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Drugs: From Discovery to Approval, 2nd Edition( I" ]$ ?! t* A. Y2 ]/ d# Z. V( I. `
Rick Ng
November 2008, ©2009, Wiley-Blackwell

Table of Contents
PREFACE.5 o2 F- [" @! l) q
1 INTRODUCTION.
1.1 Aim of This Book.9 F! }0 W! z, {1 n8 y6 y
1.2 An Overview of the Drug Discovery and Development Process.
1.3 The Pharmaceutical Industry.7 v  L1 h5 ^$ ^' Q( [
1.4 Economics of Drug Discovery and Development.2 M+ b6 N2 x( L
1.5 Trends in Drug Discovery and Development.
1.6 Case Study #1./ s- Z0 }7 f6 A2 O
1.7 Summary of Important Points.  F5 N- u6 D; G4 ]$ S2 I: i; l
1.8 Review Questions.
1.9 Brief Answers and Explanations.
1.10 Further Reading.8 c0 g5 @% F2 C1 j" o
2 DRUG DISCOVERY: TARGETS AND RECEPTORS.
2.1 Drug Discovery Processes.
2.2 Medical Needs.: Y. H4 s' y! }7 E' J1 O( V9 _. m: ~
2.3 Target Identifi cation.
2.4 Target Validation.) m+ g- \" ~8 F5 q: ^/ n" l$ u) @* o
2.5 Drug Interactions with Targets or Receptors.# Q3 c9 W9 F9 P5 r) f* T
2.6 Enzymes.) E8 p" z1 U2 {! o6 p" s3 H: `
2.7 Receptors and Signal Transduction.1 E1 o2 G! O$ k3 s
2.8 Assay Development.& C# J# n6 \8 G
2.9 Case Study #2.
2.10 Summary of Important Points.$ R) j" s; e( j& w6 m, V$ {2 ]6 B- a
2.11 Review Questions.0 m* n* }( R8 I$ N
2.12 Brief Answers and Explanations.
2.13 Further Reading.
3 DRUG DISCOVERY: SMALL MOLECULE DRUGS.# J( J$ K5 I9 D
3.1 Introduction.7 O0 [# d; L" H  w! a8 g7 d
3.2 Irrational Approach.
3.3 Rational Approach.
3.4 Antisense Approach.: r6 i5 G9 p& |) Y: q
3.5 RNA Interference Approach.- H3 t7 n6 C2 b# }5 @4 {
3.6 Chiral Drugs.
3.7 Closing Remarks.2 j5 g3 L& z/ W
3.8 Case Study #3.+ f! s$ H6 u& J" F3 G
3.9 Summary of Important Points.; [3 g4 D; k# c! [
3.10 Review Questions.* u/ D9 y2 m1 I/ M
3.11 Brief Answers and Explanations.
3.12 Further Reading.
4 DRUG DISCOVERY: LARGE MOLECULE DRUGS.
4.1 Introduction.
4.2 Vaccines.+ f$ `: [4 b8 P; V
4.3 Antibodies.
4.4 Cytokines.
4.5 Hormones.+ y. }/ L! y5 u  h" s
4.6 Gene Therapy.
4.7 Stem Cells and Cell Therapy.
4.8 Case Study #4.) L  Z: `( z. J+ q
4.9 Summary of Important Points., e$ u+ f6 V9 u! q
4.10 Review Questions.7 L) X# ~% Q0 g) e6 z9 `% ~
4.11 Brief Answers and Explanations.
4.12 Further Reading.
5 DRUG DEVELOPMENT AND PRECLINICAL STUDIES.
5.1 Introduction.) n) z; U' r6 r$ z0 ?7 M. T
5.2 Pharmacodynamics.
5.3 Pharmacokinetics.
5.4 Toxicology.
5.5 Animal Tests, In Vitro Assays, and In Silico Methods.
5.6 Formulations and Delivery Systems.0 K) C, G' o& {, x1 z; G
5.7 Nanotechnology.* O  \2 w* g8 A! q
5.8 Case Study #5.- ^4 M+ y& `" p' c$ P4 u3 d/ L, w2 a0 b' A
5.9 Summary of Important Points., a, s& U, I( g! ]# J2 N- c4 W$ D# f! B
5.10 Review Questions.4 ]$ Z! @& h% k" Q3 D$ ]+ x
5.11 Brief Answers and Explanations.  X9 u' w5 H9 W0 B
5.12 Further Reading.9 e8 D7 q3 q  R: V$ h3 i' c
6 CLINICAL TRIALS.+ L$ W$ p5 s* Q$ B- r
6.1 Defi nition of Clinical Trial.( K6 Y) ^1 H  u* W, W
6.2 Ethical Considerations.
6.3 Clinical Trials.2 P! D! I7 O% b* L) w$ j& R! n/ u
6.4 Regulatory Requirements for Clinical Trials.. d2 P3 r0 b9 a1 ^7 x3 q
6.5 Role of Regulatory Authorities.& P0 j6 B  W  `" l0 `
6.6 Gene Therapy Clinical Trial.* p( z/ [2 Y! u9 |: y
6.7 Case Study #6., J) Z4 n8 @8 D4 f1 @, b
6.8 Summary of Important Points.
6.9 Review Questions.
6.10 Brief Answers and Explanations.
6.11 Further Reading.8 a- s9 ~1 ]$ |2 w
7 REGULATORY AUTHORITIES.
7.1 Role of Regulatory Authorities.
7.2 US Food and Drug Administration.2 o1 E8 Y1 U& k- J4 a
7.3 European Medicines Agency.
7.4 Japan’s Ministry of Health, Labor and Welfare.
