Pharmacokinetics summary

Szeto HH. Maternal-fetal pharmacokinetics Summary and future directions. NIDA Res Monogr 1995 154 203-7. 

In summary, the characteristics of the drug and the disease or condition may suggest a likely route and mode of delivery. Considerable vork is required to develop and optimise an appropriate drug presentation. The suitability of any particular strategy must be verified by undertaking the extensive pharmacodynamic and pharmacokinetic studies that form part of the pre-clinical and clinical trials. 

Written Summary of Pharmacology Tabulated Summary of Pharmacology Written Summary of Pharmacokinetics Tabulated Summary of Pharmacokinetics Written Summary of Toxicology Tabulated Summary of Toxicology... 

A summary of the results of the various pharmacological studies, with particular emphasis on results which may be relevant to the evaluation of the safety of residues of the substance. A.2.1 Pharmacodynamics A.2.2 Pharmacokinetics... 

Han Nl, Lee YS, Choi H, Choi JY, Yun SK, Cho SH, Han JY, Yang JM, Ahn BM, Choi SW, Lee CD, Cha SB, Sun HS, Park DH (2002) PCNA expression and electron microscopic study of acinus-forming hepatocytes in chronic hepatitis B. Korean J Intern Med 17 100-106 Herve F, Urien S, Albengres E, Duche JC, TiUement IP (1994) Drug binding in plasma. A summary of recent trends in the study of drug and hormone binding. Qin Pharmacokinet 26 44-58... 

Summary of Physiologically Based and Classical Pharmacokinetic Models. 

In the present compilation of the distribution and pharmacokinetic data of a dozen xenobiotics studied in the dogfish shark, this species yielded excellent data consistent with what we know from similar studies on terrestrial mammals. The data from the shark occasionaly provided information not available in other animals. Major transport parameters in this fish were shown to be similar to those found in mammals. This aquatic organism handles lipid-soluble pollutants by sequestering them in its fatty liver. Together with a previous summary (23) we have now studied about three dozen xenobiotics in this species. Because of its ease of handling, low cost, abundance, predictive value of transport mechanisms, and well-developed pharmacokinetics, the dogfish shark is an ideal fish species to use as a model to study aquatic pollutants. 

In summary, (oxodioxolyl)methyl esters of carboxylic acid drugs appear to be generally useful as prodrugs. However, more studies are needed to document the structure-metabolism relationships, the relative contribution of enzymatic vs. nonenzymatic reactions in their in vivo activation, the reasons of some failures, their toxic potential, and their pharmacokinetic behavior in humans. 

CUnical pharmacology Summary of the actions of the drug in humans in vitro and in vivo actions in animals if pertinent to human therapeutics pharmacokinetics... 

Table 7.7. A SUMMARY OF THE PHARMACOKINETIC PARAMETERS OF ONDANSETRON IN ANIMALS...

In SUMMARY, it would appear that a detailed knowledge of the pharmacokinetics of the main groups of psychotropic drugs is only of very limited clinical use. This is due to limitations in the methods for the detection of some drugs (e.g. the neuroleptics), the presence of active metabolites which make an important contribution to the therapeutic effect, particularly after chronic administration (e.g. many antidepressants, neuroleptics and anxiolytics), and the lack of a direct correlation between the plasma concentration of the drug and its therapeutic effect. Perhaps the only real advances will be made in this area with the development of brain imaging techniques whereby the concentrations of the active drug in the... 

In view of the regulatory delay that was caused by the need to apply for a CTC, a Statutory Order (SI 1974/498) was made during 1974, to provide an exemption from the need to hold a CTC in such cases, subject to certain conditions. This order applied to trials conducted by doctors and dentists on their own responsibility (DDX). The basis of the clinical trial exemption (CTX) scheme, introduced in 1981, to include studies initiated by the pharmaceutical industry, was that together with a detailed clinical trial protocol and summaries of chemical, pharmaceutical, pharmacological, pharmacokinetic, toxicological and human volunteer studies, a clinical trial in patients may proceed without the need for the additional details normally required for a CTC or Product Licence application. This exemption scheme was based on the requirements that ... 

Module 2 Common technical document summaries Overall common technical document table of contents Introduction Quahty overall summary Non-chnical overview Clinical overview Non-chnical summary Pharmacology Written summary Tabulated summary Pharmacokinetics Written summary Tabulated summary Toxicology... 

The pharmacologic studies indicated that intrinsic pharmacokinetics of 5-FU hinder their ability to reproduce the conditions required for radiosensitization. Indeed, the short half-life of the drug (from hepatic removal) preclude anything other than addictive effects when bolus drug is added to any variety of radiation fractionation scheme. These two sets of requirements together demonstrated that a continuous infusion (in which drug is made present for at least 24 h after each radiation fraction) would be optimal. In summary, 5-FU is a potent radiosensitizer under the following defined circumstances. 

In summary, most data are available on the influence of CYP genes on the pharmacokinetics of antidepressants. Genotype-adjusted dose escalation schemes have already been put forward and should be especially useful in TCA treatment. It has to be noted, though, that all studies concerning dose escalation and response have been performed in depressed patients. Dose-response relationships may, however, be different in patients with anxiety disorders, so that further studies are warranted. 

For FTIH trials, all applications should include a summary of projected free plasma concentrations of the new active substance (NAS) in humans and a brief description of any pharmacokinetic modelling programs used to generate the estimates. A comparison with the concentrations obtained in the nonclinical toxicity studies and projected safety margins should be given. In the same section, an estimate of the extent of the intended pharmacological or pharmacodynamic response at the expected plasma concentrations should be included, with a list of the assumptions used in deriving that estimate. 

Available pharmacokinetic (PK) studies of medications with potential to treat pediatric anxiety disorders have been open studies that examine PK parameters and monitor adverse effects in children and adolescents. None of the pediatric PK studies described below were designed as dose finding studies, and none of the studies were able to describe a clear association between dose or exposure and specific adverse effect. However, pediatric PK data can be useful to guide dosing and adverse effect monitoring to the extent that the weight-adjusted PK parameters inform extrapolation based on comparable studies of adult PK. The following summary of PK studies is based on multiple-dose PK studies. 

However, the information derived from a detailed pharmacokinetic study will help to anticipate potential botanical product-drug interactions, to optimize the bioavailability, the quality, and hence the efficacy of herbal medicines, to support evidence for the synergistic nature of herbal medicines, and to better appreciate the safety and toxicity of the plant. Because pharmacokinetic studies with herbal medicines are often complicated by their chemical complexity and by the fact that the active compounds are often unknown, it could be one future issue to assess bioavailability by measuring surrogate parameters in plasma or tissue instead of directly assaying putative active compounds in the blood. In summary, to use HMPs in an evidence-based approach and to achieve the status rational phytomedicine, more experimental studies are needed to characterize the bioavailability and pharmacokinetics of botanical products. 

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