Chapter12 PHARMACEUTICALS AND THE ECONOMICS OF INNOVATION

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《中国药典》2020 年版四部通则英文

《我国药典》2020年版四部通则英文1. IntroductionChina Pharmacopoeia is a national standard for the quality control of drugs and medicinal materials in China. It plays a crucial role in ensuring the safety and efficacy of pharmaceutical products and promoting the development of traditional Chinese medicine (TCM). The "China Pharmacopoeia 2020 Edition" consists of four parts, including the General Principles, Traditional Chinese Medicine, Chemical Drugs, and Biological Products. This article will focus on the English translation of the General Principles, which serves as the foundation and standardization of the entire pharmacopoeia.2. History and SignificanceThe General Principles of "China Pharmacopoeia" provide essential guidelines for the identification, quality control, and standardization of drugs and medicinal materials. It covers general requirements, quality standards, testing methods, and labeling requirements for pharmaceutical products. The General Principles 本人m to ensure the safety, effectiveness, and consistency of drugs, which is critical for public health and the development of the pharmaceutical industry. The Englishtranslation of the General Principles is significant for internationalmunication, collaboration, and the globalization of TCM.3. Structure and ContentThe General Principles of "China Pharmacopoeia" consist of several sections, including General Rules, General Tests, and Reagents, Dosage Forms, and Quality Standards. The General Rules section outlines the basic requirements for the quality control of drugs and medicinal materials, covering aspects such as identity, purity, andposition. The General Tests and Reagents section provides det本人led testing methods and reference standards for the analysis of pharmaceutical products. The Dosage Forms section specifies the quality standards and testing methods for various dosage forms, such as tablets, capsules, and injections. The Quality Standards section sets specific requirements for individual drugs and medicinal materials.4. English Translation EffortsThe English translation of the General Principles of "China Pharmacopoeia" is a significant and challenging task. It requires not only proficiency in both Chinese and English languages butalso a deep understanding of pharmaceutical science and regulations. The translation process involves the collaboration of experienced translators, pharmaceutical experts, and regulatory professionals. It also requires extensive review, verification, and validation to ensure accuracy and consistency.5. Importance for InternationalizationThe English translation of the General Principles of "China Pharmacopoeia" is crucial for promoting the internationalization of TCM and enhancing global cooperation in pharmaceutical regulation and standardization. It provides international audiences with access to the fundamental principles and standards of Chinese pharmacopoeia, which facilitates mutual understanding and mutual recognition in drug regulation and quality control. Additionally, the English translation serves as a bridge formunication and exchange between Chinese and international pharmaceutical professionals and regulatory authorities.6. ConclusionIn conclusion, the English translation of the General Principles of "China Pharmacopoeia" 2020 Edition is essential for promoting the standardization, regulation, and internationalization ofpharmaceutical products and traditional Chinese medicine. It represents a milestone in the global recognition of Chinese pharmacopoeia and contributes to the advancement of public health and pharmaceutical industry worldwide.In summary, the "China Pharmacopoeia" 2020 Edition carries significant weight in the internationalmunity, and the process of translating it into English is crucial. This English translation of the General Principles is not only a reflection of China'smitment to global standards, but also a catalyst for promoting the internationalization of traditional Chinese medicine. As the world continues to embrace the principles and standards of Chinese pharmacopoeia, the English translation serves as a vital tool for bridging cultural and linguistic gaps in the pharmaceutical industry.。

