This site uses cookies.
Some of these cookies are essential to the operation of the site,
while others help to improve your experience by providing insights into how the site is being used.
For more information, please see the ProZ.com privacy policy.
English to Chinese: AE General field: Medical Detailed field: Medical: Pharmaceuticals
Source text - English Medical condition/diseases present before starting the investigational drug will be considered adverse events only if they worsen after starting study treatment. Throughout the course of the study, all solicited and unsolicited AEs will be monitored and reported on an AE CRF, including the event’s seriousness, severity, action taken, and relationship to investigational product(s). AEs should be followed until resolution or stable and the outcome will be documented on the appropriate CRF. All AEs should be recorded in standard medical terminology rather than the subject’s own words.
Chinese to English: 细胞培养 General field: Medical Detailed field: Medical: Pharmaceuticals
Source text - Chinese 人感染H7N9禽流感病毒是一种新型甲型流感病毒，其内部基因来自于H9N2等禽流感病毒，从而导致病毒在抗原水平发生了明显改变，并同时具备了感染人体的能力。对于尚无同类产品批准的核酸检测试剂，考虑到病毒分离培养鉴定方法的灵敏度问题，申请人应当采用病毒核酸序列测定方法或者国家公布的检测方法作为参比方法，但用于核酸序列测定的引物序列应不同于考核试剂中用于检测目的基因的引物序列。细胞培养采用流加培养工艺，所用培养基均为无动物源培养基。该工艺主要步骤包括细胞复苏、逐级细胞扩增、细胞流加培养和产品收获。
Translation - English H7N9 avian influenza virus causing human infection is a novel influenza A virus. Its internal genes are derived from avian influenza viruses such as H9N2, which results in significant change in antigen level of the virus, and also makes it have the ability to infect human body. For nucleic acid test reagent without products of the same class have been approved, the applicant should use viral nucleic acid sequencing method or nationally published test method as the reference method considering the problem in sensitivity of virus isolation, culture and identification methods. However, the primer sequence for nucleic acid sequencing should be different from the primer sequence for testing target gene in investigational reagent. The feeding culture process is used for cell culture. All culture media used are animal-free media. The main steps of this process include cell recovery, stepwise cell expansion, cell feeding culture and product harvest.
More
Less
Experience
Years of experience: 14. Registered at ProZ.com: Apr 2022.
As a medical translator with more than 10 years of experience, I am especially good at translating Investigator's Brochures, Patient Records, Protocols, Pharmaceutical Product Information, Clinical Study Report, using Wordfast and Trados softwares.
Keywords: Dedicated Life Sciences Translation, Subject-matter expert, Experienced editor, Rigorous proofreader, Quality Assurance reviewer, Complete Translation Solutions for Clinical Trials, Medical Devices, Drugs
Portfolio