chapter 5 nomenclature
As an introduction to the IUPAC nomenclature system, we shall first consider compounds that have no specific functional groups. Such compounds are composed only of carbon and hydrogen atoms bonded together by sigma bonds (all carbons are sp3 hybridized). 5-3 Alkanes Hydrocarbons having no double or triple bond functional groups are classified as alkanes or cycloalkanes, depending on whether the carbon atoms of the molecule are arranged only in chains or also in rings. Although these hydrocarbons have no functional groups, they constitute the framework of other classes of compounds, and provide an ideal starting point for studying and naming organic compounds. The alkanes and cycloalkanes are also members of a larger class of compounds referred to as aliphatic. Simply put, aliphatic compounds are compounds that do not incorporate any aromatic rings in their molecular structure.
Toluene CH3C6H5
Acetylene Ethyl Alcohol C2H2 C2H5OH
Such common names often have their origin in the history of the science and the natural sources of specific compounds, but the relationship of these names to each other is arbitrary, and no rational or systematic principles underly their assignments.
Chapter 5 Nomenclature 5-1 Naming Organic Compounds The number of organic compounds identified is increasing with each passing day (日益）. Also many of these compounds are isomers of other compounds. Fact of above requires that a systematic nomenclature system was developed. Just as each distinct compound has a unique molecular structure which can be designated by a structural formula, each compound must be given a characteristic and unique name. As organic chemistry grew and developed, many compounds were given trivial names（俗名）, which are now commonly used and recognized. Some examples are: Name Methane Butane Acetone Formula CH4 C4H10 CH3COCH3
Some important behavior trends and terminologies: (i) The formulas and structures of these alkanes increase uniformally by a CH2 increment. (ii) A uniform variation of this kind in a series of compounds is called homologous. (iii) These formulas all fit the CnH2n+2 rule. This is also the highest possible H/C ratio for a stable hydrocarbon. (iv) Since the H/C ratio in these compounds is at a maximum, we call them saturated (with hydrogen). Beginning with butane (C4H10), and becoming more numerous with larger alkanes, we note the existence of alkane isomers. For example, there are five C6H14 isomers, shown below as abbreviated line formulas (A through E): Although these distinct compounds all have the same molecular formula, only one (A) can be called hexane. How then are we to name the others?
The IUPAC system requires first that we have names for simple unbranched chains, as noted above, and second that we have names for simple alkyl groups that may be attached to the chains. Examples of some common alkyl groups are given in the following table. Note that the "ane" suffix is replaced by "yl" in naming groups. The symbol R is used to designate a generic (unspecified) alkyl group.
The following table lists the IUPAC names assigned to simple continuous-chain alkanes from C-1 to C-10.
A common "ane" suffix identifies these compounds as alkanes. Longer chain alkanes are well known, and their names may be found in many reference and text books. The names methane through decane should be memorized, since they constitute the root of many IUPAC names. Fortunately, common numerical prefixes are used in naming chains of five or more carbon atoms
5-2 The IUPAC Systematic Approach to Nomenclature A rational nomenclature system should do at least two things. First, it should indicate how the carbon atoms of a given compound are bonded together in a characteristic lattice of chains and rings. Second, it should identify and locate any functional groups present in the compound. Since hydrogen is such a common component of organic compounds, its amount and locations can be assumed from the tetravalency of carbon, and need not be specified in most cases. The IUPAC nomenclature system is a set of logical rules devised and used by organic chemists to circumvent problems caused by arbitrary nomenclature. Knowing these rules and given a structural formula, one should be able to write a unique name for every distinct compound. Likewise, given a IUPAC name, one should be able to write a structural formula. In general, an IUPAC name will have three essential features: A root or base indicating a major chain or ring of carbon atoms found in the molecular structure. A பைடு நூலகம்uffix or other element(s) designating functional groups that may be present in the compound. Names of substituent groups, other than hydrogen, that complete the molecular structure.
跨文化商务沟通 Chapter 5
5.2.2 Ethnocentrism
Parenting style and Interpersonal networking.
Ethnocentrism, which is, negatively judging aspects of another culture by the standard of one’s own culture.