药学专业推荐书目

书名著者Pharmaceutics: the science of dosage formdesign， 2nd ed.Michael E. Aulton.Oxford textbook of clinical pharmacology and drug therapy D.G. Grahame-Smith, J.K. AronsonDrug Bioavailability: Estimation ofSolubility, Permeability, Absorption andBioavailabilityvan de WaterbeeBurger's medicinal chemistry and drugdiscovery, 6th ed.Donald. J. Abraham, Pharmaceutical Analysis David C. LeePharmacology: An Introduction, 5th ed.Rang, H. P.Analytical chemistry， 6th ed.Gary D. Christian. Wilson and Gisvold's textbook of organicmedicinal and pharmaceutical chemistry,11th ed.John H. Block,Ansel's pharmaceutical dosage forms anddrug delivery systems, 8th ed.Loyd V. Allen,Netter's illustrated pharmacology Robert B. Raffa,Pharmaceutical analysis：a textbook forpharmacy students and pharmaceuticalchemists，2nd ed.David G. Watson.Theory and practice of contemporarypharmaceuticsTapash K. Ghosh,Basic pharmacology :understanding drugactions and reactionsMaria A. Hernandez,Elsevier's Integrated Pharmacology Kester, MarkGoodman & Gilman's the pharmacologicalbasis of therapeutics.11th ed.Laurence L. Brunton ; Integrated pharmacology, 3rd ed.Clive Page,Martin's physical pharmacy andpharmaceutical sciences, 5th ed.Sinko, Patrick J. Medicinal Chemistry, 3rd ed.Ashutosh KarMedicinal chemistry a molecular andbiochemical approach,3rd ed.Thomas Nogrady,Pharmacology and physiology in anestheticpractice,4th ed.Robert K. Stoelting,Physicochemical principles of pharmacy，4th ed.A.T. Florence Principles of Clinical Pharmacology，2nded.Arthur J. Atkinson Jr.Remington: the science and practice of pharmacy.21th ed.University of the Sciences in PhiladelphiaMedicinal chemistry, 2nd ed.Gareth Thomas.Medical pharmacology: a clinical coretext for integrated curricula with self-assessment， 3rd ed.Peter Winstanley,Pharmaceutics : the design andmanufacture of medicines， 3rd ed/Michael E. Aulton. Rang and Dale's pharmacology, 6th ed.H. P. RangCase files Pharmacology,2nd ed.Eugene C. ToyDrug benefits and risks : internationaltextbook of clinical pharmacology， 2nded.Chris J. vanFoye's principles of medicinalchemistry， 6th ed.Thomas L. Lemke Katzung & Trevor's pharmacology, 8th ed.Anthony J. Trevor, Pharmacotherapy principles and practice Marie A. Chisholm-BurnsPrinciples of pharmacology: thepathophysiologic basis of drug therapy,2nd ed.David E. Golan,Symptoms in the Pharmacy: A Guide to theManagement of Common Illness, 6th ed.Blenkinsopp,A Textbook of Clinical Pharmacology andTherapeutics, 5th ed.James M RitterTextbook of receptor pharmacology, 3rded.John C. Foreman,An introduction to medicinal chemistry,4th ed.Graham L. PatrickBasic and clinical pharmacology, 11th ed.Katzung,Introduction to pharmacology，11th ed.Mary Kaye Asperheim.Lippincott's illustrated reviews : pharmacology 4th ed.Richard Finkel, Michelle A. Clark,Pharmacology condensed, 2nd