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本帖最后由 细胞海洋 于 2014-12-4 09:22 编辑 ! V/ L% l) }! o1 ?, a% V* m
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Drugs: From Discovery to Approval, 2nd Edition' P6 T) `+ |2 w+ P
Rick Ng0 L! O' P5 n( U4 Y, R6 I9 p
November 2008, ©2009, Wiley-Blackwell
5 L) K- U- R& W" ~: I! F0 v1 W+ c
; {0 \, |' L3 `& ^8 WTable of Contents1 I3 H5 y1 r1 L, U1 ~
PREFACE.
" c( P# g2 @" x. F4 w" l) w, r# f1 INTRODUCTION.
1 u" m' a4 {: ]$ n {1.1 Aim of This Book.4 I2 U# J+ @0 |* p2 k: p. v
1.2 An Overview of the Drug Discovery and Development Process.
2 p ^1 q4 l3 O" G1.3 The Pharmaceutical Industry.4 l% S( v1 u+ O0 I, k+ |
1.4 Economics of Drug Discovery and Development.
' R% w7 |, l1 r7 ]+ J( Z8 B, b1.5 Trends in Drug Discovery and Development.
: J0 A# p4 c8 B' N- \3 M* \6 Z& P1.6 Case Study #1.& K0 X. t3 {% u7 P
1.7 Summary of Important Points.4 J$ V! w2 l; v
1.8 Review Questions.$ s- h' n6 w a [' V$ u2 \
1.9 Brief Answers and Explanations. z% a4 C& M$ e5 p& e& s D
1.10 Further Reading. I0 r& y) N7 c8 T, X
2 DRUG DISCOVERY: TARGETS AND RECEPTORS.
* v9 {0 y5 V4 u' ]7 f; z# T+ B2.1 Drug Discovery Processes.
* W" A8 v3 S0 L! _+ p5 f6 U1 y2.2 Medical Needs.
& P" R7 E2 F+ C" M3 E& |# z* s4 o2.3 Target Identifi cation.
& w- K- f: f( D6 t2.4 Target Validation.; M: h Y$ l% D( L1 @- W; z
2.5 Drug Interactions with Targets or Receptors.
2 n. Q t$ a( T+ F, o, e8 G) V- P2.6 Enzymes.# X+ [& J8 G1 O4 @
2.7 Receptors and Signal Transduction.4 D% g+ c' @; M5 w o- B
2.8 Assay Development.# Q8 u% | }/ v1 z
2.9 Case Study #2./ o: a3 o( a. z; w# r. ]
2.10 Summary of Important Points.
8 P" r8 K( A5 r* R2.11 Review Questions.7 D0 l; e/ h! }& [$ [9 K
2.12 Brief Answers and Explanations.& J, t' i3 D4 z/ w7 K
2.13 Further Reading.$ l; p6 ~5 m6 n# T; A
3 DRUG DISCOVERY: SMALL MOLECULE DRUGS.
- k5 \9 \% f) i, g3.1 Introduction.. h3 i7 o3 p" E; O) a7 o1 y
3.2 Irrational Approach.
L3 q+ x. z* N6 e* f! h3.3 Rational Approach.
6 [8 ^9 Y0 Q6 e k- Z/ H2 t3 A3.4 Antisense Approach.6 y7 n7 e* W8 y$ a( W
3.5 RNA Interference Approach.
7 b, L; s) c( [* G: m3.6 Chiral Drugs.! a$ F0 D, M" q% p. ?! t
3.7 Closing Remarks.1 h1 N S- X( e* j
3.8 Case Study #3.) p& B5 E& {* B2 u4 @9 e
3.9 Summary of Important Points.
$ f* M9 h9 l) N, r) ~3.10 Review Questions.9 a* |/ ~5 t) \; C
3.11 Brief Answers and Explanations.
2 c7 f( k4 E2 ~( Y- e% f3.12 Further Reading.- H% Q1 s+ v. m) O
4 DRUG DISCOVERY: LARGE MOLECULE DRUGS.0 f9 r( n" ?# q: @$ h9 P7 U5 S
4.1 Introduction., j2 L8 B7 A4 g3 j3 A
4.2 Vaccines.
9 Y: h( N; a# n4.3 Antibodies.
0 F1 _0 `0 ]6 e! T4.4 Cytokines.
) e$ e2 \$ R* H# e1 O; x4.5 Hormones.
$ w# V8 h' l2 F" \! R4.6 Gene Therapy.
; G) s7 P) y+ o6 j1 ]! N$ _1 C4.7 Stem Cells and Cell Therapy.
4 Y! |0 ~+ ^: m% d5 x4.8 Case Study #4.' L& u5 t" i. q" N8 K
4.9 Summary of Important Points.6 A1 D3 x( s% w- ]
4.10 Review Questions.
) p- r% x$ P& R1 G/ F' D4.11 Brief Answers and Explanations.
