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Volumn , Issue , 2007, Pages 581-609

Secondary Pharmacodynamic Studies and In Vitro Pharmacological Profiling

Author keywords

Absorption, distribution, metabolism, and excretion (ADME) assays; Common Technical Document (CTD); Reverse sequential approach

Indexed keywords


EID: 84889458207     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9780470249055.ch17     Document Type: Chapter
Times cited : (6)

References (53)
  • 1
    • 0011350661 scopus 로고    scopus 로고
    • ICH S7A: Note for Guidance on Safety Pharmacology Studies for Human Pharmaceuticals
    • Anon CPMP/ICH/539/00
    • Anon. ICH S7A: Note for Guidance on Safety Pharmacology Studies for Human Pharmaceuticals. CPMP/ICH/539/00. 2000.
    • (2000)
  • 2
    • 84889472951 scopus 로고
    • Guidelines for General Pharmacology Studies - Japanese Guidelines for Non-clinical Studies of Drugs Manual
    • Anon Tokyo, Japan: Nippo Yakuji 125-129
    • Anon. Guidelines for General Pharmacology Studies - Japanese Guidelines for Non-clinical Studies of Drugs Manual. Tokyo, Japan: Nippo Yakuji; 1995, pp 71-80, pp 125-129.
    • (1995) , pp. 71-80
  • 6
    • 0027933948 scopus 로고
    • Status of safety pharmacology in the pharmaceutical industry - 1993
    • Kinter LB, Gossett KA, Kerns WD. Status of safety pharmacology in the pharmaceutical industry - 1993. Drug Dev Res 1994; 32: 208-216.
    • (1994) Drug Dev Res , vol.32 , pp. 208-216
    • Kinter, L.B.1    Gossett, K.A.2    Kerns, W.D.3
  • 7
    • 2542505942 scopus 로고    scopus 로고
    • Status of international regulatory guidelines on safety pharmacology
    • In Williams PD, Bass AS, Eds. Safety Pharmacology A Practical Guide. TherImmune Research Corporation, USA
    • Bass AS, Williams PD. Status of international regulatory guidelines on safety pharmacology. In Williams PD, Bass AS, Eds. Safety Pharmacology A Practical Guide. TherImmune Research Corporation, USA; 2003, pp 9-20.
    • (2003) , pp. 9-20
    • Bass, A.S.1    Williams, P.D.2
  • 8
    • 0242598120 scopus 로고    scopus 로고
    • ICH M3: Timing of Non-clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals
    • Anon CPMP/ICH/286/95
    • Anon. ICH M3: Timing of Non-clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals. CPMP/ICH/286/95. 1997.
    • (1997)
  • 9
    • 67649255424 scopus 로고    scopus 로고
    • ICH S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
    • Anon CPMP/ICH/302/95
    • Anon. ICH S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals. CPMP/ICH/302/95. 1997.
    • (1997)
  • 10
    • 79960989205 scopus 로고    scopus 로고
    • The GLP Pocket Book: The Good Laboratory Practice Regulations 1999 and Guide to UK GLP Regulations
    • Anon London: MCA Publications
    • Anon. The GLP Pocket Book: The Good Laboratory Practice Regulations 1999 and Guide to UK GLP Regulations. London: MCA Publications; 1999, pp 1-75.
    • (1999) , pp. 1-75
  • 11
    • 34548495501 scopus 로고    scopus 로고
    • ICH S7B: The Non-clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals
    • Anon CPMP/ICH/423/02
    • Anon. ICH S7B: The Non-clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals. CPMP/ICH/423/02. 2005.
    • (2005)
  • 12
    • 33846063317 scopus 로고    scopus 로고
    • Committee for Proprietary Medicinal Products
    • Anon Points to Consider: The Assessment of QT Interval Prolongation by Non-cardiovascular Medicinal Products. CPMP/986/96
    • Anon. Committee for Proprietary Medicinal Products. Points to Consider: The Assessment of QT Interval Prolongation by Non-cardiovascular Medicinal Products. CPMP/986/96. 1997.