ed.M.M. Dale,Pharmacology and therapeutics :principles to practiceScott A. Waldman,Roach's Introductory ClinicalPharmacology, 9th ed.Susan, M. Ford,Trease and Evans pharmacognosy， 16th ed.William Charles Evans. The Pharmacologic Principles Of MedicalJohn C. Krantz Jr. Practice V.1-2Basic clinical pharmacokinetics,5th ed.Michael E. Winter.Brody's human pharmacology : bmolecularLynn Wecker,to clinical，5th ed.BRS Pharmacology， 5th ed.Gary C. Rosenfeld,Comprehensive pharmacy review practiceAlan H. Mutnickexams, 6th ed.Introduction to clinical pharmacology,Marilyn Winterton Edmunds. 6th ed.Pharmacology, 3rd ed.George M. Brenner,出版社出版年ISBN索书号Churchill Livingstone 2002443055173TQ460/AME/=2(Y0)Oxford2002192632345R453-43/GSDG/ =3(Y0)Wiley2003352730438X1Wiley2003471370320R914/WME /V1/=6(Y 0)Oxford2003184127335X R917/LDC (Y0)Churchill Livingstone 2003443071454R96/RHP/=5(Y0)Wiley20044712147281 LippincottWilliams & Wilkins 2004781734819R931.6/DRF/=11(Y0)LippincottWilliams & Wilkins 2005781746124R944/AHC/=8(Y0)Saunders20051929007604R96-64/RRB(Y 0)Churchill Livingstone 2005443074453R917/WDG/=2(Y0)CRC Press2005415288630R9/GTK(Y 0)CRC, Taylor & Francis 20069.78159E+12R96/HMA-a(Y0)Mosby20069.78032E+121McGraw-Hill200671422803R96/GAG/ =11(Y0)Mosby20069.78032E+12R96/IP/= 3(Y0)LippincottWilliams & Wilkins 2006078175027XR912/MAN/=5(Y0)Anshan Ltd.20069.7819E+12R914/KA( Y0)Oxford2006195104552R914/NT/ =3(Y0)LippincottWilliams & Wilkins 2006781754690R614/SRK-2/=4(Y0)Pharmaceutical Press 2006085369608XR913/FAT/=4(Y0)Academic Press20069.78012E+121LippincottWilliams & Wilkins 2006781746736R9/GAR/=21(Y0)Wiley20079.78047E+12R914/TG/ =2R(Y0)Elsevier/Churchi ll Livingstone 20079.78044E+12R96/WP-1/=3Churchill Livingstone 20079.78044E+12R9/AME/=3(Y0)Churchill Livingstone 20079.78044E+12R96/RHP/=6(Y0)McGraw-Hill20089.78007E+12R969/TEC /=2(Y0)IOS Press20089.78159E+121 LippincottWilliams & Wilkins 20089.78078E+12R914/FWO/=6(Y0)McGraw-Hill20089.78007E+12R96-44/KBG/= 8(Y0)McGraw-Hill20089.78007E+12R453/CMA (Y0)Wolters Kluwer Health 20089.78078E+12R96/PP/=2(Y0)Wiley20089.78141E+12R97-62/BA/=6 (Y0)Oxford20089.78034E+121CRC Press20089.78142E+12R966-43/FJC/= 3(Y0)Oxford20099.7802E+12R914/PGL /=4(Y0)McGraw-Hill20099.78007E+121Saunders/Elsevie r 20099.78142E+12R96/AMK/=11(Y0)LippincottWilliams & Wilkins 20099.78161E+12R96/RF/=4(Y0)Churchill Livingstone 20099.78044E+12R96-62/DMM/=2(Y0)Saunders20099.78142E+12R969/WSA (Y0)LippincottWilliams & Wilkins 20099.78161E+12R969/FSM/=9(Y0)Saunders20099.7807E+12R93/TGE/ =16(Y0)KessingerPublishing20099.7811E+121 Wolters KluwerHealth/Lippincot t Williams & Wilkins Health 20109.78078E+12R969.1/WME/=5(Y0)Mosby20109.78032E+12R96/BTM/ =5(Y0)Wolters Kluwer Health 20109.78078E+12R96-44/RGC/=5(Y0)LippincottWilliams & Wilkins 20109.78158E+12R9-44/MAH/=7(Y0)Mosby/Elsevier2010323028756R969/EMW /=5(Y0)Saunders20109.78142E+12R96/BGM/ =3(Y0)。