5.2.1 Cultural Differences
• Picture 5
Picture 5 shows different interpersonal relationship Chinese tend to hold a circular social network, thus every dot in the network would have relation with the others, which makes the interpersonal network is pretty intricate. American’s interpersonal networking is relatively simple and straightforward.
5.2.1 Cultural Differences
• Picture 2
Picture 2 shows that Chinese and American display contrary social styles Chinese tend to socialize with each other in the same group Americans adore socializing with each other in isolated small groups
FundamentalsofAerodynamics
Fundamentals of Aerodynamics
Fourth Edition
John D. Anderson, Jr.
Curator of Aerodynamics National Air and Space Museum Smithsonian Institution and Professor Emeritus University of Maryland
பைடு நூலகம்
Contents
xiii
Chapter 4 Incompressible Flow over Airfoils 295 4.1 4.2 4.3 4.4 Introduction 297 Airfoil Nomenclature 300 Airfoil Characteristics 302 Philosophy of Theoretical Solutions for Low-Speed Flow over Airfoils: The Vortex Sheet 307 4.5 The Kutta Condition 312
Inventarisiert unter
TECHWISCHE UNIVERSITAT DARMSTADT
Fachgebiot Konstruktiver Leichtbau und Bauwelsen Prof. Dr.-lng. Helmut Schurmann S4287 Darmstadt, PetersenstraBe 30
187
3.19
3.20 3.21 3.22
190
Incompressible Flow in a Duct: The Venturi and Low-Speed Wind Tunnel 197 Pitot Tube: Measurement of Airspeed 210 Pressure Coefficient 219 Condition on Velocity for Incompressible Flow 221 Governing Equation for Irrotational, Incompressible Flow: Laplace's Equation 222 3.7.1 -. Infinity Boundary Conditions 225 3.7.2 Wall Boundary Conditions 225 Interim Summary 226 Uniform Flow::Our First Elementary Flow 227 Source Flow: O u r Second Elementary Flow 229 : ...; .•,..= :. ....• Combination of a Uniform Flow with a Source and Sink 233 Doublet Flow: Our Third Elementary Flow 237 Nonlifting Flow over a Circular Cylinder 239 Vortex Flow: Our Fourth Elementary Flow 245 Lifting Flow over a Cylinder 249 The Kutta-Joukowski Theorem and the Generation of Lift 262 Nonlifting Flows over Arbitrary Bodies: The Numerical Source Panel Method 264 Applied Aerodynamics: The Flow over a Circular Cylinder—The Real Case 274 Historical Note: Bernoulli and Euler—The Origins of Theoretical Fluid Dynamics 282 Historical Note: d'Alembert and His Paradox 287 Summary 288 Problems 291
经络学总论-中英双语
“经”指经脉，有路径的涵义，它们贯通上下，沟 通内外，是经络系统中的主干。
“Jing” implying pathway refers to meridians that run longitudinally, linking the upper and lower, communicating the interior with the exterior, being the main trunk of the meridian and collateral system.
第一节：经络的基本概念
Section I: the basic concept of meridians and collaterals (Jing luo)
经络是经脉和络脉的总称。
Jing Luo in traditional Chinese medicine is the general term for meridians and collaterals.
经络学说的形成，可能是通过以下途径：
The formation of the meridian and collateral theory may be through following ways:
化学反应工程英文课件Chapter 5
XA 0 XA dXA dXA CA0 0 ( r )(1 X ) ( rA )V0 (1 A XA ) A A A
(5)
化学反应工程
In one form or another, Eqs.2 to 5 have all been encountered in Chapter 3. They are applicable to both isothermal and nonisothermal operations. For the latter the variation of rate with temperature, and the variation of temperature with conversion, must be known before solution is possible. Figure 5.2 is a graphical representation of two of these equations.
accumulati on of A, moles/time
dNA d [ N A0 (1 X A )] dX A N A0 dt dt dt
化学反应工程
By replacing these two terms in Eq.1, we obtain
( rA )V N A 0
rate of loss of reactant A or within reactor due to chemical reaction rate of accumudation of reactant A within the reactor (1)
In the treatment to follow it should be understood that the term V, called the reactor volume, really refers to the volume of fluid in the reactor. When this differs from the internal volume of reactor, then Vr ‘designates(指明,任命) the internal volume of reactor while V designates the volume of reacting fluid. For example, in solid catalyzed reactors with voidage (空 隙率) we have V = Vr For homogeneous systems, however, we usually use the term V alone.