    • (1997)
  • 13
    • 84889348956 scopus 로고    scopus 로고
    • Draft Guideline on the Non-clinical Investigation of the Dependence Potential of Medicinal Products
    • Anon EMEA/CHMP/SWP/94227/2004
    • Anon. Draft Guideline on the Non-clinical Investigation of the Dependence Potential of Medicinal Products. EMEA/CHMP/SWP/94227/2004. 2005.
    • (2005)
  • 14
    • 84889364950 scopus 로고    scopus 로고
    • ICH M4: Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use
    • Anon CPMP/ICH/2887/99 rev.2
    • Anon. ICH M4: Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use. CPMP/ICH/2887/99 rev.2. 1999.
    • (1999)
  • 15
    • 0037374498 scopus 로고    scopus 로고
    • The price of innovation: new estimates of drug development costs
    • DiMasi JA, Hansen RW, Grabowski HG. The price of innovation: new estimates of drug development costs. J Health Econ 2003; 22: 151.
    • (2003) J Health Econ , vol.22 , pp. 151
    • DiMasi, J.A.1    Hansen, R.W.2    Grabowski, H.G.3
  • 16
    • 84889458287 scopus 로고    scopus 로고
    • Oral communication: new technologies that may impact drug discovery in the 5-10 year time frame workshop
    • Presented at Biomed Expo, Ann Arbor, Michigan, USA, Data derived from Prous Science, Drug News Prospect
    • Kola I, Rafferty M. Oral communication: new technologies that may impact drug discovery in the 5-10 year time frame workshop. Presented at Biomed Expo, Ann Arbor, Michigan, USA, 2002. Data derived from Prous Science, Drug News Prospect.
    • (2002)
    • Kola, I.1    Rafferty, M.2
  • 17
    • 31044441473 scopus 로고    scopus 로고
    • Pharmacogenetics and the concept of individualized medicine
    • Shastry BS. Pharmacogenetics and the concept of individualized medicine. Pharmacogenetics J 2006; 6: 16-21.
    • (2006) Pharmacogenetics J , vol.6 , pp. 16-21
    • Shastry, B.S.1
  • 18
    • 28544451832 scopus 로고    scopus 로고
    • Cardiovascular drug therapy in elderly patients: specific age-related pharmacokinetic, pharmacodynamic, and therapeutic considerations
    • Mangoni AA. Cardiovascular drug therapy in elderly patients: specific age-related pharmacokinetic, pharmacodynamic, and therapeutic considerations. Drugs Aging 2005; 22: 913-941.
    • (2005) Drugs Aging , vol.22 , pp. 913-941
    • Mangoni, A.A.1
  • 19
    • 24044495268 scopus 로고    scopus 로고
    • Mechanisms of disease: β-adrenergic receptors - alterations in signal transduction and pharmacogenomics in heart failure
    • Feldman DS, Carnes CA, Abraham WT, Bristow MR. Mechanisms of disease: β-adrenergic receptors - alterations in signal transduction and pharmacogenomics in heart failure. Nat Clin Practice Cardiovasc Med 2005; 2: 475-483.
    • (2005) Nat Clin Practice Cardiovasc Med , vol.2 , pp. 475-483
    • Feldman, D.S.1    Carnes, C.A.2    Abraham, W.T.3    Bristow, M.R.4
  • 20
    • 4344645978 scopus 로고    scopus 로고
    • Can the pharmaceutical industry reduce attrition rates?
    • Kola I, Landis J. Can the pharmaceutical industry reduce attrition rates? Nat Rev Drug Discov 2004; 3: 711.
    • (2004) Nat Rev Drug Discov , vol.3 , pp. 711
    • Kola, I.1    Landis, J.2
  • 22
    • 12244275244 scopus 로고    scopus 로고
    • Biological spectra analysis: linking biological activity profiles to molecular structure
    • Fliri AF, Loging WT, Thadeio PF, Volkmann RA. Biological spectra analysis: linking biological activity profiles to molecular structure. Proc Nat Acad Sci USA 2005; 102: 261-266.
