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Drugs: From Discovery to Approval, 2nd Edition
Rick Ng0 ]" D. N/ e; J( K( u- q. a
November 2008, ©2009, Wiley-Blackwell

Table of Contents1 Q$ J+ L5 \9 {4 p8 q) Q( V/ d
PREFACE.6 _  r/ V1 K1 y4 ]7 J- @/ A
1 INTRODUCTION.2 B- V3 A. M, P) J* Z
1.1 Aim of This Book.0 J/ k: o( L, w% b
1.2 An Overview of the Drug Discovery and Development Process.( u. t$ r6 n* \" W
1.3 The Pharmaceutical Industry.
1.4 Economics of Drug Discovery and Development.  i/ X* x4 K' u3 [1 k+ a3 M
1.5 Trends in Drug Discovery and Development.
1.6 Case Study #1.
1.7 Summary of Important Points.
1.8 Review Questions.2 p. d* {% K+ S* t' R4 S
1.9 Brief Answers and Explanations.
1.10 Further Reading.
2 DRUG DISCOVERY: TARGETS AND RECEPTORS.8 s! U& ~5 t# i; F: A" m1 f
2.1 Drug Discovery Processes.
2.2 Medical Needs.
2.3 Target Identifi cation.. T( v* P1 |/ I3 o( h3 J
2.4 Target Validation.
2.5 Drug Interactions with Targets or Receptors.
2.6 Enzymes.
2.7 Receptors and Signal Transduction.
2.8 Assay Development.( o) F6 M& R; G% k- _
2.9 Case Study #2.7 Y7 \* _) P/ a$ b
2.10 Summary of Important Points.
2.11 Review Questions.) \9 F' }! `( p5 D# O& e2 b* q9 _
2.12 Brief Answers and Explanations.$ i1 o0 b. r% I# E4 ^( M9 |
2.13 Further Reading.
3 DRUG DISCOVERY: SMALL MOLECULE DRUGS.3 J9 i9 Q3 s. ^! x5 _- A' U
3.1 Introduction." R9 P. d0 v- ^7 I6 I' f
3.2 Irrational Approach.$ p' s! n% @4 G" g4 G$ ~5 j) A' F
3.3 Rational Approach.1 l/ X/ _  m( A" Y+ e' W* C5 V% k
3.4 Antisense Approach.
3.5 RNA Interference Approach.
3.6 Chiral Drugs., u  b) J0 s9 d" \7 Q  z
3.7 Closing Remarks.
3.8 Case Study #3.
3.9 Summary of Important Points.6 F! T4 B, M+ `6 M* |2 l8 k5 I& o
3.10 Review Questions.
3.11 Brief Answers and Explanations.
3.12 Further Reading.
4 DRUG DISCOVERY: LARGE MOLECULE DRUGS.9 H2 s% G/ F+ Z* L1 N3 E: u
4.1 Introduction.
4.2 Vaccines." b3 e1 u5 P* L( a
4.3 Antibodies.
4.4 Cytokines.1 t+ t2 p3 z% ^' y) ]8 u
4.5 Hormones.
4.6 Gene Therapy.. e+ k. j" z- r0 k. I- ~& [
4.7 Stem Cells and Cell Therapy.
4.8 Case Study #4.
4.9 Summary of Important Points.
4.10 Review Questions.. E* P3 r, I, e- k# Z1 t- [
4.11 Brief Answers and Explanations.7 E- O2 O* `2 ?+ ?$ m
4.12 Further Reading.
5 DRUG DEVELOPMENT AND PRECLINICAL STUDIES.
5.1 Introduction.( b) Q: g! k, {" z' ]# S( ^
5.2 Pharmacodynamics.
5.3 Pharmacokinetics.( J; E- p* c& x8 h$ E$ [
5.4 Toxicology.
5.5 Animal Tests, In Vitro Assays, and In Silico Methods.
5.6 Formulations and Delivery Systems.$ d0 Q$ E4 M3 j0 d
5.7 Nanotechnology.- O/ ?* i+ y! j5 _4 g0 c; k
5.8 Case Study #5.
5.9 Summary of Important Points.
5.10 Review Questions.
5.11 Brief Answers and Explanations.! J1 h, f3 G! H* h: H6 O
5.12 Further Reading.
6 CLINICAL TRIALS.2 V& j! O' C5 n6 q! ]" x( C
6.1 Defi nition of Clinical Trial.0 n8 \% }* ^# G# Q, g" L
6.2 Ethical Considerations.2 W2 V4 W4 J+ T
6.3 Clinical Trials.3 k0 t9 ~+ |3 a9 R1 X; j' J
6.4 Regulatory Requirements for Clinical Trials./ X0 c7 E' U  _5 k7 p6 Q. }- l+ f* O* x
6.5 Role of Regulatory Authorities.
6.6 Gene Therapy Clinical Trial.3 i8 w5 Y; _& @, _3 e+ {! d# N
6.7 Case Study #6.$ R- J3 @& I8 n% r" `
6.8 Summary of Important Points.
6.9 Review Questions.
6.10 Brief Answers and Explanations.; {( J8 n, q* C/ o1 o! q
6.11 Further Reading.
7 REGULATORY AUTHORITIES.
7.1 Role of Regulatory Authorities.; c! r3 U/ ^% X" Y, Y& U1 P
7.2 US Food and Drug Administration.
7.3 European Medicines Agency.
7.4 Japan’s Ministry of Health, Labor and Welfare.