Chapter 5 Thermochemistry
at constant pressure 6-13
Copyright ©The McGraw-Hill Companies, Inc. Permission required for reproduction or display.
Heat of Reaction
Hrxn = Hfinal - Hinitial = Hproducts - Hreactants
SOLUTION:
= -0.776kJ
6-12
Copyright ©The McGraw-Hill Companies, Inc. Permission required for reproduction or display.
The Meaning of Enthalpy
Enthalpy is a thermodynamic function of a system, equivalent to the sum of the internal energy of the system plus the product of its volume multiplied by the pressure exerted on it by its surroundings.
• Heat (q): Energy transferred between a system and its surroundings as a result of a difference in their temperatures only. • Work (w): Energy transferred when a force acts on an object. • Total change in a system’s internal energy ∆E = q + w
新编简明英语语言学Chapter5Semantics语义学
Chapter 5 Semantics 语义学、定义1. semantics 语义学：Semantics can be simply defined as the study of meaning in language. 语义学可以简单地定义为对意义的将研究。
二、知识点5.2 Different views of meaning 意义研究的不同观点521 The naming theory命名论(by 希腊Scholar Plato)The naming theory命名论：Words are just names or labels for thin gs词语只不过是其代表的事物的名字或标记。
Eg. desk—a piece of furniture with a flat top and four legs.The limitations of this theory 局限性：1. This theory seems applicable to nouns only这一理论看起来仅适用于名词(Some words are definitelynot lables of object：eg. jump, quickly, pretty, an d, i n,hearted, thi nk, hard, slowly …)2. There are nouns which denote things that do not exist in the real world： ghost,grago n, un icorn麒麟.有些名词是指世界中根本就不存在的事物。
3. Nouns that do not refer to physical object, but abstract notions such asjoy and impulse有些名词并不是指实物性的物体，而是指：joy, impulse 刺激，这样的抽象概念。
戴炜栋主编英语语言学教程第5章课件 _Syntax
4.2 Categories范畴
4.2.1 Word-level categories Category refers to a group of linguistic items which fulfill the same or similar functions in a particular language e.g. a sentence a noun phrase a verb
4.2.2 Phrase categories and their structure短语范畴及结构
Definition: Phrases refer to the syntactic units which are built around a certain word category. 围绕某一词范畴构成的句法单位
The most central categories to the syntactic study are the word-level categories (traditionally, called parts of speech) .
Here, word-level categories are divided into two kinds: major lexical categories and minor lexical categories.
Noam Chomsky [ˈnoʊm ˈtʃɒmski] (1928--)
---- He is an American linguist, philosopher, cognitive scientist, logician,political commentator and activist, the most influential linguist of the 20th century,and was voted the "world's top public intellectual"(世界顶级公共知识分子) in a 2005 poll. Chomsky has spent most of his career at the Massachusetts Institute of Technology (MIT), where he is currently Professor Emeritus.
chapter 5 Semantics英语专业语言学PPT
Triangle of Reference by Ogden & Richards
Contextualism
3. Contextualism: Meaning should be studied in terms of situation, use, context.
• morning star 启明星 , evening star冥王星
Major sense relations— homonymy 121
• Homonymy 同音/形异义,including: ➢Homophones同音词: rain/reign,
night/night, ➢Homographs同形词:bow v./ n., tear v./
• Linguistic forms having the same sense may have different references in different situations.
• Linguistic forms with the same reference might differ in sense.
5.Reflective/reflected meaning反映义
(association with another sense of the same expression) e.g. intercourse, nucleur
6. Collocative meaning 搭配义 p.116:
• The associations of a word gets because of the meanings of words which tend to occur in its linguistic context.
