Clinical pharmacokinetic registration file for NDA and ANDA procedures

Pharmacological Research : the Official Journal of the Italian Pharmacological Society
A Marzo

Abstract

Pharmacokinetics is a relatively young branch of the life sciences, which has developed rapidly in the last 15-20 years, thanks to a series of analytical achievements that have allowed drug concentrations to be measured in biological matrices with highly selective and sensitive methods. Most old drugs and all new drugs have been investigated in depth to determine their absorption, distribution, metabolism and elimination. This has produced a huge body of data which have characterized drugs through so-called fingerprint parameters. Today, pharmacokinetics plays a vital role throughout drug development from initial non-clinical studies to clinical trials. In new drug development, simultaneous efforts in pharmacodynamic and pharmacokinetic studies have produced a high degree of synergy, the most useful expression of which is the identification of a therapeutic window, where this can be achieved. Dose linearity/proportionality, gender effect, metabolism and possible polymorphism, studies on neonates/children and on elderly and diseased patients and the population approach, relative and absolute bioavailability, possible interactions and the possible presence of a deep compartment in the distribution are other important applications...Continue Reading

Citations

Nov 28, 2013·PloS One·Katja TrobecMitja Lainscak
May 20, 2014·Pharmacological Research : the Official Journal of the Italian Pharmacological Society·Corrado BlandizziCarmelo Scarpignato
Mar 3, 1999·The Journal of Pharmacy and Pharmacology·A Marzo
Mar 5, 2014·Journal of Pharmaceutical Sciences·Laysa Pires De Figueiredo, Fabio Furlan Ferreira
Mar 19, 2005·Transplant International : Official Journal of the European Society for Organ Transplantation·Dario CattaneoGiuseppe Remuzzi
Oct 21, 1999·Pharmacological Research : the Official Journal of the Italian Pharmacological Society·A Marzo
Nov 4, 2000·Pharmacological Research : the Official Journal of the Italian Pharmacological Society·A MarzoF Crivelli
Nov 14, 2015·Metabolic Brain Disease·Rodrigo Binkowski de AndradeClovis Milton Duval Wannmacher
Feb 24, 2001·Journal of Chromatography. a·S Ulrich

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