Ch. 12 Food Safety and Tech.

Keep Hot Foods Hot
Keep Hot Foods Hot
Keep Cold Foods Cold
Keep Cold Foods Cold
Always chill prepared or cooked foods in shallow containers, not deep ones.
How Do Micin the Body?
How Do Microbes in Food Cause Illness in the Body?
Staphylococcus aureus – the most common cause of food intoxication
Introduction
Food bioterrorism – the deliberate microbial or chemical contamination of the food supply. USDA’s Food Biosecurity Action Team works to prevent this.
– Infection
• When the microorganism infects the tissues of the human body and multiplies there
– Intoxication
• When the microorganism in the food produces enterotoxins or neurotoxins, poisonous substances that cause harm ranging from stomach pain to death.
Chapter 12: Food Safety and Food Technology

pharmaceutics

Book ReviewEvaluation of Drug Candidates for Preclinical Development: Pharmacokinetics, Metabolism,Pharma-ceutics,and Toxicologyby Chao Han,Charles B.Davis,and Binghe Wang,(Eds.):Wiley Hoboken,NJ, USA2009,ix+289,ISBN978-0-470-04491-9.Price:EUR89.99,USD99.95The laborious and hugely expensive process of taking a lead compound and attempting to develop it into a market-able medicine grows ever more complex and expensive as pharmaceutical com-panies struggle to develop new products, or replace products as they are released from patent protection.Scientiﬁc and technological advancements may open up new roads for drug development,but public perceptions of the industry are often suspicious at best,and made worse by high proﬁle drug recalls as unfa-vourable safety data inevitably mount up.This book,largely written by scien-tists working in the pharmaceutical industry,attempts to provide an insight into how drug development can be im-proved in the early stages by integrating the critical areas in drug design,to minimise costs and drop-out,and more importantly improve safety and eﬃcacy of theﬁnal product.The book is divided into three parts (missing from the contents pages–perhaps to encourage integrated thinking?),con-cerning pharmacokinetics and metabo-lism,pharmaceutics,and predictive safetyassessment.The chapters(2–7)of theﬁrstpart deal with the experimental strategiescurrently used by pharmaceutical scien-tists to screen potential drug candidatesfor characteristics of absorption,distri-bution,metabolism and elimination(known as ADME).Following a veryuseful overview of pharmacokinetics inChapter2,the major physiological factorsaﬀecting the journey of a drug fromadministration to target site are covered insuccessive chapters,and the authors de-scribe mechanisms of such processes insome detail without bogging the readerdown too heavily.The chapter on cyto-chrome P450,the mention of which usu-ally sends students screaming from thelecture theatre,is particularly detailed,butnecessarily so to become meaningful as auseful reference source.Details of experi-mental assays are also included,withillustrative examples.A point well made inthe conclusion of Chapter5is that manyvery useful drugs we have today would notmeet the current stringent pharmacoki-netic criteria for further development andtheir potential would never have beendiscovered.Part2consists of a single butimportant chapter,on the integration ofpharmaceutics into early drug develop-ment.The pharmaceutical industry mayspend a lot of time and money on a leadcompound,only toﬁnd at a late stagethat the physicochemical properties ofthe compound severely hinder furtherdevelopment as a drug.This chapterserves as a reminder of the importanceof considering pharmaceutics in drugdesign programmes.Part3is concerned with safety,anddiscusses the need for better integration oftoxicological studies early in the devel-opment of a lead compound.It focuses onthe major causes of attrition(cardiotox-icity,hepatotoxicity,teratogenicityÁÁÁ)and describes diﬀerent assays and exper-iments which might aid in predicting theseeﬀects,preferably via high-throughputscreening.Perhaps unsurprisingly,elec-trophysiological screening appears highon the list,and an entire chapter is dedi-cated to the importance of drug-inducedlong QT syndrome and its complications.Problematically for the industry,patch-clamping is a highly specialised techniqueand attempts to automate for high-throughput screening remain far fromperfect.As a whole the book is text-heavy,butdiagrams and illustrations,where theyexist,are complementary.All of thechapters cite many recent references,andthe authors appear well aware of thelimitations of the various assays andstrategies discussed.This is a useful ref-erence source for those new to,or aspiringto join the pharmaceutical industry,foracademics,and for students of pharmacyand pharmaceutical sciences.N.C.Henney。