8 Z5 G. \7 R- B( `0 _4.12 Further Reading.8 }! F$ T0 @: e, C
5 DRUG DEVELOPMENT AND PRECLINICAL STUDIES.* x6 ?! a% h5 U( x; W8 o' H b
5.1 Introduction.
9 e# i! w4 N! K8 V' o8 O5.2 Pharmacodynamics.
|% [, A4 n: ^/ c \; V5.3 Pharmacokinetics.
+ c' _, |) }1 t5 \2 ]- Y' u; t5.4 Toxicology.
h4 ?/ P8 {6 y1 d5.5 Animal Tests, In Vitro Assays, and In Silico Methods.( k. M$ ^8 m9 L* [2 ?$ K
5.6 Formulations and Delivery Systems.
; t# ~6 Z/ M9 F5.7 Nanotechnology.
, F* N+ V+ [3 s+ M2 o9 I5.8 Case Study #5.
$ {$ x4 L) ^* A! K5.9 Summary of Important Points.( q0 e- g- [7 j
5.10 Review Questions.! r$ w8 ^+ n/ J$ }- e9 `
5.11 Brief Answers and Explanations.2 L- l9 o4 G9 W7 l5 F8 |7 D
5.12 Further Reading.
" p6 `8 G0 F! p3 |+ i) I+ z9 P6 CLINICAL TRIALS.
/ |& _, A% B5 b% t7 b+ @$ h6.1 Defi nition of Clinical Trial./ W: Y6 j' L8 ^# p4 ^0 y
6.2 Ethical Considerations.2 h% d) Q) ]) h. }7 W& \
6.3 Clinical Trials.- V" \9 J# { i9 `, _0 {* _
6.4 Regulatory Requirements for Clinical Trials.) p6 g' r7 F2 B/ g3 y0 c
6.5 Role of Regulatory Authorities.$ e" Y, R) {" \+ y2 a }8 n+ i
6.6 Gene Therapy Clinical Trial.8 Q, g2 F' z5 P/ m
6.7 Case Study #6.
/ M7 ?+ l" b9 ?4 q j6.8 Summary of Important Points., D b" q5 }3 V: D# L
6.9 Review Questions.
- ]$ p2 C. x$ ^) T; }0 x6.10 Brief Answers and Explanations.- m) {! M) u7 a: X7 s: Z* P
6.11 Further Reading.) _- y/ |0 Q. { M4 s
7 REGULATORY AUTHORITIES.$ _) K; l% O8 A" q" i- v( v& s
7.1 Role of Regulatory Authorities.
7 M% f& M6 K1 z' M2 f; p2 c7.2 US Food and Drug Administration.$ [6 D4 _% u ^' v3 k7 Q( I
7.3 European Medicines Agency.
c0 c, a$ Z, h- |6 q3 R7 T5 b7.4 Japan’s Ministry of Health, Labor and Welfare.
: y2 F* m" U8 \0 n4 |7.5 China’s State Food and Drug Administration.
: ]& ~" c R) J" I7.6 India’s Central Drugs Standard Control Organization.1 \& H$ A# q$ S8 R: r* y# c* [
7.7 Australia’s Therapeutics Goods Administration.+ T4 m$ [9 n) H0 ?/ X# T+ S
7.8 Canada’s Health Canada.# w7 g# N" |. I6 N% B
7.9 Other Regulatory Authorities.
5 Q' i& l! q% ~6 ^! R" O. p7.10 Authorities Other than Drug Regulatory Agencies.
0 k3 z: r( G# L; N- W# U% Q7.11 International Conference on Harmonization.
1 L- T; V! v- a. f3 }7.12 World Health Organization.
2 |3 I2 [ i1 y7.13 Pharmaceutical Inspection Cooperation Scheme.% V; w/ l( K# V
7.14 Case Study #7.. B* G3 Y0 E) d/ \) r$ o" ~" Z
7.15 Summary of Important Points.
- ]3 u. R9 w0 `6 v/ [7.16 Review Questions.
+ I: r! m& Y# b2 ]& C* o& j* t7.17 Brief Answers and Explanations., l2 F) n! Y" r, \) r
7.18 Further Reading.. m3 F$ y' Z+ P) Z* n4 x
8 REGULATORY APPLICATIONS.
4 k, u* y9 J5 V2 f9 j8.1 Introduction.# N% s! R% k& {: j8 [: Y9 b
8.2 Food and Drug Administration.
+ b4 _* v8 k. U" H9 b8.3 European Union.
/ C' x8 I r4 X5 @' O$ d. F+ F1 V8.4 Japan.
m$ P8 O: g0 `: ~$ e# O8.5 China.1 d1 O) D6 |2 q- N$ q" t/ f
8.6 India.
5 L3 x0 {$ R H% P5 K6 y! V1 G8.7 Australia.5 A% i- B) Z3 v% D0 r0 Y) G
8.8 Canada.
' B: x: ~; |+ Z. c9 J. P8.9 Case Study #8.
% M# X3 D n0 a7 B, o `8.10 Summary of Important Points.
