Pharmacokinetic And Pharmacodynamics Essay

993 Words2 Pages

Pre-clinical testing is performed to Good laboratory practice (GLP) and covers pivotal toxicology & safety pharmacology studies. In preclinical research, scientists test their ideas for new biomedical prevention strategies in laboratory experiments or in animals. “Pharmacokinetics (PK) and pharmacodynamics (PD) can be seen as two sides of the same coin. PK and PD have a definite relationship, assessing how much drug gets to the site of action and then what that action is. Both activities are essential in the complete investigation of the interaction between the drug and body, and play significant roles in both drug development and their continual use in the clinical setting (Institute Of Clinical Research, Clinical Pharmacology Special Interest Group, Pharmacokinetics vs. Pharmacodynamics).” As we discussed above that pharmacokinetic and pharmacodynamics can be seen as two sides of the same coin in order to gain better understanding of their efficacy and safety profiles.” Generally it is possible to make fairly robust predictions of the pharmacokinetic profile in man using in vitro systems and preclinical pharmacokinetic studies. A previously published survey on the causes of failure in drug development indicated that inappropriate pharmacokinetics were a major cause such as; factors as low bioavailability due to high extraction or poor absorption characteristics, short elimination half-life leading to short duration of action and excessive variability due to genetic or environmental factors. This observation has led to an increased emphasis on pharmacokinetic input to the drug discovery process throughout the pharmaceutical industry. However, it is important to realise that this may only permit the rejection of compounds to b... ... middle of paper ... ...mmonly referred to as “the 3Rs”. The 3Rs concept was first described by William Russell and Rex Burch in their 1959 book The Principles of Humane Experimental Technique (Alternative to Animal Testing, 2014, National Institute of Health Sciences) Alternative methods are sometimes more reliable, more accurate, cost-effective, practical, and expedient Alternative testing can be used for in preclinical studies .These methods are vitro methods (human cells and tissues), silico models (advanced computer-modeling techniques), studies with human volunteers (microdosing, advanced brain imaging and recording techniques), stem cell, genetic testing methods, computerized patient-drug databases ,virtual drug trials and human-patient simulators can be used for the assessment of the safety of drugs, chemicals, cosmetics, medical devices, consumer and investigational products.

Open Document