经典 中英对照 ICH CTD 目录 Module 1, 2, 3, 4, 5
Module 1: Administrative Information and Prescribing Information1.1 Table of Contents of the Submission Including Module1.2 Documents Specific to Each Region (for example, application forms, prescribing information)Module 2: Common Technical Document Summaries2.1 Common Technical Document Table of Contents (Modules 2-5)2.2 CTD Introduction2.3 Quality Overall Summary(QOS) 质量综述INTRODUCTION2.3.S DRUG SUBSTANCE (NAME, MANUFACTURER) 原料药2.3.S.1 General Information (name, manufacturer) 基本信息2.3.S.2 Manufacture (name, manufacturer) 生产2.3.S.3 Characterisation (name, manufacturer) 特性鉴定2.3.S.4 Control of Drug Substance (name, manufacturer) 料药的质量控制2.3.S.5 Reference Standards or Materials (name, manufacturer) 对照品2.3.S.6 Container Closure System (name, manufacturer) 包装系统2.3.S.7 Stability (name, manufacturer).稳定性2.3.P DRUG PRODUCT (NAME, DOSAGE FORM) 制剂2.3.P.1 Description and Composition of the Drug Product (name, dosage form) 剂型及产品组成2.3.P.2 Pharmaceutical Development (name, dosage form) 产品开发2.3.P.3 Manufacture (name, dosage form) 生产2.3.P.4 Control of Excipients (name, dosage form)辅料的控制2.3.P.5 Control of Drug Product (name, dosage form) 制剂的质量控制2.3.P.6 Reference Standards or Materials (name, dosage form)对照品2.3.P.7 Container Closure System (name, dosage form) 包装系统2.3.P.8 Stability (name, dosage form)稳定性2.3.A APPENDICES 附录2.3.A.1 Facilities and Equipment (name, manufacturer) 设施和设备2.3.A.2 Adventitious Agents Safety Evaluation (name, dosage form, manufacturer) 外源因子的安全性评价2.3.A.3 Excipients 辅料2.3.R REGIONAL INFORMATION 区域性信息2.4 Nonclinical Overview2.4.1 Overview of the nonclinical testing strategy2.4.2 Pharmacology2.4.3 Pharmacokinetics2.4.4 Toxicology2.4.5 Integrated overview and conclusions2.4.6 List of literature references2.5 Clinical Overview2.5.1 Product Development Rationale2.5.2 Overview of Biopharmaceutics2.5.3 Overview of Clinical Pharmacology2.5.4 Overview of Efficacy2.5.5 Overview of Safety2.5.6 Benefits and Risks Conclusions2.5.7 Literature References2.6 Nonclinical Written and Tabulated SummariesPharmacologyPharmacokineticsToxicology2.6.1 Introduction2.6.2 Pharmacology Written Summary2.6.2.1 Brief Summary2.6.2.2 Primary Pharmacodynamics2.6.2.3 Secondary Pharmacodynamics2.6.2.4 Safety Pharmacology2.6.2.5 Pharmacodynamic Drug Interactions2.6.2.6 Discussion and Conclusions2.6.2.7 Tables and Figures2.6.3 Pharmacology Tabulated Summary (see Appendix B)2.6.3.1 Pharmacology: Overview2.6.3.2 Primary Pharmacodynamics*2.6.3.3 Secondary Pharmacodynamics*2.6.3.4 Safety Pharmacology2.6.3.5 Pharmacodynamic Drug Interactions*2.6.4 Pharmacokinetics Written Summary2.6.4.1 Brief Summary2.6.4.2 Methods of Analysis2.6.4.3 Absorption2.6.4.4 Distribution2.6.4.5 Metabolism (interspecies comparison)2.6.4.6 Excretion2.6.4.7 Pharmacokinetic Drug Interactions2.6.4.8 Other Pharmacokinetic Studies2.6.4.9 Discussion and Conclusions2.6.4.10 Tables and Figures2.6.5 Pharmacokinetics Tabulated Summary (see Appendix B)2.6.5.1 Pharmacokinetics: Overview2.6.5.2 Analytical Methods and Validation Reports*2.6.5.3 Pharmacokinetics: Absorption after a Single Dose2.6.5.4 