    • (2005) Proc Nat Acad Sci USA , vol.102 , pp. 261-266
    • Fliri, A.F.1    Loging, W.T.2    Thadeio, P.F.3    Volkmann, R.A.4
  • 23
    • 32344440237 scopus 로고    scopus 로고
    • Analysis of drug-induced effect patterns to link structure and side effects of medicines
    • Fliri AF, Loging WT, Thadeio PF, Volkmann RA. Analysis of drug-induced effect patterns to link structure and side effects of medicines. Nat Chem Biol 2005; 1: 389-391.
    • (2005) Nat Chem Biol , vol.1 , pp. 389-391
    • Fliri, A.F.1    Loging, W.T.2    Thadeio, P.F.3    Volkmann, R.A.4
  • 24
    • 0030777011 scopus 로고    scopus 로고
    • Species differences in brain adenosine A1 receptor pharmacology revealed by use of xanthine and pyrazolopyridine based antagonists
    • Maemoto T, Finlayson K, Olverman HJ, Akahane A, Horton RW, Butcher SP. Species differences in brain adenosine A1 receptor pharmacology revealed by use of xanthine and pyrazolopyridine based antagonists. Br J Pharmacol 1997; 122: 1202-1208.
    • (1997) Br J Pharmacol , vol.122 , pp. 1202-1208
    • Maemoto, T.1    Finlayson, K.2    Olverman, H.J.3    Akahane, A.4    Horton, R.W.5    Butcher, S.P.6
  • 25
    • 26944446576 scopus 로고    scopus 로고
    • Keynote review: in vitro safety pharmacology profiling: an essential tool for successful drug development
    • Whitebread S, Hamon J, Bojanic D, Urban L. Keynote review: in vitro safety pharmacology profiling: an essential tool for successful drug development. Drug Discov Today 2005; 10: 1421-1433.
    • (2005) Drug Discov Today , vol.10 , pp. 1421-1433
    • Whitebread, S.1    Hamon, J.2    Bojanic, D.3    Urban, L.4
  • 27
    • 33645881669 scopus 로고    scopus 로고
    • Statin safety: a systematic review
    • Law M, Rudnicka AR. Statin safety: a systematic review. Am J Cardiol 2006; 17: S52-S60.
    • (2006) Am J Cardiol , vol.17
    • Law, M.1    Rudnicka, A.R.2
  • 29
    • 33646425592 scopus 로고    scopus 로고
    • Ranolazine: a review of its use in chronic stable angina pectoris
    • Siddiqui MAA, Keam SJ. Ranolazine: a review of its use in chronic stable angina pectoris. Drugs 2006; 66: 693-710.
    • (2006) Drugs , vol.66 , pp. 693-710
    • Siddiqui, M.A.A.1    Keam, S.J.2
  • 30
    • 7544241692 scopus 로고    scopus 로고
    • Arrhythmogenic mechanisms of QT prolonging drugs: is QT prolongation really the problem?
    • Antzelevitch C. Arrhythmogenic mechanisms of QT prolonging drugs: is QT prolongation really the problem? J Electrocardiol 2004; 37 (Suppl): 15-24.
    • (2004) J Electrocardiol , vol.37 , Issue.SUPPL. , pp. 15-24
    • Antzelevitch, C.1
  • 35
    • 3242778566 scopus 로고    scopus 로고
    • Antagonism by ranolazine of the pre- arrhythmic effects of increasing late I Na in guinea-pig ventricular myocytes
    • Song Y, Skrycok JC, Wu L, Belardinelli L. Antagonism by ranolazine of the pre- arrhythmic effects of increasing late I Na in guinea-pig ventricular myocytes. J Cardiovasc Pharmacol 2004; 44: 192-199.
