By P. G. Welling (auth.), Peter G. Welling Ph.D., D.Sc., Luc P. Balant Ph.D. (eds.)
The writer of this Foreword has lately retired after spending 25 years in academia and 15 years within the pharmaceutical undefined. such a lot of this time has been spent following and, confidently in a few circumstances, contributing to development of the self-discipline of pharmacokinetics. over the past forty years, pharmacokinetics has grown from a fledgling within the Fifties to an grownup within the Nineties. The past due improvement of the self-discipline of pharmacokinetics, relative to different disciplines equivalent to chemistry, bio chemistry, and pharmacology, most likely stems either from basic lack of awareness of the significance of the time process concentration-effect relationships in drug treatment and from our technical lack of ability to do whatever approximately it had we been extra enlightened. simply because the finish of the old darkish a while needed to watch for the start of the Carolingian revival, so the top of the pharma co kinetic darkish age needed to look ahead to the invention of sufficient analytical tools and in addition an highbrow bounce of religion to just accept that drug motion is ultimately depending on receptor web site occupancy, and for this reason on drug con centration. the hot evolution of pharmacokinetics has happened in 3 stages that could be pointed out as these of discovery, stabilization, and rationaliz ation. the invention part, which happened within the Fifties and Nineteen Sixties, esta blished the maths and ideas of "modern" pharmacokinetics and sought parts of program, starting from model-independent equipment, via compartment methods, to complicated physiological models.
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Extra resources for Pharmacokinetics of Drugs
J BioI Chern 59:737-751 Lemberger L (1989) Pharmacokinetics and adverse reactions: an overview. In: Yacobi A, Skelly JP, Batra VK (eds) Toxicokinetics and new drug development. Pergamon, New York, pp 114-123 Nelson E (1961) Kinetics of drug absorption, distribution, metabolism, and excretion. J Pharm Sci 50:181-192 Rowland E, Aarons L (eds) (1992) New strategies in drug development and clinical evaluation: the population approach. Conference, Manchester, UK, September 21-23, 1991. Office for Official Publications of the European Communities, Luxembourg Snow J (1847) On the inhalation of the vapour of ether.
In some instances both single and repeated doses may be desirable_ This consumes a considerable quantity of time, and of radiolabeled drug, but may be necessary in order to adequately characterize disposition and tissue accumulation of radiolabel after single and repeated doses. Autoradiographic data obtained in animals are important for extrapolation to humans since physicochemical properties of tissues are similar across mammalian species_ Inclusion of extensive metabolism work at this stage may be controversial, but this writer is convinced that metabolic characterization of a drug candidate early in a development program is at least as important as, if not more so than, the pharmacokinetic component.
They may include absolute systemic bioavailability relative to parental dosage or relative bioavailability relative to another enteral dosage form, dose proportionality, and relative bioavailability of any reformulated compound that may be used as positive control during subsequent phase 2 or 3 efficacy studies. Ingestion of food is now recognized as being a key factor influencing drug absorption (WELLING 1977; TOOTHAKER and WELLING 1980), and a food-drug interaction study is virtually mandatory during phase 1.