Phytochemical and Pharmacological Properties of the Genus Melodinus

INTRODUCTION
Melodinus is a genus of ca. 53 species in the family Apocynaceae, mainly distributed in tropical and subtropical Asia and from Oceania to the Pacific coast. Among them, ca. 11 species occur in South China, Southwest China and Taiwan [1]. Some species, such as M. suaveolens and M. henyri have been used in Chinese folk medicine for the treatment of meningitis in children, rheumatic heart diseases, diuresis, bone fracture and so on [2,3]. M. scandens is used as a decongestive, agaotitis [4]. In Australia, an aq extract of M. australis, when injected into a dog, produced a sharp drop in blood pressure, accompanied by an increase in the depth of respiration and decrease in rate [5]. Current crude alkaloid mixtures and purified alkaloids from some Melodinus species have demonstrated antitumor

制药工程专业英语课文翻译1 5 11 13 16单元原文加翻译

Unit 1 Production of DrugsDepending on their production or origin pharmaceutical agents can be split into three groups:I .Totally synthetic materials (synthetics)，Ⅱ.Natural products，andⅢ.Products from partial syntheses (semi-synthetic products).The emphasis of the present book is on the most important compounds of groups I and Ⅲ一thus Drug synthesis. This does not mean，however，that natural products or other agents are less important. They can serve as valuable lead structures，and they are frequently needed as starting materials or as intermediates for important synthetic products.Table 1 gives an overview of the different methods for obtaining pharmaceutical agents.1单元生产的药品其生产或出身不同药剂可以分为三类：1。

完全（合成纤维）合成材料，Ⅱ。

天然产物，和Ⅲ。

产品从（半合成产品）的部分合成。

本书的重点是团体的最重要的化合物Ⅰ和Ⅲ一所以药物合成。

这并不意味着，但是，天然产品或其他代理人并不太重要。

它们可以作为有价值的领导结构，他们常常为原料，或作为重要的合成中间体产品的需要。

药学专业英语PPTPPT课件

Notetaking
taking notes on important points and technical terms to aid in comprehension and review.
Classification and characteristics of pharmaceutical English literature
Writing
Writing skills for pharmaceutical English papers
Use appropriate language
Pharmaceutical English is a formal language, so it is important to use appropriate vocabulary and sentence structure. Avoid colloquial language or jargon that may be misinterpreted.
committing to a regular schedule of reading to improve your comprehension and familiarity with pharmaceutical English.
Active review
actively reviewing and summarizing the content you have read to ensure comprehension and retention.
Organize information logically
The structure of the paper should be clear and logical, with a well-defined introduction, methods, results, and conclusion. Each section should flow naturally and build upon the previous one.

中国药典英文索引

中国药典英文索引The Chinese Pharmacopoeia is a comprehensive guide that serves as the authoritative reference for the identification, quality control, and standards of medicines in China. It is a critical resource for professionals in the pharmaceutical industry, ensuring that the standards for the production and use of medicinal products are met.This compendium is updated regularly to reflect thelatest advancements in pharmaceutical science and technology. It encompasses a wide array of traditional Chinese medicines, modern drugs, and their detailed chemical compositions, which are essential for the development of new pharmaceutical products.The English index of the Chinese Pharmacopoeia is particularly valuable for international researchers and practitioners who seek to understand and utilize Chinese medicinal knowledge. It bridges the gap between traditional Chinese medicine and contemporary global health practices.Moreover, the English index facilitates easier access to the pharmacopoeia's content for non-Chinese speakers, promoting the integration of Chinese medicine into international healthcare systems. It is a testament to the growing recognition and influence of Chinese medicine on a global scale.For those looking to delve deeper into the subject, the index is meticulously organized, making it a user-friendlytool for locating specific information on a variety of medicinal substances. It is a testament to the meticulous documentation of China's rich medicinal heritage.In summary, the English index of the Chinese Pharmacopoeia is an essential tool for anyone interested inthe field of medicine, whether they are students, researchers, or practitioners. It opens doors to a wealth of knowledgethat has been accumulated over thousands of years and continues to evolve.。

