PREPARATION A LORAL
准备FDA认证前检查Preparing for FDA Preapproval Inspections中英文对照
History of Business企业历史
When was it founded? By whom? 什么时候成立？由谁创建？ Important milestones during company development 公司发展中的重要里程碑
Site changes 网站的变化 Addition of buildings, purchase of major equipment 此外还有建筑物，主要设备的采购 Product introductions 产品介绍
可能会要求更多的信息
Richard Needham, RFL Associates 5
Flow of the pre-Approval Inspection 认证前检查流程
FDA Personnel Involved FDA涉及人员
Two people are usually involved: 通常涉及两个人 FDA Investigator (Production issues) FDA调查人员（生产问题） FDA Chemist (Laboratory Issues) FDA化验师（实验室问题） Generally, they will work separately 一般来说，他们将分开工作 Therefore, preparation for two people is needed 因此，需要配备两个人
3
The Pre-Approval Inspection (PAI)
认证前检查（PAI）
When is the DMF reviewed by FDA? DMF什么时候被FDA审查？
Only after the ANDA holder files the ANDA and refers to the DMF 只有在ANDA持有人将ANDA归档并提交到DMF后 If no ANDA is filed, the DMF is filed away without review. 如果ANDA没有归档，那么DMFjiang将其移开不进行审查。
2024版English grammar preposition courseware
A position is a word that expresses the relationship between a noun or pronoun and other words in a sense It typically indicates direction, location, or time
Positions and other
04 parts of speech settlements
Positions and verb settlements
Common verb+position settlements
01
e.g., "depend on," "rely on," "insist on"
usage
contents
目录
• Positions and other parts of speech settlements
• Precautions for using positions • Summary and Practice
01 Overview of positions
Definition and Function
They can also be used to express relationships between nouns or to provide additional information about a verb's action
Understanding the function of preliminary phrases is essential for improving grammar and writing skills in English
Amphotericin B 溶液说明书
Amphotericin B solution Catalog Number A2942Storage Temperature –20 °C CAS RN 1397-89-3Product DescriptionMolecular Formula: C 47H 73NO 17Molecular Weight: 924.08Melting Point: >170 °C with decompositionλmax :1406 nm, 382 nm, 363 nm, 345 nm (MeOH)Amphotericin B, many times referred to as Fungizone ™, is an antimycotic. Normal usage is 2.5 mg/L along with the addition of penicillin and streptomycin to themedium. This product is used at 10 mL/L of medium. Amphotericin B is stable in culture at 37 °C up to 3days. To kill yeast and fungi, it is recommended to use this product at 2–4 times the normal level (20–40 mL/L) in medium without penicillin andstreptomycin, for 2–3 subcultures. Then, return the cells to normal medium conditions. In the meantime, clean the incubator with SigmaClean water bath cleaner (Catalog Number S5525) and in addition, add this cleaner to the water reservoir to prevent recontamination.This product is supplied as 250 µg/mL Amphotericin B in deionized water. This product is a solution containing Amphotericin B with the following components added to improve its solubility:sodium deoxycholate, sodium chloride, and sodium phosphate.Precautions and DisclaimerThis product is for R&D use only, not for drug,household, or other uses. Please consult the Safety Data Sheet for information regarding hazards and safe handling practices.Preparation InstructionsAlthough the specification for this item is a clear, yellow solution, it is not unusual for this material to form a precipitate in aqueous solutions. Many times,thoroughly mixing the solution will redissolve most of the precipitate. However, this precipitate will probably not fully resolubilize, but the amphotericin B should still be suitable for use.Storage/StabilityStable for 3 days in culture at 37 °C. Stable at 2–8 °C for 2–3 weeks. For long term stability, solutions should be kept frozen at –20 °C.Reference1.The Merck Index, 10th ed., Entry# 611.Fungizone is a trademark of E. R. Squibb and Sons, L.L.C.DS,CMH,SAG,MAM 11/15-1©2015 Sigma-Aldrich Co. LLC. All rights reserved. SIGMA-ALDRICH is a trademark of Sigma-Aldrich Co. LLC, registered in the US and other countries. Sigma brand products are sold through Sigma-Aldrich, Inc. Purchaser must determine the suitability of the product(s) for theirparticular use. Additional terms and conditions may apply. Please see product information on the Sigma-Aldrich website at and/or on the reverse side of the invoice or packing slip.。
preparation英文作文
preparation英文作文下载温馨提示:该文档是我店铺精心编制而成，希望大家下载以后，能够帮助大家解决实际的问题。