Pharmacokinetics: Absorption after Repeated Doses2.6.5.5 Pharmacokinetics: Organ Distribution2.6.5.6 Pharmacokinetics: Plasma Protein Binding2.6.5.7 Pharmacokinetics: Study in Pregnant or Nursing Animals2.6.5.8 Pharmacokinetics: Other Distribution Study2.6.5.9 Pharmacokinetics: Metabolism In Vivo2.6.5.10 Pharmacokinetics: Metabolism In Vitro2.6.5.11 Pharmacokinetics: Possible Metabolic Pathways2.6.5.12 Pharmacokinetics: Induction/Inhibition of Drug-Metabolizing Enzymes 2.6.5.13 Pharmacokinetics: Excretion2.6.5.14 Pharmacokinetics: Excretion into Bile2.6.5.15 Pharmacokinetics: Drug-Drug Interactions2.6.5.16 Pharmacokinetics: Other2.6.6 Toxicology Written Summary2.6.6.1 Brief Summary2.6.6.2 Single-Dose Toxicity2.6.6.3 Repeat-Dose Toxicity (including supportive toxicokinetics evaluation)2.6.6.4 Genotoxicity2.6.6.5 Carcinogenicity (including supportive toxicokinetics evaluations)2.6.6.6 Reproductive and Developmental Toxicity (including range-finding studies and supportive toxicokinetics evaluations)2.6.6.7 Local Tolerance2.6.6.8 Other Toxicity Studies (if available)2.6.6.9 Discussion and Conclusions2.6.6.10 Tables and Figures2.6.7 Toxicology Tabulated Summary (see Appendix B)2.6.7.1 Toxicology: Overview2.6.7.2 Toxicokinetics: Overview of Toxicokinetics Studies2.6.7.3 Toxicokinetics: Overview of Toxicokinetics Data2.6.7.4 Toxicology: Drug Substance2.6.7.5 Single-Dose Toxicity2.6.7.6 Repeat-Dose Toxicity: Non-Pivotal Studies2.6.7.7 Repeat-Dose Toxicity: Pivotal Studies2.6.7.8 Genotoxicity: In Vitro2.6.7.9 Genotoxicity: In Vivo2.6.7.10 Carcinogenicity2.6.7.11 Reproductive and Developmental Toxicity: Non-Pivotal Studies2.6.7.12 Reproductive and Developmental Toxicity – Fertility and Early Embryonic Development to Implantation (Pivotal)2.6.7.13 Reproductive and Developmental Toxicity –Effects on Embryo-Fetal Development (Pivotal)2.6.7.14 Reproductive and Developmental Toxicity –Effects on Pre- and Postnatal Development, Including Maternal Function (Pivotal)2.6.7.15 Studies in Juvenile Animalsa2.6.7.16 Local Tolerance2.6.7.17 Other Toxicity Studies2.7 Clinical Summary2.7.1 Summary of Biopharmaceutic Studies and Associated Analytical Methods 2.7.1.1 Background and Overview2.7.1.2 Summary of Results of Individual Studies2.7.1.3 Comparison and Analyses of Results Across Studies2.7.1.4 Appendix2.7.2 Summary of Clinical Pharmacology Studies2.7.2.1 Background and Overview2.7.2.2 Summary of Results of Individual Studies2.7.2.3 Comparison and Analyses of Results Across Studies2.7.2.4 Special Studies2.7.2.5 Appendix2.7.3 Summary of Clinical Efficacy2.7.3.1 Background and Overview of Clinical Efficacy2.7.3.2 Summary of Results of Individual Studies2.7.3.3 Comparison and Analyses of Results Across Studies2.7.3.3.1 Study Populations2.7.3.3.2 Comparison of Efficacy Results of all Studies2.7.3.3.3 Comparison of Results in Sub-populations2.7.3.4 Analysis of Clinical Information Relevant to Dosing Recommendations2.7.3.5 Persistence of Efficacy and/or Tolerance Effects2.7.3.6 Appendix2.7.4 Summary of Clinical Safety2.7.4.1 Exposure to the Drug2.7.4.1.1 Overall Safety Evaluation