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medical conditions(~3-‐4 years)
¨
Get approved for sale by FDA or similar body
Bhattacharya, Hyde and Tu – Health Economics
to Phase III
¨
The whole process can cost $500 million or more to bring a drug to the point of approval
Example: Italian government publishes list of maximum permissible prices for each drug ¤ Example: NHS in UK sets the price at which they are willing to purchase drugs (monopsony power)
Patents in developing countries
¨
Low-‐income countries think about this tradeoﬀ diﬀerently
¤ ¤
¤
Monopoly prices weigh more heavily on low-‐income populations Free rider eﬀect: if the US has patent protections, companies will develop new drugs even if there are weak patent protections in India We will see this eﬀect again when we talk about price controls
How do we induce companies to make these costly investments?
Patents create a legal monopoly and hence the opportunity for monopoly proﬁts ¨ In practice, only the top 30% of drugs pay for themselves
¨
Bhattacharya, Hyde and Tu – Health Economics
How strong should patents be?
¨
Downside of stronger patents
¤
Customers have to pay monopoly prices for a longer period ¤ Less incentive for further innovation by same company ¤ Legal barriers to subsequent innovation by another company
¨
Bhattacharya, Hyde and Tu – Health Economics
DRUG DEVELOPMENT
Ch 12 | Pharmaceuticals and the economics of innovation
¤
¨
Controls reduce incentive for research
¤
Tradeoﬀ between access to existing drugs and incentives to develop new ones, same as patent tradeoﬀ
The life cycle of a drug
Once the drug is approved for sale, the drug company has a temporary legal monopoly protected by a patent (17 years in the US) ¨ This is the company’s chance to recoup the millions of dollars spent on testing ¨ After that time is up, other companies can produce the same drug cheaply and proﬁts decrease sharply
CHAPTER 12 PHARMACEUTICALS AND THE ECONOMICS OF INNOVATION
Bhattacharya, Hyde and Tu – Health Economics
Bhattacharya, Hyde and Tu – Health Economics
Drug development is costly
¨
Hard to ﬁnd a promising chemical in the ﬁrst place
¤ Only 21.5% of drugs that enter Phase I pass
Bhattacharya, Hyde and Tu – Health Economics
PATENTS
Ch 12 | Pharmaceuticals and the economics of innovation
Bhattacharya, Hyde and Tu – Health Economics
Aerie
Bhattacharya, Hyde and Tu – Health Economics
Intro
The pharmaceutical industry got its start in 1899, when Bayer, a German chemical company, introduced a painkiller called aspirin ¨ Today, the pharmaceutical industry is massive but tightly regulated ¨ This industry is an ideal setting to study both the economics of innovation and the economics of regulation.
The life cycle of a drug
Find chemical compound that might treat a disease ¨ Then, test it on animals to show it is not toxic ¨ Then, test on humans in three phases
Bhattacharya, Hyde and Tu – Health Economics
Price controls
¨
Price ceilings set or negotiated by the government
¨
¤ Phase 1: low dose to healthy individuals (~2 years) ¤ Phase 2: dose to unhealthy individuals (~2 years) ¤ Phase 3: test eﬀectiveness in preventing disease or
¨
But if patents are too weak, no incentive to develop new drugs!
Bhattacharya, Hyde and Tu – Health Economics
¨
Price discrimination
¤ ¤
In theory, drug companies could sell their drugs for diﬀerent prices in diﬀerent countries In practice, black-‐market importation makes this impossible
¨
Bhattacharya, Hyde and Tu – Health Economics
THE LIFE CYCLE OF A DRUG
Ch 12 | Pharmaceuticals and the economics of innovation