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Drugs: From Discovery to Approval, 2nd Edition3 C6 g7 W8 [& U6 H
Rick Ng
November 2008, ©2009, Wiley-Blackwell# x! o. Q4 }. ^, e3 e: p* W7 w

Table of Contents
PREFACE.
1 INTRODUCTION.
1.1 Aim of This Book.
1.2 An Overview of the Drug Discovery and Development Process.' Y" q' ]- Q; ~/ O, S
1.3 The Pharmaceutical Industry.
1.4 Economics of Drug Discovery and Development.
1.5 Trends in Drug Discovery and Development.
1.6 Case Study #1.0 Y# q; v) G+ w$ s5 H
1.7 Summary of Important Points.  l% T+ @  W7 Y2 o2 y
1.8 Review Questions.3 P  Q7 O+ B6 Z& E( l
1.9 Brief Answers and Explanations.& T- z" R: X* M- ~- _) e$ x) l6 t
1.10 Further Reading.
2 DRUG DISCOVERY: TARGETS AND RECEPTORS.7 w: V& g2 S0 ]; M9 {8 ^
2.1 Drug Discovery Processes.0 o0 D5 x7 F$ n$ j0 G  @  G$ k0 Q
2.2 Medical Needs., c! v7 v/ C6 V: Z
2.3 Target Identifi cation.
2.4 Target Validation.
2.5 Drug Interactions with Targets or Receptors.
2.6 Enzymes., K  h3 r* t3 m
2.7 Receptors and Signal Transduction.7 w  C" \: ?7 D+ C
2.8 Assay Development.) {' m3 t; U1 S% j8 N
2.9 Case Study #2.1 U+ w% ~- x9 b0 {1 E0 N
2.10 Summary of Important Points.& |5 ^, J; h: {! r: M  s
2.11 Review Questions.
2.12 Brief Answers and Explanations.  L9 Y: o9 K& `; P+ l0 e6 `
2.13 Further Reading.
3 DRUG DISCOVERY: SMALL MOLECULE DRUGS.
3.1 Introduction.* N: c) g* g' D) O- E7 ~7 B
3.2 Irrational Approach.' Z  s/ X! Z% ~
3.3 Rational Approach.
3.4 Antisense Approach.7 Y0 `* K( p, K9 k$ r% O
3.5 RNA Interference Approach.
3.6 Chiral Drugs.
3.7 Closing Remarks.
3.8 Case Study #3.! ^! @. _; N1 G9 h9 O4 c3 ~" T
3.9 Summary of Important Points.
3.10 Review Questions.
3.11 Brief Answers and Explanations.: T$ L/ _7 d9 U9 }! N; T
3.12 Further Reading.1 Z$ W& b/ {( c4 M. D  w: v3 ~1 T- X6 e
4 DRUG DISCOVERY: LARGE MOLECULE DRUGS.
4.1 Introduction.& F% U3 i) P4 D
4.2 Vaccines.( i, h; P$ q  m/ G0 M3 Q! e
4.3 Antibodies.7 l8 [2 f, u( A/ V8 z) x0 H
4.4 Cytokines.
4.5 Hormones.
4.6 Gene Therapy.+ _9 T- `5 D, W) q( \1 X
4.7 Stem Cells and Cell Therapy.
4.8 Case Study #4.
4.9 Summary of Important Points.  N9 c( {! B5 Z" \; {$ v* _( l
4.10 Review Questions.
4.11 Brief Answers and Explanations.7 X- W2 ~" G6 |# H
4.12 Further Reading.7 o8 f+ n- Y  K* \( w! O
5 DRUG DEVELOPMENT AND PRECLINICAL STUDIES.0 M& \1 H' u, T; {; P! D1 Z7 M
5.1 Introduction.
5.2 Pharmacodynamics.
5.3 Pharmacokinetics.
5.4 Toxicology.0 ?1 H  f# ], N6 H$ G
5.5 Animal Tests, In Vitro Assays, and In Silico Methods.
5.6 Formulations and Delivery Systems.
5.7 Nanotechnology.5 m2 ^5 s" T3 G3 E* Q2 T; c
5.8 Case Study #5.1 H) z: E4 h  w3 y6 J
5.9 Summary of Important Points.
5.10 Review Questions.
5.11 Brief Answers and Explanations.
5.12 Further Reading.1 A/ c0 b; [6 f4 g( ~5 \0 I( G2 j
6 CLINICAL TRIALS.( I% l& \; [4 ?# f8 x9 f4 s
6.1 Defi nition of Clinical Trial.+ D9 J2 `" m* l$ U0 \
6.2 Ethical Considerations.
6.3 Clinical Trials.
6.4 Regulatory Requirements for Clinical Trials.
6.5 Role of Regulatory Authorities.& o! i1 H$ o" \
6.6 Gene Therapy Clinical Trial.
6.7 Case Study #6.# A( Y$ X" X3 \  j- [  X
6.8 Summary of Important Points.
6.9 Review Questions." S+ {/ v% L7 s
6.10 Brief Answers and Explanations., f$ F6 C2 e& n' I6 Q
6.11 Further Reading." D5 R: f" `& W; C
7 REGULATORY AUTHORITIES.
7.1 Role of Regulatory Authorities.( r) s: C4 y" C$ s3 F) h
7.2 US Food and Drug Administration.
7.3 European Medicines Agency.' e. p* }6 J" A" z9 p& F
7.4 Japan’s Ministry of Health, Labor and Welfare.* P/ M5 H" t4 n+ `6 R, E2 p