文档下载后可定制随意修改，请根据实际需要进行相应的调整和使用，谢谢!并且，本店铺为大家提供各种各样类型的实用资料，如教育随笔、日记赏析、句子摘抄、古诗大全、经典美文、话题作文、工作总结、词语解析、文案摘录、其他资料等等，如想了解不同资料格式和写法，敬请关注!Download tips: This document is carefully compiled by theeditor. I hope that after you download them,they can help yousolve practical problems. The document can be customized andmodified after downloading,please adjust and use it according toactual needs, thank you!In addition, our shop provides you with various types ofpractical materials,such as educational essays, diaryappreciation,sentence excerpts,ancient poems,classic articles,topic composition,work summary,word parsing,copyexcerpts,other materials and so on,want to know different data formats andwriting methods,please pay attention!Preparation is key to success. Whether it's for a job interview, a presentation, or a big event, being prepared can make all the difference. So, how do we prepare? Well, there are many ways to go about it.Firstly, it's important to do your research. Whether you're preparing for a test or a meeting, knowing the subject matter is crucial. You can read books, search the internet, or talk to experts in the field. The more knowledge you have, the better prepared you'll be.Next, practice makes perfect. If you have a presentation coming up, rehearse it multiple times. Practice in front of a mirror or with a friend. This will help you become more comfortable with the material and improve your delivery. Similarly, if you have an interview, practice answering common questions. This will help youfeel more confident and prepared on the day.Another aspect of preparation is organization. Make a to-do list or create a schedule to keep track of what needs to be done. This will help you stay focused and ensure that you don't forget anything important. Additionally, gather all the necessary materials or resources you'll need in advance. Being organized will save you time and stress in the long run.In addition to research and practice, it's important to take care of yourself before any big event. Get enough sleep, eat a healthy meal, and take some time to relax. When you're well-rested and nourished, you'll be able to perform at your best. Don't forget to also take care of your mental well-being. Find ways to manage stress, such as meditation or exercise. Taking care of yourself will help you stay focused and calm during any high-pressure situation.Lastly, be adaptable. No matter how well you prepare, things may not always go according to plan. It's important to be flexible and ready to adjust if needed. Have a backup plan or alternative solutions in mind. Being able to adaptto unexpected situations will show your resilience and ability to think on your feet.In conclusion, preparation is essential for success. By doing research, practicing, staying organized, taking care of yourself, and being adaptable, you'll be well-prepared for any situation that comes your way. So, start preparing now and watch as your confidence and success soar.。
PREPARATION OF ROAST ADLAY
专利名称：PREPARATION OF ROAST ADLAY 发明人：AIBA TOMIO申请号：JP3520081申请日：19810313公开号：JPS57150354A公开日：19820917专利内容由知识产权出版社提供摘要：PURPOSE:To prepare roast adlay having excellent flavor, preventing the degradation of the active components, by roasting polished adlay in hot air stream under fluidized state, and pulverizing the adlay after cooling. CONSTITUTION:Polished adlay seeds are sprinkled with water, and the adlay uniformly moistened to a water content of 5-15% is supplied to the fluidizing bed having straightening vanes at the bottom and roasted at 250-500 deg.C with hot air stream under fluidized state. The temperature of the hot air is preferably 280-350 deg.C, and its flow velocity is 4-9m/sec. The roast adlay is quenched with a ventilation cooler, and pulverized to a desired particle size. If necessary, the powder is seasoned with sugar, salt, or other seasonings. The fine powder can be used as a paste or a drink, and the coarse powder can be used as a raw material of a granular cake, rice-flour cake, millet-and-rice cake, etc. by seasoning, or as a raw material of adlay miso or adlay soy.申请人：HIGETA SHIYOUYU KK更多信息请下载全文后查看。
PERORALLY APPLICABLE PREPARATION CONTAINING HISTAM
专利名称：PERORALLY APPLICABLE PREPARATIONCONTAINING HISTAMINASE OF VEGETABLEORIGIN, RESISTANT TO PEPSIN ANDTRYPSIN AND A PROCESS FOR PRODUCINGIT发明人：SIPKA, Sándor,GYÖRY, Zoltán,BORBÉLY,Jánosné,KERESZTES, Tamás,VÁRNAI,Péter,BÍRÓ, Tamás申请号：EP10763851.2申请日：20100902公开号：EP2611454A1公开日：20130710专利内容由知识产权出版社提供摘要：The subject of the invention is a perorally applicable preparation of vegetable origin, resistant to pepsin and trypsin, based on histaminase, optionally for the use as an agent for improving digestion, reducing appetite or reducing body weight. The preparation of the invention is a pressed juice - which is optionally in lyophilized form -obtained from seedlings of pea (Pisum sativum L.), lentil (Lens culinaris), chick pea (Cicer arietinum), grass pea (Latirus sativus), bean (Phaseolus vulgaris) or field bean (Vicia faba) or - from a mixture of seedlings of the above mentioned plants - which contains histaminase, catalase and protease inhibitor. The subject as well of the invention is the production of the above preparation. ˙申请人：Debreceni Egyetem地址：Egyetem tér 1 4032 Debrecen HU国籍：HU代理机构：Varnai, Aniko 更多信息请下载全文后查看。
