PDF电子书：Drugs: From Discovery to Approval, 2nd - 经典PDF电子书下载区干细胞之家



免疫细胞治疗专区	欢迎关注干细胞微信公众号

12 3 4 5 6 7 8 9 10 ... 24 下一页

返回列表

查看: 868825\|回复: 237	go [干细胞与细胞生物学类] PDF电子书：Drugs: From Discovery to Approval, 2nd [复制链接]

dahui

高级会员

Rank: 4

积分: 1343
威望: 1343
包包: 387

金话筒优秀会员热心会员小小研究员积极份子帅哥研究员

楼主

发表于 2014-12-3 08:32 |只看该作者 |倒序浏览 |打印

本帖最后由细胞海洋于 2014-12-4 09:22 编辑

+ u. a. ^& s2 m; t( O5 ~  `8 l
Drugs: From Discovery to Approval, 2nd Edition. H8 b2 d7 e$ s! I" ]* F
Rick Ng
November 2008, ©2009, Wiley-Blackwell
9 ]0 U# R, q3 `# p. t: o
Table of Contents
PREFACE.
1 INTRODUCTION.& V- ]; s, C& G4 \
1.1 Aim of This Book.) Z2 G! r" \1 ]5 y; B8 k) ~
1.2 An Overview of the Drug Discovery and Development Process.! B& h; ?, L3 O7 T$ S: f: V
1.3 The Pharmaceutical Industry.& j8 q& l5 `1 Q- H
1.4 Economics of Drug Discovery and Development.
1.5 Trends in Drug Discovery and Development.
1.6 Case Study #1.- f5 m& C. Z7 g+ I$ a
1.7 Summary of Important Points.
1.8 Review Questions.* G, \# @6 v/ W2 K
1.9 Brief Answers and Explanations.
1.10 Further Reading.
2 DRUG DISCOVERY: TARGETS AND RECEPTORS.1 G% ~- ?# d) H. H1 ^% Q  v- p
2.1 Drug Discovery Processes.
2.2 Medical Needs.6 {* [: P; v; G' C9 d" k8 q
2.3 Target Identifi cation.
2.4 Target Validation.; _; }3 d; S% F$ e7 f% f. b
2.5 Drug Interactions with Targets or Receptors.5 \! ~5 a$ |+ ~1 ^9 V+ k' r
2.6 Enzymes.
2.7 Receptors and Signal Transduction.4 W! z- O! A' Z* {* A8 z
2.8 Assay Development.. A6 b7 }2 z  o
2.9 Case Study #2.
2.10 Summary of Important Points.
2.11 Review Questions.
2.12 Brief Answers and Explanations./ a4 ]  [! n+ v9 ]
2.13 Further Reading.0 b% ~# c  x5 W& w
3 DRUG DISCOVERY: SMALL MOLECULE DRUGS.
3.1 Introduction.8 h1 b! D# P# b6 O) T
3.2 Irrational Approach.
3.3 Rational Approach.
3.4 Antisense Approach.3 o! ~+ c5 i; P$ e+ R+ ]; c
3.5 RNA Interference Approach.2 j& A5 L! ~- I9 r$ I9 h+ Y
3.6 Chiral Drugs.5 o5 j) `) s1 h/ ^: {7 K1 Z: {% s
3.7 Closing Remarks.
3.8 Case Study #3.
3.9 Summary of Important Points.2 K! e' E! _$ @9 g7 @
3.10 Review Questions.
3.11 Brief Answers and Explanations.: k- l, T1 F0 o, ~
3.12 Further Reading.# F8 `) [4 n& E+ }2 q
4 DRUG DISCOVERY: LARGE MOLECULE DRUGS.
4.1 Introduction.
4.2 Vaccines.
4.3 Antibodies.& ?3 f) j' W6 i" B& w
4.4 Cytokines./ s/ |4 y1 J7 F- H, X2 r/ @0 Z
4.5 Hormones.8 R0 H, y: ~% C
4.6 Gene Therapy.& o! e$ g: S- s2 J7 p
4.7 Stem Cells and Cell Therapy.) G, _7 Q: W! h0 Y) d
4.8 Case Study #4.' M8 r" U- D3 c  M( X5 O  y