Plan and Narratives of Safety Studies2.7.4.1.2 Overall Extent of Exposure2.7.4.1.3 Demographic and Other Characteristics of Study Population2.7.4.2 Adverse Events2.7.4.2.1 Analysis of Adverse Events2.7.4.2.2 Narratives2.7.4.3 Clinical Laboratory Evaluations2.7.4.4 Vital Signs, Physical Findings, and Other Observations Related to Safety2.7.4.5 Safety in Special Groups and Situations2.7.4.5.1 Intrinsic Factors2.7.4.5.2 Extrinsic Factors2.7.4.5.3 Drug Interactions2.7.4.5.4 Use in Pregnancy and Lactation2.7.4.5.5 Overdose2.7.4.5.6 Drug Abuse2.7.4.5.7 Withdrawal and Rebound2.7.4.5.8 Effects on Ability to Drive or Operate Machinery or Impairment of Mental Ability2.7.4.6 Post-marketing Data2.7.4.7 Appendix2.7.5 Literature References2.7.6 Synopses of Individual StudiesModule 3: Quality3.1 Table of Contents of Module 33.2 Body of Data(数据汇总)3.2.S DRUG SUBSTANCE (NAME, MANUFACTURER) 原料药3.2.S.1 General Information (name, manufacturer) 基本信息3.2.S.1.1 Nomenclature (name, manufacturer) 药品名称3.2.S.1.2 Structure (name, manufacturer) 结构3.2.S.1.3 General Properties (name, manufacturer) 基本性质3.2.S.2 Manufacture (name, manufacturer) 生产3.2.S.2.1 Manufacturer(s) (name, manufacturer) 生产商3.2.S.2.2 Description of Manufacturing Process and Process Controls (name, manufacturer) 生产工艺和工艺控制3.2.S.2.3 Control of Materials (name, manufacturer) 物料控制3.2.S.2.4 Controls of Critical Steps and Intermediates (name, manufacturer) 关键步骤和中间体的控制3.2.S.2.5 Process Validation and/or Evaluation (name, manufacturer) 工艺验证和/或评价3.2.S.2.6 Manufacturing Process Development (name, manufacturer) 生产工艺的开发3.2.S.3 Characterisation (name, manufacturer) 特性鉴定3.2.S.3.1 Elucidation of Structure and other Characteristics (name, manufacturer) 结构和理化性质3.2.S.3.2 Impurities (name, manufacturer) 杂质3.2.S.4 Control of Drug Substance (name, manufacturer) 原料药的质量控制3.2.S.4.1 Specification (name, manufacturer) 质量标准3.2.S.4.2 Analytical Procedures (name, manufacturer) 分析方法3.2.S.4.3 Validation of Analytical Procedures (name, manufacturer) 分析方法的验证3.2.S.4.4 Batch Analyses (name, manufacturer) 批分析3.2.S.4.5 Justification of Specification (name, manufacturer) 质量标准制定依据3.2.S.5 Reference Standards or Materials (name, manufacturer)对照品/标准品3.2.S.6 Container Closure System (name, manufacturer) 包装系统3.2.S.7 Stability (name, manufacturer) 稳定性3.2.S.7.1 Stability Summary and Conclusions (name, manufacturer) 稳定性总结和结论3.2.S.7.2 Post-approval Stability Protocol and Stability Commitment (name, manufacturer) 批准后稳定性研究方案和承诺3.2.S.7.3 Stability Data (name, manufacturer)稳定性数据3.2.P DRUG PRODUCT (NAME, DOSAGE FORM) 制剂3.2.P.1 Description and Composition of the Drug Product (name, dosage form)剂型及产品组成3.2.P.2 Pharmaceutical Development (name, dosage form) 产品开发3.2.P.2.1 Components of the Drug Product (name, dosage form) 处方组成3.2.P.2.1.1 Drug Substance (name, dosage form) 原料药3.2.P.2.1.2 Excipients (name, dosage form)辅料3.2.P.2.2 Drug Product (name, dosage form)制剂3.2.P.2.2.1 Formulation Development (name, dosage form)处方开发过程3.2.P.2.2.2 Overages (name, dosage form)过量投料3.2.P.2.2.3 Physicochemical and Biological Properties (name, dosage form)制剂相关特性3.2.P.2.3 Manufacturing Process