    • (2004) J Cardiovasc Pharmacol , vol.44 , pp. 192-199
    • Song, Y.1    Skrycok, J.C.2    Wu, L.3    Belardinelli, L.4
  • 36
    • 0022558288 scopus 로고
    • Innervation of the iris by individual parasympathetic axons in the adult mouse
    • Jackson PC. Innervation of the iris by individual parasympathetic axons in the adult mouse. J Physiol 1986; 378: 485-495.
    • (1986) J Physiol , vol.378 , pp. 485-495
    • Jackson, P.C.1
  • 38
    • 0031010392 scopus 로고    scopus 로고
    • Expression of muscarinic receptor subtypes (effect of M3 selective antagonist on gastric motility and in rat gastric smooth muscle emptying)
    • Lin S, Kajimura M, Takeuchi K, Kodaira M, Hanai H, Kaneko E. Expression of muscarinic receptor subtypes (effect of M3 selective antagonist on gastric motility and in rat gastric smooth muscle emptying). Dig Dis Sci 1997; 42: 907-914.
    • (1997) Dig Dis Sci , vol.42 , pp. 907-914
    • Lin, S.1    Kajimura, M.2    Takeuchi, K.3    Kodaira, M.4    Hanai, H.5    Kaneko, E.6
  • 39
    • 0024573641 scopus 로고
    • Premedication for upper gastrointestinal endoscopy
    • Ross WA. Premedication for upper gastrointestinal endoscopy. Gastrointest Endosc 1989; 32: 120-126.
    • (1989) Gastrointest Endosc , vol.32 , pp. 120-126
    • Ross, W.A.1
  • 40
    • 33644846418 scopus 로고    scopus 로고
    • Efficacy, tolerability and safety of darifenacin, an M3 selective receptor antagonist: an investigation of warning time in patients with OAB
    • Zinner N, Susset J, Gittelman M, Arguinzoniz M, Rekeda L, Haab F. Efficacy, tolerability and safety of darifenacin, an M3 selective receptor antagonist: an investigation of warning time in patients with OAB. Int J Clin Practice 2006; 60: 119-126.
    • (2006) Int J Clin Practice , vol.60 , pp. 119-126
    • Zinner, N.1    Susset, J.2    Gittelman, M.3    Arguinzoniz, M.4    Rekeda, L.5    Haab, F.6
  • 41
    • 19744368349 scopus 로고    scopus 로고
    • Drug repurposing: identify, develop and commercialize new uses for existing or abandoned drugs. Part II
    • Carley DW. Drug repurposing: identify, develop and commercialize new uses for existing or abandoned drugs. Part I. IDrugs 2005; 8: 306-309.
    • (2005) Drugs , vol.8 , pp. 306-309
    • Carley, D.W.1
  • 42
    • 19744380190 scopus 로고    scopus 로고
    • Drug repurposing: identify, develop and commercialize new uses for existing or abandoned drugs Part III
    • Carley DW. Drug repurposing: identify, develop and commercialize new uses for existing or abandoned drugs. Part II. IDrugs 2005; 8: 310-313.
    • (2005) Drugs , vol.8 , pp. 310-313
    • Carley, D.W.1
  • 43
    • 20844439415 scopus 로고    scopus 로고
    • Why big pharma needs to learn the three " R"s
    • Bradley D. Why big pharma needs to learn the three " R"s. Nat Rev Drug Discov 2005; 4: 446.
    • (2005) Nat Rev Drug Discov , vol.4 , pp. 446
    • Bradley, D.1
  • 44
    • 4344668661 scopus 로고    scopus 로고
    • Drug repositioning: identifying and developing new uses for existing drugs
    • Ashburn TT, Thor KB. Drug repositioning: identifying and developing new uses for existing drugs. Nat Rev Drug Discov 2004; 3: 673-683.
    • (2004) Nat Rev Drug Discov , vol.3 , pp. 673-683
    • Ashburn, T.T.1    Thor, K.B.2
  • 45
    • 0344112253 scopus 로고
    • The effect of anti-histaminic drugs on the performance of trained rats
    • Winter C, Flataker L. The effect of anti-histaminic drugs on the performance of trained rats. J Pharmacol Exp Ther 1951; 101: 156-162.