7.5 China’s State Food and Drug Administration.* h' ~5 B0 f4 e! b5 `2 g9 n
7.6 India’s Central Drugs Standard Control Organization.& s& x& Y; ~0 Z- `+ Z7 {0 w, O
7.7 Australia’s Therapeutics Goods Administration.
7.8 Canada’s Health Canada.
7.9 Other Regulatory Authorities.
7.10 Authorities Other than Drug Regulatory Agencies.
7.11 International Conference on Harmonization.: I( v7 t: n- C0 N, ~
7.12 World Health Organization.1 s5 h$ b( O0 T7 w- @% t  @
7.13 Pharmaceutical Inspection Cooperation Scheme.% H" @1 Y" E% t% B7 F0 i9 B3 T' W/ e
7.14 Case Study #7.- W7 n' i# A* R! c! F1 ?" {1 p
7.15 Summary of Important Points.
7.16 Review Questions.
7.17 Brief Answers and Explanations.
7.18 Further Reading.: u8 y/ H) A* B7 O1 s% [7 c) e/ i
8 REGULATORY APPLICATIONS.
8.1 Introduction.
8.2 Food and Drug Administration.; H7 `* ?  s; q  N( e$ `% t: W2 q: ]* P
8.3 European Union./ x: z0 V* I$ I  l- v, J9 g
8.4 Japan.
8.5 China.
8.6 India.# V7 n, U: B+ l* A4 d
8.7 Australia.+ C& f! h  O% ]
8.8 Canada.
8.9 Case Study #8.
8.10 Summary of Important Points.1 U% p0 a9 y3 D0 R8 y, B+ ?/ ]
8.11 Review Questions.
8.12 Brief Answers and Explanations.
8.13 Further Reading.% h$ n/ V1 b! L7 W1 N
9 GOOD MANUFACTURING PRACTICE: REGULATORY REQUIREMENT.
9.1 Introduction.
9.2 United States.$ V# O# D3 G6 o
9.3 Europe.* F. s3 s: j- g, W. c- g$ O
9.4 International Conference on Harmonization.
9.5 Core Elements of GMP.6 Z4 U2 d/ V: A% C
9.6 Selected GMP Systems.
9.7 The FDA’s New cGMP Initiative.
9.8 Case Study #9.
9.9 Summary of Important Points.
9.10 Review Questions.
9.11 Brief Answers and Explanations.# s1 R5 H0 k  }! w/ g# r2 ?8 z
9.12 Further Reading.( M$ ~# L) f/ B& q
10 GOOD MANUFACTURING PRACTICE: DRUG MANUFACTURING.+ Q) j2 R" j8 |7 ~
10.1 Introduction." b/ g+ [) n  z" ]. j. N
10.2 GMP Manufacturing.
10.3 GMP Inspection.* I9 ~, U4 b. h0 Y) A2 V3 f! `# }( O
10.4 Manufacture of Small Molecule APIs (Chemical Synthesis Methods).) W% k/ F( N" v: Z: |" o; y
10.5 Manufacture of Large Molecule APIs (Recombirant DNA Methods).) ?) [4 ^' a& F
10.6 Finished Dosage Forms.
11 FUTURE PERSPECTIVES.9 K% a6 \6 r& }/ f% k$ a
11.1 Past Advances and Future Challenges.. G% f5 ^% I' k1 b
11.2 Small Molecule Pharmaceutical Drugs.: F6 J8 x6 o- _
11.3 Large Molecule Biopharmaceutical Drugs.
11.4 Traditional Medicine.1 v. o  c% w6 Z3 Y4 T
11.5 Individualized Medicine.; b8 q& V9 {$ J1 Q/ P+ u3 B
APPENDIX 1 HISTORY OF DRUG DISCOVERY AND DEVELOPMENT.+ {# c! v% I* x- c& G
A1.1 Early History of Medicine.0 ~& w* _* g+ @$ O& x. ^. x
A1.2 Drug Discovery and Development in the Middle Ages.
A1.3 Foundation of Current Drug Discovery and Development.
A1.4 Beginnings of Modern Pharmaceutical Industry.
A1.5 Evolution of Drug Products.# p4 G6 c. ]) N: ]  [$ f8 Y# t
A1.6 Further Reading.
APPENDIX 2 CELLS, NUCLEIC ACIDS, GENES, AND PROTEINS.
A2.1 Cells.
A2.2 Nucleic Acids.* E- a& W2 j1 h
A2.3 Genes and Proteins.& `/ Z5 {. V9 Z- d$ A7 O
A2.4 Further Reading.
APPENDIX 3 SELECTED DRUGS AND THEIR MECHANISMS OF ACTION.+ n3 P0 R' \. E2 w9 M! k4 m3 ^9 \! r
APPENDIX 4 A DHFR PLASMID VECTOR.: {/ I/ @) c  c, S$ W( l+ K8 v
APPENDIX 5 VACCINE PRODUCTION METHODS./ l! d7 m1 }) C% N, z/ {1 x5 P% h
APPENDIX 6 PHARMACOLOGY/ TOXICOLOGY.) m- o* ^* \1 }, K$ Z/ f# }
REVIEW FORMAT.; s4 {- l2 q3 I6 R- M6 a- F( W
APPENDIX 7 EXAMPLES OF GENERAL BIOMARKERS.
APPENDIX 8 TOXICITY GRADING.- k( L. G, _" E. ^8 R
APPENDIX 9 HEALTH SYSTEMS IN SELECTED COUNTRIES.. K0 X' [6 |/ F, P
ACRONYMS.
GLOSSARY.  x4 l0 D. W7 A2 u7 _9 e$ P
INDEX.
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