Phase IV clinic trail

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Efficacy and safety of a levonorgestrel entericenteric-coated tablet as an over-theover-thecounter drug for emergency contraception: a Phase IV clinical trial. reference author: Chen, Q-J; Xiang, W-P; Zhang, D-K; QWDWang, R-P; Luo, Y-F; Kang, J-Z; Cheng, L-N RYJLpublication: Human reproduction (Oxford, England) page: 2316-21 year: 2011-Sep 23162011(Epub 2011 Jun 13)
Some new medicine are conducted on patients on trail,which is called phrase IV clinic trail.this can ensure the item is safety and purity.
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Phase 1, are safety and immunogenicity studies performed in a small number of closely monitored subjects. Phase 2 studies are dose-ranging studies doseand may enroll hundreds of subjects. Phase 3 trials typically enroll thousands of individuals and provide the critical documentation of effectiveness and important additional safety data required for licensing. Phase 4 are quite like phase 3.
Phase IV clinic trail
Zhangmengwei Supervisor: Dr.D.A.Egan(ITT,Dublin) NJUT interal class1001
summarize
IV clinic trail is a process that people take this method to check whether the vaccines and other production work or not.
Conclusion
The study found that E-LNG-ECP was E-LNGeffective, safe and well tolerated as an OTC drug. However, an randomized controlled trial should be performed to compare standard LNG tablets with E-LNG-ECP. LNG-
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Methods
A Phase IV clinical trial was conducted in five family planning clinics in China. Women seeking EC within 72 h after unprotected sexual intercourse or contraceptive failure who met the inclusion criteria（内含 criteria（内含 物标准） were recruited. The efficacy of contraception (primary end-point endwas pregnancy rate), side effects (i.e. safety) and the value of E-LNGE-LNGECP for EC were investigated.
Background
An enteric-coated levonorgestrel entericemergency contraceptive pill (E-LNG(E-LNGECP) is an improved formulation, in terms of side effects, which both dissolves and is absorbed in the intestine. Our aim was to evaluate the efficacy and safety of E-LNG-ECP E-LNGas an over-the-counter (OTC) drug for over-theemergency contraception (EC) in Chinese women.
Result
15years) Of 2445 women (aged 15-48 years) who took LNGfollowE-LNG-ECP with follow-up to determine pregnancy, only five pregnancies (0.2%) occurred. The efficacy of contraception was 95.3%. In total, 6.5% of women adverse不利 reported at least one adverse不利 event E-LNGafter taking E-LNG-ECP, and no serious adverse events were reported. Only four (0.16%) vomiting（呕吐） subjects (0.16%) reported vomiting（呕吐）. (月经 月经) The incidence of menstrual (月经)、cycle E-LNGdisturbance was 20.1% after taking E-LNGECP. Subjects who had previously taken (54.4% ECPs (54.4% of these women) rated the acceptability of E-LNG-ECP at 9.36 (on a E-LNG1010-point scale) higher (P<0.05) than the
Until a vaccine is given to the general population, all potential adverse events cannot be anticipated. Thus, many vaccines undergo Phase 4 -formal studies on a vaccine once it is on the market. Also, the government relies on the Vaccine Adverse Event Reporting System (VAERS) to identify problems after marketing begins.
Reference
Document type: Journal Article language: English address: Shanghai Institute of Planned Parenthood Research, Shanghai, PR China.
IV clinic trail is conducted in the last period of production. A sponsor who wishes to begin clinical trials with a vaccine must submit an Investigational New Drug application (IND) to FDA.