7.5 China’s State Food and Drug Administration.* A$ v* y" j' g6 v
7.6 India’s Central Drugs Standard Control Organization.9 T+ E9 \/ W4 m* }* K4 s6 [0 W
7.7 Australia’s Therapeutics Goods Administration.7 y# ^% |, s$ f2 |" P8 j5 R8 Q
7.8 Canada’s Health Canada.: m( k# P- `) c
7.9 Other Regulatory Authorities.
7.10 Authorities Other than Drug Regulatory Agencies.
7.11 International Conference on Harmonization.
7.12 World Health Organization.
7.13 Pharmaceutical Inspection Cooperation Scheme.4 Y4 q' |. t$ n/ x$ x
7.14 Case Study #7.
7.15 Summary of Important Points.
7.16 Review Questions.
7.17 Brief Answers and Explanations.2 o1 `3 T9 S1 @# I/ o, v
7.18 Further Reading.
8 REGULATORY APPLICATIONS.
8.1 Introduction." }. w. b8 v$ x  s: s' a
8.2 Food and Drug Administration.' b+ x! L- g- c. a
8.3 European Union.' H% G& ~4 L4 F( B
8.4 Japan.
8.5 China./ o2 k" i) h3 c7 b
8.6 India.
8.7 Australia.
8.8 Canada.
8.9 Case Study #8.
8.10 Summary of Important Points.
8.11 Review Questions.# X. v9 \1 \- x; _0 {5 t9 A! Q. I
8.12 Brief Answers and Explanations.
8.13 Further Reading.
9 GOOD MANUFACTURING PRACTICE: REGULATORY REQUIREMENT., k# r! Q% ]2 Y
9.1 Introduction.
9.2 United States.; t; Z% D  o% C5 b: u5 o& N
9.3 Europe.
9.4 International Conference on Harmonization.3 X6 r# w  }8 q! E" Y
9.5 Core Elements of GMP.4 S* R6 W) _) b; D5 y, y9 D
9.6 Selected GMP Systems.! q, I) H9 A  O) C$ |; G, Q
9.7 The FDA’s New cGMP Initiative.
9.8 Case Study #9.  t( H# w+ ?& f
9.9 Summary of Important Points.
9.10 Review Questions.- m: b6 b- U0 ?! f8 h) o8 j3 X5 h! B$ j
9.11 Brief Answers and Explanations.6 i6 f# r# s) E& L6 A, `
9.12 Further Reading.
10 GOOD MANUFACTURING PRACTICE: DRUG MANUFACTURING.1 n+ o0 E9 e. J- Z/ C: @: X  r
10.1 Introduction.
10.2 GMP Manufacturing./ X; o! M' D* w  }, \
10.3 GMP Inspection.) @* f& H, S9 n4 F: P
10.4 Manufacture of Small Molecule APIs (Chemical Synthesis Methods).
10.5 Manufacture of Large Molecule APIs (Recombirant DNA Methods).  ]6 Y/ z4 C. w3 @9 R" D/ I) T4 G
10.6 Finished Dosage Forms.
11 FUTURE PERSPECTIVES.2 R7 o4 N7 P$ e. u& h" ^7 N+ {
11.1 Past Advances and Future Challenges., M* z# {( L1 M
11.2 Small Molecule Pharmaceutical Drugs.7 A  y! {3 ^% z- j4 J" Y& A" V
11.3 Large Molecule Biopharmaceutical Drugs.# E2 ?& |& S: F. W2 [6 {% c9 X
11.4 Traditional Medicine.# [6 x% H6 m1 |2 O( U
11.5 Individualized Medicine.* S8 X2 Z$ d% z7 w0 t: q4 S
APPENDIX 1 HISTORY OF DRUG DISCOVERY AND DEVELOPMENT.
A1.1 Early History of Medicine.* B' [. U7 L) m2 K; y5 w  o
A1.2 Drug Discovery and Development in the Middle Ages.+ f, t! b2 w, ?5 \# ^- J  E" y
A1.3 Foundation of Current Drug Discovery and Development.  n, z, ~6 ?/ x' o" k! r- F! ^2 I
A1.4 Beginnings of Modern Pharmaceutical Industry.
A1.5 Evolution of Drug Products.- t% j& J- w% [. N' L5 Z& I
A1.6 Further Reading.
APPENDIX 2 CELLS, NUCLEIC ACIDS, GENES, AND PROTEINS.% L% M1 O( Z# C1 z$ H6 ~: C
A2.1 Cells.* u1 I: @: {9 f
A2.2 Nucleic Acids.5 N. ?, h+ }6 a2 N# G" {+ O4 m
A2.3 Genes and Proteins.: ^) @& s: b' H( ]& J, H0 k
A2.4 Further Reading.
APPENDIX 3 SELECTED DRUGS AND THEIR MECHANISMS OF ACTION.9 C  ]8 p. }  P, Q2 O2 ~9 {$ l2 `& c
APPENDIX 4 A DHFR PLASMID VECTOR.
APPENDIX 5 VACCINE PRODUCTION METHODS.  K3 m7 s' u: a
APPENDIX 6 PHARMACOLOGY/ TOXICOLOGY.
REVIEW FORMAT.( P; l  l. Y# h7 y( t8 M
APPENDIX 7 EXAMPLES OF GENERAL BIOMARKERS.
APPENDIX 8 TOXICITY GRADING.
APPENDIX 9 HEALTH SYSTEMS IN SELECTED COUNTRIES.3 W3 |  m9 c1 j1 ?) _
ACRONYMS.
GLOSSARY.
INDEX.
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