7.5 China’s State Food and Drug Administration.
7.6 India’s Central Drugs Standard Control Organization.& O8 k: B$ Z3 L8 w1 C9 B2 u* _
7.7 Australia’s Therapeutics Goods Administration.9 |7 e9 I9 K! G; g1 f" H
7.8 Canada’s Health Canada.: M& K" \- I7 X2 M) x; ]8 d$ ^
7.9 Other Regulatory Authorities.0 z1 X9 }5 `! h1 Y/ M4 ]4 V
7.10 Authorities Other than Drug Regulatory Agencies.
7.11 International Conference on Harmonization.3 T, u6 y7 I* W- M
7.12 World Health Organization.8 T  z& T& Y8 Q+ m6 K/ I
7.13 Pharmaceutical Inspection Cooperation Scheme.
7.14 Case Study #7.
7.15 Summary of Important Points.
7.16 Review Questions.1 S1 d4 o* N/ A9 C2 m" M. `
7.17 Brief Answers and Explanations.8 p6 \4 k9 }" ?7 v1 h! F
7.18 Further Reading.
8 REGULATORY APPLICATIONS.
8.1 Introduction.
8.2 Food and Drug Administration.
8.3 European Union.- N. x, Y  m% M. O# G5 m
8.4 Japan.
8.5 China.0 K- G% o4 e( j
8.6 India.
8.7 Australia.! c: e4 B. Q* E
8.8 Canada.4 K' y- r2 ~! V
8.9 Case Study #8.) L- f, A' U1 g2 v* Y
8.10 Summary of Important Points./ R7 q4 D! A! b
8.11 Review Questions.  R9 k' U" f6 r1 f. q
8.12 Brief Answers and Explanations.- f0 s1 x6 \  `4 T$ r4 l! a
8.13 Further Reading.: ~- j8 i/ q' {
9 GOOD MANUFACTURING PRACTICE: REGULATORY REQUIREMENT.
9.1 Introduction.
9.2 United States.% G5 P, n5 B  l0 s! j* N( M
9.3 Europe.1 w1 k$ y$ s. Q$ V
9.4 International Conference on Harmonization.  \* e0 N; A; x, |8 K: R
9.5 Core Elements of GMP.0 i  r0 @; B0 P% c# R$ v" U
9.6 Selected GMP Systems.
9.7 The FDA’s New cGMP Initiative.
9.8 Case Study #9.7 K: h( T& }7 }8 \
9.9 Summary of Important Points.
9.10 Review Questions.
9.11 Brief Answers and Explanations.
9.12 Further Reading.. X, E* @" V9 V6 m8 U( A
10 GOOD MANUFACTURING PRACTICE: DRUG MANUFACTURING.
10.1 Introduction.
10.2 GMP Manufacturing.% o- z2 ^" V9 ^5 O7 p# |" R" g
10.3 GMP Inspection.
10.4 Manufacture of Small Molecule APIs (Chemical Synthesis Methods).* ^' V: v' T* T+ v4 o) H( k
10.5 Manufacture of Large Molecule APIs (Recombirant DNA Methods).
10.6 Finished Dosage Forms.
11 FUTURE PERSPECTIVES.* P) x9 e. ^- m$ i0 q$ N
11.1 Past Advances and Future Challenges.
11.2 Small Molecule Pharmaceutical Drugs.
11.3 Large Molecule Biopharmaceutical Drugs.
11.4 Traditional Medicine.; K  H' T1 Q/ ~0 D
11.5 Individualized Medicine.2 [' m. s4 ^3 b( _. E0 l
APPENDIX 1 HISTORY OF DRUG DISCOVERY AND DEVELOPMENT.: k# f( w6 u# P; y# N- z& f
A1.1 Early History of Medicine.
A1.2 Drug Discovery and Development in the Middle Ages.. d5 Z4 L% B; z. c% H; O# U/ ~
A1.3 Foundation of Current Drug Discovery and Development.% d* \% |; @0 r* K
A1.4 Beginnings of Modern Pharmaceutical Industry.( m+ `7 ]- W+ r, ^3 s
A1.5 Evolution of Drug Products.9 p% ]& p4 _6 @& k7 C+ e3 b
A1.6 Further Reading.
APPENDIX 2 CELLS, NUCLEIC ACIDS, GENES, AND PROTEINS.
A2.1 Cells.' ~8 b# Z  Z- r( }  ~+ V
A2.2 Nucleic Acids.( p$ G! n2 |/ p" y  P  ^
A2.3 Genes and Proteins.0 ]  K$ p: @5 D* F3 u1 u* z
A2.4 Further Reading.
APPENDIX 3 SELECTED DRUGS AND THEIR MECHANISMS OF ACTION.
APPENDIX 4 A DHFR PLASMID VECTOR.
APPENDIX 5 VACCINE PRODUCTION METHODS.& H' e' X. O1 o/ n% [2 V
APPENDIX 6 PHARMACOLOGY/ TOXICOLOGY.
REVIEW FORMAT.# H0 v& k- o- M* p$ z
APPENDIX 7 EXAMPLES OF GENERAL BIOMARKERS.
APPENDIX 8 TOXICITY GRADING.: ?) z* G: i  b
APPENDIX 9 HEALTH SYSTEMS IN SELECTED COUNTRIES." v1 X; Q. Q! O. k0 S
ACRONYMS.
GLOSSARY.
INDEX." D$ r$ {# q2 G* I- q" {
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