Development (name, dosage form)生产工艺的开发3.2.P.2.4 Container Closure System (name, dosage form)包装系统3.2.P.2.5 Microbiological Attributes (name, dosage form)微生物属性3.2.P.2.6 Compatibility (name, dosage form)相容性3.2.P.3 Manufacture (name, dosage form)生产3.2.P.3.1 Manufacturer(s) (name, dosage form)生产商3.2.P.3.2 Batch Formula (name, dosage form)批处方3.2.P.3.3 Description of Manufacturing Process and Process Controls (name, dosage form)生产工艺和工艺控制3.2.P.3.4 Controls of Critical Steps and Intermediates (name, dosage form)关键步骤和中间体的控制3.2.P.3.5 Process Validation and/or Evaluation (name, dosage form)工艺验证和/或评价3.2.P.4 Control of Excipients (name, dosage form) 辅料的控制3.2.P.4.1 Specifications (name, dosage form)质量标准3.2.P.4.2 Analytical Procedures (name, dosage form)分析方法3.2.P.4.3 Validation of Analytical Procedures (name, dosage form)分析方法的验证3.2.P.4.4 Justification of Specifications (name, dosage form)质量标准制定依据3.2.P.4.5 Excipients of Human or Animal Origin (name, dosage form)人源或动物源辅料3.2.P.4.6 Novel Excipients (name, dosage form)新型辅料3.2.P.5 Control of Drug Product (name, dosage form)制剂的质量控制3.2.P.5.1 Specification(s) (name, dosage form)质量标准3.2.P.5.2 Analytical Procedures (name, dosage form)分析方法3.2.P.5.3 Validation of Analytical Procedures (name, dosage form)分析方法的验证3.2.P.5.4 Batch Analyses (name, dosage form)批分析3.2.P.5.5 Characterisation of Impurities (name, dosage form)杂质分析3.2.P.5.6 Justification of Specification(s) (name, dosage form)质量标准制定依据3.2.P.6 Reference Standards or Materials (name, dosage form)对照品/标准品3.2.P.7 Container Closure System (name, dosage form)包装系统3.2.P.8 Stability (name, dosage form) 稳定性3.2.P.8.1 Stability Summary and Conclusion (name, dosage form)稳定性总结和结论3.2.P.8.2 Post-approval Stability Protocol and Stability Commitment (name, dosage form)批准后稳定性研究方案和承诺3.2.P.8.3 Stability Data (name, dosage form)稳定性数据3.2.A APPENDICES附录3.2.A.1 Facilities and Equipment (name, manufacturer)设施和设备3.2.A.2 Adventitious Agents Safety Evaluation (name, dosage form, manufacturer)外源因子的安全性评价3.2.A.3 Excipients辅料3.2.R REGIONAL INFORMATION区域性信息3.3 Literature References参考文献Module 4: Nonclinical Study Reports4.1 Table of Contents of Module 44.2 Study Reports(见正文)4.2.1 Pharmacology4.2.1.1 Primary Pharmacodynamics4.2.1.2 Secondary Pharmacodynamics4.2.1.3 Safety Pharmacology4.2.1.4 Pharmacodynamic Drug Interactions4.2.2 Pharmacokinetics4.2.2.1 Analytical Methods and Validation Reports (if separate reports are available) 4.2.2.2 Absorption4.2.2.3 Distribution4.2.2.4 Metabolism4 2.2.5 Excretion4.2.2.6 Pharmacokinetic Drug Interactions (nonclinical)4.2.2.7 Other Pharmacokinetic Studies4.2.3 Toxicology4.2.3.1 Single-Dose Toxicity (in order by species, by route)4.2.3.2 Repeat-Dose Toxicity (in order by species, by route, by duration; including supportive toxicokinetics evaluations)4.2.3.3 Genotoxicity4.2.3.3.1 In vitro4.2.3.3.2 In vivo (including supportive toxicokinetics evaluations)4.2.3.4 Carcinogenicity (including supportive toxicokinetics evaluations)4.2.3.4.1 Long-term studies (in order by species; including range-finding studies that cannot appropriately be included under repeat-dose toxicity or