4.9 Summary of Important Points.0 w+ a! i# F% t+ L7 g
4.10 Review Questions.1 {8 `2 T' d: `6 Z
4.11 Brief Answers and Explanations., _/ g/ N" y1 Z
4.12 Further Reading.! x3 F! W# I' A6 |) |; o
5 DRUG DEVELOPMENT AND PRECLINICAL STUDIES.
5.1 Introduction.
5.2 Pharmacodynamics.
5.3 Pharmacokinetics.
5.4 Toxicology.
5.5 Animal Tests, In Vitro Assays, and In Silico Methods., b5 u- a$ b! B/ [2 f' R
5.6 Formulations and Delivery Systems.
5.7 Nanotechnology.
5.8 Case Study #5.
5.9 Summary of Important Points.+ d9 g' R2 a. }5 [; D3 R2 C
5.10 Review Questions.
5.11 Brief Answers and Explanations.! W/ {* U6 V" u
5.12 Further Reading.
6 CLINICAL TRIALS.
6.1 Defi nition of Clinical Trial.4 X1 k- Z& N1 }7 [. Z
6.2 Ethical Considerations.
6.3 Clinical Trials.# ?+ A+ o, Q4 X
6.4 Regulatory Requirements for Clinical Trials.
6.5 Role of Regulatory Authorities.. Q1 T7 B- \7 Q
6.6 Gene Therapy Clinical Trial.
6.7 Case Study #6.8 `+ d2 y5 N5 z8 |" n) ^
6.8 Summary of Important Points.7 a  e" v) @9 c
6.9 Review Questions.
6.10 Brief Answers and Explanations.2 [$ e7 o# y, A, e8 [2 S
6.11 Further Reading./ h) d* K* S5 u& i; o3 a$ ]! c
7 REGULATORY AUTHORITIES.. s  S5 G4 @  N* ]( J, ?* @; G
7.1 Role of Regulatory Authorities.9 m, k! i4 Y( @& G- ^7 B# z3 V
7.2 US Food and Drug Administration.4 M6 @% ~+ l) y$ i- x% D
7.3 European Medicines Agency.
7.4 Japan’s Ministry of Health, Labor and Welfare.5 L% v: z: l: d4 Q
7.5 China’s State Food and Drug Administration." S/ X; u) L- m+ B) k# p% {
7.6 India’s Central Drugs Standard Control Organization.
7.7 Australia’s Therapeutics Goods Administration.
7.8 Canada’s Health Canada.- L9 y# [  O( I6 {& L
7.9 Other Regulatory Authorities.& h# z; S# g9 c! E: x
7.10 Authorities Other than Drug Regulatory Agencies.
7.11 International Conference on Harmonization.& K6 g$ U9 A8 `) `
7.12 World Health Organization.
7.13 Pharmaceutical Inspection Cooperation Scheme.
7.14 Case Study #7.
7.15 Summary of Important Points.( E5 q" `' }; p- Z! w; w
7.16 Review Questions.
7.17 Brief Answers and Explanations.8 `5 X& m2 r  u. n5 J; ]3 ?
7.18 Further Reading.
8 REGULATORY APPLICATIONS.
8.1 Introduction.
8.2 Food and Drug Administration.* a+ u; Y$ H% W& S+ ^2 H) @
8.3 European Union.
8.4 Japan./ S) S6 M. H) H
8.5 China.
8.6 India.
8.7 Australia.
8.8 Canada., ~8 X" J, Z9 V8 i5 `5 N! ?, w% {& H
8.9 Case Study #8.2 ~; \/ o3 D4 t+ d3 i0 W/ q
8.10 Summary of Important Points.- \& K3 T, ?3 w% V0 }8 r7 B- B
