, PEI Xiaojing, LI Yanrong, LIU Wendong, WANG Haixue, LAN Gongtao, WANG Tao. The practice and consideration of pharmacovigilance during clinical trials in China [J]. Chinese Journal of Pharmacovigilance, 2022, 19(10): 1050-1054.
[11]	ZHAO Zhe, ZHANG Qing, GE Ziruo, ZHANG Wei, CHEN Zhihai. Giant progress in small molecule antiviral drugs for SARS-CoV-2 [J]. Chinese Journal of Pharmacovigilance, 2022, 19(1): 1-6.
[12]	CONG Duanduan, ZHAO Fei, XUE Wei, LI Kexin, HU Xin. Clinical Research of COVID-19 Based on Good Clinical Practices for Clinical Trials of Drugs [J]. Chinese Journal of Pharmacovigilance, 2021, 18(2): 101-104.
[13]	MA Jing, GAO Jinghong, LIU Chunguang. Issues Related to Expanded Access to Investigational Drugs for Compassionate Use [J]. Chinese Journal of Pharmacovigilance, 2021, 18(1): 47-51.
[14]	PENG Shirong, CHEN Haiyan, WANG Qian, DING Qian, WANG Xiaoling. Risk Management of Pediatric Drug Clinical Trials [J]. Chinese Journal of Pharmacovigilance, 2020, 17(9): 564-566.
[15]	DING Lijuan, YIN Lu, WANG Liping, SUN Yaya, HU Bo, LIU Xiaoyun, SUN Yi, LI Wei. Consistency of Case Evaluation of Adverse Event Adjudications in Various Clinical Studies [J]. Chinese Journal of Pharmacovigilance, 2020, 17(9): 625-630.

Registration Clinical Research Technical Requirements to the Influenza Virus Nucleic Acid Detection Reagents

PDF (PC)

Knowledge

Abstract

Cite this article

share this article

References

Related Articles 15

Recommended Articles

Metrics