Clinical drug development

Kuhlmann J. Alternative strategies in drug development clinical pharmacological aspects. Int J Clin Pharmacol Ther 1999 37[12] 575—583. 

In order to expedite and optimise drug development, clinical trials are now conducted in different parts of the world. Recognising that drug development is a global process and in order that the data from one ethnic group can... 

Barrett JS Bioavailability and bioequivalence studies. In Bonate PL, Howard DR (Eds.), Pharmacokinetics in Drug Development Clinical Study Design and Analysis, Volume 1. AAPS Press, Arlington,VA (2004). 

Guarino, R.A. Practice and Application of Good Clinical Practices. Concepts and Strategies in New Drug Development Clinical Pharmacology and Therapeutic Series Praeger Publishers New York, 1983 4. 

Although there are currently many analytical and modeling challenges with these data sets, further improvements in these technologies will engender applications in drug development, clinical research, and patient care. 

FTIH studies present the drug developer/clinical researcher with the first opportunity to study a new molecular entity (NME) in humans and are pivotal to early... 

Mahmood, I. Interspecies pharmacokinetic scaling Principles, applications, and limitations. In Pharmacokinetics in drug development Clinical study design and analysis. (Bonate, P.L., and Howard, D., Eds.). AAPS Press, Alexandria, VA, 2004, pp. 423-444. 

Bonate, P., Reith, K., Weir, S. (1998). Drug interactions at the renal level Implications for drug development. Clinical Pharmacokinetics, 34, 375-404. 

Kelloff, G.J. et al.. Strategy and planning for chemopreventive drug development clinical development plans beta-carotene and other carotenoids, J. Cell Biochem., 20 (Suppl.), 110, 1994. 

Nation, R.L. Chirality in new drug development. Clinical pharmacokinetic considerations. Clin. Pharmacokin. 1994, 27, 249-255. 

The second example of development and validation of an analytical method for pharmacokinetic studies of a candidate compound in drug development (clinical studies) concerns an additional complication rather different from the enantiomeric distinction discussed above. In this case (Sennbro 2006) the drug candidate (laquinimod) was a synthetic compound intended for oral treatment of multiple sclerosis. In pre-clinical studies the pharmacokinetics in animal models had been determined using... 

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