pharmacokinetics)4.2.3.4.2 Short- or medium-term studies (including range-finding studies that cannot appropriately be included under repeat-dose toxicity or pharmacokinetics)4.2.3.4.3 Other studies4.2.3.5 Reproductive and Developmental Toxicity (including range-finding studies and supportive toxicokinetics evaluations) (If modified study designs are used, the following sub-headings should be modified accordingly.)4.2.3.5.1 Fertility and early embryonic development4.2.3.5.2 Embryo-fetal development4.2.3.5.3 Prenatal and postnatal development, including maternal function4.2.3.5.4 Studies in which the offspring (juvenile animals) are dosed and/or further evaluated.4.2.3.6 Local Tolerance4.2.3.7 Other Toxicity Studies (if available)4.2.3.7.1 Antigenicity4.2.3.7.2 Immunotoxicity4.2.3.7.3 Mechanistic studies (if not included elsewhere)4.2.3.7.4 Dependence4.2.3.7.5 Metabolites4.2.3.7.6 Impurities4.2.3.7.7 Other4.3 Literature ReferencesModule 5: Clinical Study Reports5.1 Table of Contents of Module 55.2 Tabular Listing of All Clinical Studies5.3 Clinical Study Reports5.3.1 Reports of Biopharmaceutic Studies5.3.1.1 Bioavailability (BA) Study Reports5.3.1.2 Comparative BA and Bioequivalence (BE) Study Reports5.3.1.3 In Vitro – In Vivo Correlation Study Reports5.3.1.4 Reports of Bioanalytical and Analytical Methods for Human Studies5.3.2 Reports of Studies Pertinent to Pharmacokinetics Using Human Biomaterials5.3.2.1 Plasma Protein Binding Study Reports5.3.2.2 Reports of Hepatic Metabolism and Drug Interaction Studies5.3.2.3 Reports of Studies Using Other Human Biomaterials5.3.3 Reports of Human Pharmacokinetic (PK) Studies5.3.3.1 Healthy Subject PK and Initial Tolerability Study Reports5.3.3.2 Patient PK and Initial Tolerability Study Reports5.3.3.3 Intrinsic Factor PK Study Reports5.3.3.4 Extrinsic Factor PK Study Reports5.3.3.5 Population PK Study Reports5.3.4 Reports of Human Pharmacodynamic (PD) Studies5.3.4.1 Healthy Subject PD and PK/PD Study Reports5.3.4.2 Patient PD and PK/PD Study Reports5.3.5 Reports of Efficacy and Safety Studies5.3.5.1 Study Reports of Controlled Clinical Studies Pertinent to the Claimed Indication5.3.5.2 Study Reports of Uncontrolled Clinical Studies5.3.5.3 Reports of Analyses of Data from More than One Study5.3.5.4 Other Study Reports5.3.6 Reports of Post-Marketing Experience5.3.7 Case Report Forms and Individual Patient Listings5.4 Literature ReferencesANNEX : Granularity Document参考ICH guidelines：M4E R1M4Q R1M4S R2。
化学与化工专业英语2-化学基础知识
Part 3 Chemical Calculation（化学计算 ）
3.1 化 学 术 语
atomic mass/weight ； molecular weight amount (of substance)； mole number of moles ； molar mass molar volume ； concentration molarity ； excess agent limiting agent ； reactant product ； yield
91
镤
Radium*
Ra
88
镭
Radon*
Rn
86
氡
Rhenium*
Re
75
铼
Rhodium*
4
铍
Bismuth*
Bi
83
铋
Boron*
B
5
硼
Bromine*
Br
35
溴
Cadmium*
Cd
48
镉
Calcium*
Ca
20
钙
Californium
Cf
98
锎
Carbon*
C
6
碳
Cerium
Ce
58
铈
Cesium*
Cs
55
铯
化 学 方 程 式
Part 2 Chemical Equations
2、反应条件
催化剂
04
高温、高压
03
3.1 Nitrogen reacts with hydrogen to form ammonia at high temperature and pressure with the presence of a catalyst.