    • (1951) J Pharmacol Exp Ther , vol.101 , pp. 156-162
    • Winter, C.1    Flataker, L.2
  • 46
    • 0002581944 scopus 로고
    • Pharmacodynamic basis for the use of chlorpromazine in psychiatry
    • Courvoisier S. Pharmacodynamic basis for the use of chlorpromazine in psychiatry. J Clin Exp Psychopathol 1956; 17: 25-37.
    • (1956) J Clin Exp Psychopathol , vol.17 , pp. 25-37
    • Courvoisier, S.1
  • 47
    • 0032864985 scopus 로고    scopus 로고
    • History of modern psychopharmacology: a personal view with an emphasis on anti-depressants
    • Domino EF. History of modern psychopharmacology: a personal view with an emphasis on anti-depressants. Psychosom Med 1999; 61: 591-598.
    • (1999) Psychosom Med , vol.61 , pp. 591-598
    • Domino, E.F.1
  • 48
    • 0342305176 scopus 로고
    • L'hibernation artificielle par MoyEnes pharmacodynamiques et physiques En chirurgie
    • Laborit H, Huguenard P. L'hibernation artificielle par MoyEnes pharmacodynamiques et physiques En chirurgie. J Chir 1951; 67: 631-641.
    • (1951) J Chir , vol.67 , pp. 631-641
    • Laborit, H.1    Huguenard, P.2
  • 49
    • 84885931080 scopus 로고
    • L'hibernation artificielle par moyenes pharmacodynamiques et physiques
    • Laborit H, Huguenard P. L'hibernation artificielle par moyenes pharmacodynamiques et physiques. La Presse Med 1951; 59: 13-29.
    • (1951) La Presse Med , vol.59 , pp. 13-29
    • Laborit, H.1    Huguenard, P.2
  • 50
    • 0000924038 scopus 로고
    • Un nouveau stabilisateur vegetatif (le 4560 RP)
    • Laborit H, Huguenard P, Alluaume R. Un nouveau stabilisateur vegetatif (le 4560 RP). La Presse Med 1952; 60: 206-208.
    • (1952) La Presse Med , vol.60 , pp. 206-208
    • Laborit, H.1    Huguenard, P.2    Alluaume, R.3
  • 51
    • 0002713807 scopus 로고
    • Le traitement des psychoses par une methode neurolytque derive de l'hibernotherapie (Le 4560 R.P. utilise seul. En cure prolongee et continue.)
    • Delay J, Deniker P. Le traitement des psychoses par une methode neurolytque derive de l'hibernotherapie (Le 4560 R.P. utilise seul. En cure prolongee et continue.) CR Congress Med Alien Neruol France 1952; 50: 497-502.
    • (1952) CR Congress Med Alien Neruol France , vol.50 , pp. 497-502
    • Delay, J.1    Deniker, P.2
  • 52
    • 0002047699 scopus 로고
    • Introduction of neuroleptic chemotherapy into psychiatry
    • In Ayd FJ, Blackwell B, Eds, Philadelphia: Lippincott
    • Deniker P. Introduction of neuroleptic chemotherapy into psychiatry. In Ayd FJ, Blackwell B, Eds. Discoveries in Biological Psychiatry. Philadelphia: Lippincott; 1970, pp 155-164.
    • (1970) Discoveries in Biological Psychiatry , pp. 155-164
    • Deniker, P.1
  • 53
    • 78651116398 scopus 로고
    • Effect of chlorpromazine or haloperidol on the formation of 3-methoxytyramine and normetanephrine in mouse brain
    • Carlsson A, Lindquist M. Effect of chlorpromazine or haloperidol on the formation of 3-methoxytyramine and normetanephrine in mouse brain. Acta Pharmacol Toxicol 1963; 20: 140-144.
    • (1963) Acta Pharmacol Toxicol , vol.20 , pp. 140-144
    • Carlsson, A.1    Lindquist, M.2


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