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The views expressed in this chapter are those of the authors and do not necessarily represent the views or the opinions of Medicines Control Agency, other regulatory authorities or any of their advisory committees.
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References
Ariëns EJ, Wuis EW, Verings EJ (1988) Stereoselectivity of bioactive xenobiotics. Biochem Pharmacol 37:9–15
Coronary Drug Project Research Group (1972) The Coronary Drug Project: Findings leading to further modifications of its protocol with respect to dextrothyroxine. JAMA 220:996–1008
Cushny AR (1926) Biological relations of optically isomeric substances. Balliere, Tindall and Cox, London
Dakers JM, Boulton DW, Fawcett JP (1997) Sensitive chiral high-performance liquid chromatographic assay for labetalol in biological fluids. J Chromatogr B Biomed Sci Appl 704:215–220
Eudralex (1998) The rules governing medicinal products in the European Union, Vols 1-9, Office for Official Publications of the European Communities, Luxembourg, 1998
Fromm GH, Terrence CF (1987) Comparison of L-baclofen and racemic baclofen in trigeminal neuralgia. Neurology 37:1725–1728
Fujimura A, Ohashi K, Tsuru M, Ebihara A, Kondo K (1989) Clinical pharmacology of dilevalol (I). Comparison of the pharmacokinetic and pharmacodynamic properties of dilevalol and labetalol after a single oral administration in healthy subjects. J Clin Pharmacol 29:635–642
Gristwood R, Bardsley H, Baker H, Dickens J (1994) Reduced cardiotoxicity of levobupivacaine compared to racemic bupivacaine (Marcaine): new clinical evidence. Exp Opin Invest Drugs 3:1209–1212
Hamon P, Dingeon B, Jiang N-S, Orgiazzi J (1993) Purified D-thyroxine in athyreotic patients. Lancet 341:1477
Hutt AJ, Tan SC (1996) Drug chirality and its clinical significance. Drugs 52[Suppl 5]:1–12
Jenner P, Testa B (1973) Influence of stereochemical factors on drug disposition. Drug Metab Rev 2:117–184
Mauleon D, Artigas R, Garcia ML, Carganico G (1996) Pre-clinical and clinical development of dexketoprofen. Drugs 52[Suppl 5]:24–46
McClellan KJ, Spencer CM (1998) Levobupivacaine. Drugs 56:355–362
Millership JS, Fitzpatrick A (1993) Commonly used chiral drugs: a survey. Chirality 5:573–576
Pagnan A, Busnardo B, Zanetti G, Simioni N, Braggion M, Ziron L, Girelli ME (1984) Effects of dextro-thyroxine, a preparation almost free of levo-thyroxine, on thyroid function, serum lipids and apolipoprotein A-l in “double pre-beta lipoproteinemia”. Atherosclerosis 50:191–202
Rauws AG, Groen K (1994) Current regulatory (draft) guidance on chiral medicinal products: Canada, EEC, Japan, United States. Chirality 6:72–75
Ruffolo RR Jr, Spradlin TA, Pollock GD, Waddell JE, Murphy PJ (1981) Alpha and beta adrenergic effects of the stereoisomers of dobutamine. J Pharmacol Exp Ther 219:447–452
Ruffolo RR Jr, Messick K (1985) Systemic hemodynamic effects of dopamine, (+/-)-dobutamine and the (+)-and (-)-enantiomers of dobutamine in anesthetized normotensive rats. Eur J Pharmacol 109:173–181
Shah RR, Midgley JM, Branch SK (1998) Stereochemical origin of some clinically significant drug safety concerns: lessons for future drug development. Adverse Drug React Toxicol Rev 17:145–190
Shindo H, Caldwell J (1991) Regulatory aspects of the development of chiral drugs in Japan: a status report. Chirality 3:91–93
Shindo H, Caldwell J (1995) Development of chiral drugs in Japan: an update on regulatory and industrial opinion. Chirality 7:349–352
Tenero DM, Bottorff MB, Given BD, Kramer WG, Affrime MB, Patrick JE, Lalonde RL (1989) Pharmacokinetics and pharmacodynamics of dilevalol. Clin Pharmacol Ther 46:648–656
Triggle DJ (1997) Drug Discovery Today 2:138–147
Tucker GT (1999) Chiral switches. Lancet 355:1085–1087
Valenzuela C, Snyders DJ, Bennet PB, Tamargo J, Hondeghem LM (1995a) Stereoselective block of cardiac sodium channels by bupivacaine in guinea-pig ventricular myocytes. Circulation 92:3014–3024
Valenzuela C, Delpon E,T amkun MM, Tamargo J, Snyders DJ (1995b) Stereoselective block of a human cardiac potassium channel (Kvl.5) by bupivacaine enantiomers. Biophys J 69:418–427
Young WF Jr, Gorman CA, Jiang NS, Machacek D, Hay ID (1984) L-thyroxine contamination of pharmaceutical D-thyroxine: probable cause of therapeutic effect. Clin Pharmacol Ther 36:781–787
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Shah, R.R., Branch, S.K. (2003). Regulatory Requirements for the Development of Chirally Active Drugs. In: Eichelbaum, M., Testa, B., Somogyi, A. (eds) Stereochemical Aspects of Drug Action and Disposition. Handbook of Experimental Pharmacology, vol 153. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-55842-9_16
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