有关preparation英语作文
有关preparation英语作文Preparation is the key to success in various aspects of life. Whether it's preparing for a job interview, an important presentation, or even a marathon, the effort and thought put into preparing can make a significant difference in the outcome. The process of preparation involves several steps, each of which contributes to the overall readiness for any challenge or opportunity that comes one's way.The initial phase of preparation is often about gathering information. This could involve researching the company one is interviewing with, understanding the audience for a presentation, or learning about the course for a race. Having comprehensive knowledge allows for a more tailored and effective strategy. It's not just about having the information but understanding it well enough to apply it practically.After gathering information, the next step is planning. This is where one takes the information and crafts a strategy. For an interview, this might mean preparing answers to common questions or highlighting certain aspects of one's experience. For a presentation, it involves structuring the talk to engage the audience and convey the message clearly. In the context of a marathon, it's about creating a training schedule that gradually builds endurance.Practice is an integral part of preparation. It's one thing to have a plan, but another to execute it effectively. Rehearsing for an interview by conducting mock sessions, practicing a presentation multiple times to ensure smooth delivery, or following through with the training plan for a marathon are all forms of practice that refine one's approach and increase confidence.Adaptability is also a crucial element of preparation. Despite the best-laid plans, unexpected situations can arise. Being prepared means having the flexibility to adjust one's strategy when necessary. This could mean changing the focus of an interview answer on the spot, modifying a presentation to better suit the audience's reaction, or altering a training plan due to injury or weather conditions.Finally, mental preparation cannot be overlooked. It's essential to enter any situation with the right mindset. This involves visualizing success, managing stress, and maintaining a positive attitude. Mental preparation helps in staying focused and calm, allowing for better performance.In conclusion, preparation is a multifaceted process that requires diligent information gathering, strategic planning, dedicated practice, adaptability, and mental fortitude. By embracing these components, one can enhance their readiness for any endeavor and increase the likelihood of achieving their goals. The art of preparation is not just about the actions taken but the mindset cultivated, and it is this combination that paves the way for success. 。
A process for the preparation of a lubricating oil
专利名称：A process for the preparation of alubricating oil additive concentrate发明人：Crawford, John,Cane, Charles,O'Connor, Sean Patrick申请号：EP90307916.8申请日：19900719公开号：EP0410648A3公开日：19910320专利内容由知识产权出版社提供摘要：A process for the production of a lubricating oil additive concentrate comprises reacting at elevated temperature the following components:- component (A) a defined acid component (B) - a calcium base added either in a single addition or in a plurality of additions at intermediate points during the reaction, component (C) - at least one compound which is (i) water, (ii) a polyhydric alcohol having 2 to 4 carbon atoms, (iii) a di-‐(C₃ or C₄) glycol, (iv) a tri-(C₂-C₄) glycol, (v) a mono- or poly-alkylene glycol alkyl ether of the formula (I) R(OR¹)OR² (I) wherein R is a C₁ to C₆ alkyl group, R¹ is an alkylene group, R² is hydrogen or a C₁ to C₆ alkyl group and x is an integer from 1 to 6, (vi) a C₁ to C₂₀ monohydric alcohol, (vii) a C₁ to C₂₀ ketone, (viii) a C₁ to C₁₀ carboxylic acid ester, or (ix) a C₁ to C₂₀ ether, optionally, component (D) - a lubricating oil, component (E) - carbon dioxide added subsequent to the, or each, addition of component (B), and component (F) - a compound of formula II R³X (II) wherein X is a halogen and R³ is an alkyl, alkenyl or alkaryl group or halo derivative thereof.申请人：BP CHEMICALS (ADDITIVES) LIMITED地址：Britannic House 1 Finsbury Circus London EC2M 7BA GB国籍：GB代理机构：Fawcett, Richard Fennelly 更多信息请下载全文后查看。