+ i: M4 J, U* N. {. b) @8.11 Review Questions.1 \0 L m9 ]: G$ {) y
8.12 Brief Answers and Explanations.
1 n1 o1 E z' o; Q1 B5 X U8.13 Further Reading.1 p6 q; |6 R8 D/ c7 W" ~5 s
9 GOOD MANUFACTURING PRACTICE: REGULATORY REQUIREMENT." S" I7 i, z" n8 b" C
9.1 Introduction.
- @, C* }" o" M% p- N6 K9.2 United States.3 S6 r- }: p& ]" @
9.3 Europe.
: i- v7 F* e/ n7 N9.4 International Conference on Harmonization.
/ N9 B5 Q, }6 S) b# p# c$ b8 @9.5 Core Elements of GMP.
% b* F1 B5 Z6 _. B9.6 Selected GMP Systems.' z7 K6 r! r5 c+ g" g2 h
9.7 The FDA’s New cGMP Initiative." l' I. l2 E' ^! F4 r
9.8 Case Study #9.
* I: E1 d! m0 `+ Z, F& r- n9.9 Summary of Important Points.
2 u0 O# |) D- M' ~& f9.10 Review Questions.
, t% s& F( Y1 e- ~9.11 Brief Answers and Explanations.
3 ^5 j+ r0 D' g9 W# h$ X9.12 Further Reading.
4 j7 K1 I7 }" y, s) w10 GOOD MANUFACTURING PRACTICE: DRUG MANUFACTURING.5 @' V* |2 W s4 m8 r+ k4 p
10.1 Introduction.
( s7 G2 R. _; x5 }8 E' y3 |# o10.2 GMP Manufacturing.
( \" I0 S! L. i! d10.3 GMP Inspection.7 i" n1 ~" i# m3 A+ ~
10.4 Manufacture of Small Molecule APIs (Chemical Synthesis Methods).( N/ R3 R: {: l' h, U3 w" `- H3 u. X7 g
10.5 Manufacture of Large Molecule APIs (Recombirant DNA Methods).* x4 O& J: G7 S8 M3 y% a- J- N
10.6 Finished Dosage Forms.
& j" c2 z7 q6 M5 ^4 q11 FUTURE PERSPECTIVES." J6 l. C5 ], B2 F4 v( X
11.1 Past Advances and Future Challenges.
! C( \2 i* S+ J( Y+ z11.2 Small Molecule Pharmaceutical Drugs." j7 I: _% I6 E
11.3 Large Molecule Biopharmaceutical Drugs.9 l$ k( \1 @3 O+ B! m! Q
11.4 Traditional Medicine.: [0 C0 m; t" _
11.5 Individualized Medicine.
6 g" G- E5 I$ OAPPENDIX 1 HISTORY OF DRUG DISCOVERY AND DEVELOPMENT.
- ~$ J F! u; k. H& F4 l, y, mA1.1 Early History of Medicine.8 C. G6 h- S' F0 S8 y( K
A1.2 Drug Discovery and Development in the Middle Ages.1 L& ^8 T9 d5 u$ U$ H) n) d( W$ ?
A1.3 Foundation of Current Drug Discovery and Development.9 }) r0 J' }) e! \- T
A1.4 Beginnings of Modern Pharmaceutical Industry.
! A2 _1 h. M9 `/ { z3 [# ZA1.5 Evolution of Drug Products.3 B& ?/ M, F; c. D! Y: R
A1.6 Further Reading.' J" _% G% t; Y4 S ?
APPENDIX 2 CELLS, NUCLEIC ACIDS, GENES, AND PROTEINS.
$ R; V9 A( N/ A$ r mA2.1 Cells.
( Q& f" q/ r$ s2 CA2.2 Nucleic Acids.
) n( f$ O! t( K! EA2.3 Genes and Proteins.
# F( @* P$ C# ` W5 T, J. DA2.4 Further Reading.
- x7 d) M8 d1 o$ S# AAPPENDIX 3 SELECTED DRUGS AND THEIR MECHANISMS OF ACTION.
( \# X& e+ p" c% S+ ?APPENDIX 4 A DHFR PLASMID VECTOR.0 S+ q; b& x) v0 J
APPENDIX 5 VACCINE PRODUCTION METHODS." \+ @5 T. \/ b8 V4 L" p6 f
APPENDIX 6 PHARMACOLOGY/ TOXICOLOGY./ x/ V* R- n# X
REVIEW FORMAT.
9 i6 S E5 p+ `; \APPENDIX 7 EXAMPLES OF GENERAL BIOMARKERS.
# m0 }: g8 a5 eAPPENDIX 8 TOXICITY GRADING.& e( p4 o( S+ R2 I- Z6 w
APPENDIX 9 HEALTH SYSTEMS IN SELECTED COUNTRIES.
$ a7 ^# r$ @( d6 zACRONYMS./ H; \0 D4 h, T+ C( [. V
GLOSSARY.1 F, n, j2 ^* j m* T. |% x5 v: V
INDEX.- ^, D5 B5 j7 g1 V- `+ m7 E( s
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