8.11 Review Questions.
8.12 Brief Answers and Explanations.
8.13 Further Reading.
9 GOOD MANUFACTURING PRACTICE: REGULATORY REQUIREMENT.
9.1 Introduction.
9.2 United States.4 `1 S) ^$ V, S6 N1 ^; t/ Z; t
9.3 Europe.7 M# q) w; s6 n  I
9.4 International Conference on Harmonization.0 U' m) p7 x+ P0 [
9.5 Core Elements of GMP.! G# K' n2 E- w! U. l# P
9.6 Selected GMP Systems.! u) a2 t) z6 m7 h  |
9.7 The FDA’s New cGMP Initiative.5 b0 Z2 y) {0 J8 I& G% P
9.8 Case Study #9., L. G; z: h7 D5 t
9.9 Summary of Important Points.8 P, {) n% y& l, ]# v! T5 ^
9.10 Review Questions.
9.11 Brief Answers and Explanations.
9.12 Further Reading.
10 GOOD MANUFACTURING PRACTICE: DRUG MANUFACTURING./ v) [" v$ e' w+ ?/ g/ @: V, I
10.1 Introduction.
10.2 GMP Manufacturing.  ~! d* ]2 A" u% S
10.3 GMP Inspection.7 K3 u, o$ W+ N* R
10.4 Manufacture of Small Molecule APIs (Chemical Synthesis Methods).
10.5 Manufacture of Large Molecule APIs (Recombirant DNA Methods).) U/ Q  q- A, @. b
10.6 Finished Dosage Forms.0 E) b) z6 T+ D! z, ~& a% y+ ^. V
11 FUTURE PERSPECTIVES.9 P3 `1 J. |; L4 I/ @7 P
11.1 Past Advances and Future Challenges.
11.2 Small Molecule Pharmaceutical Drugs.
11.3 Large Molecule Biopharmaceutical Drugs.( W% @5 l9 {8 j8 ?9 f
11.4 Traditional Medicine.$ J' _; s) D6 H5 B8 \! [! B
11.5 Individualized Medicine.
APPENDIX 1 HISTORY OF DRUG DISCOVERY AND DEVELOPMENT.: C" q3 j6 a2 r
A1.1 Early History of Medicine.
A1.2 Drug Discovery and Development in the Middle Ages.3 ?9 X( k6 \  j8 P
A1.3 Foundation of Current Drug Discovery and Development.3 f! c- Z$ Z; u0 X8 e5 g4 y
A1.4 Beginnings of Modern Pharmaceutical Industry.! F2 G# o9 @& y( M! w
A1.5 Evolution of Drug Products.
A1.6 Further Reading.* B+ ?! e6 O5 w, o1 Z
APPENDIX 2 CELLS, NUCLEIC ACIDS, GENES, AND PROTEINS.
A2.1 Cells.
A2.2 Nucleic Acids.4 v9 N. S, x5 b, z  l* L3 S% Q  z. u
A2.3 Genes and Proteins.2 y$ B) o: h8 E1 t
A2.4 Further Reading.( ?, s( l3 t' o; E; n, Y2 D6 \
APPENDIX 3 SELECTED DRUGS AND THEIR MECHANISMS OF ACTION.8 u) l7 a: d7 O' V# M7 V4 v  M
APPENDIX 4 A DHFR PLASMID VECTOR." ^7 p+ i3 J7 e; I
APPENDIX 5 VACCINE PRODUCTION METHODS.2 N3 q& f7 y9 ^! B, M2 c- w/ `
APPENDIX 6 PHARMACOLOGY/ TOXICOLOGY.9 ?1 f2 V" Y( E+ x5 ]; A
REVIEW FORMAT.
APPENDIX 7 EXAMPLES OF GENERAL BIOMARKERS.
APPENDIX 8 TOXICITY GRADING.
APPENDIX 9 HEALTH SYSTEMS IN SELECTED COUNTRIES., \, \  E8 D% K$ r3 h
ACRONYMS.% i5 C, f6 l$ {' o9 i
GLOSSARY.
INDEX.
[hide][/hide]

附件: 你需要登录才可以下载或查看附件。没有帐号？注册