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PK/PD modeling has its importance at each step of the drug development [9] [10] and it has shown its usefulness in many diseases. [11] The Food and Drug Administration also provides guidances for Industry to recommend how exposure-response studies should be performed.
An example of a pharmacophore model of the benzodiazepine binding site on the GABA A receptor. [2] White sticks represent the carbon atoms of the benzodiazepine diazepam, while green represents carbon atoms of the nonbenzodiazepine CGS-9896. Red and blue sticks are oxygen and nitrogen atoms that are present in both structures.
The model outputs for a drug can be used in industry (for example, in calculating bioequivalence when designing generic drugs) or in the clinical application of pharmacokinetic concepts. Clinical pharmacokinetics provides many performance guidelines for effective and efficient use of drugs for human-health professionals and in veterinary medicine .
Pharmacodynamics (PD) is the study of the biochemical and physiologic effects of drugs (especially pharmaceutical drugs). The effects can include those manifested within animals (including humans), microorganisms , or combinations of organisms (for example, infection ).
For drug development, the clinical phases start with testing for drug safety in a few human subjects, then expand to many study participants (potentially tens of thousands) to determine if the treatment is effective. [1] Clinical research is conducted on drug candidates, vaccine candidates, new medical devices, and new diagnostic assays.
It also includes the study of existing drugs, their biological properties, and their quantitative structure-activity relationships (QSAR). [1] [2] Medicinal chemistry is a highly interdisciplinary science combining organic chemistry with biochemistry, computational chemistry, pharmacology, molecular biology, statistics, and physical chemistry.
The phrase "drug design" is similar to ligand design (i.e., design of a molecule that will bind tightly to its target). [6] Although design techniques for prediction of binding affinity are reasonably successful, there are many other properties, such as bioavailability, metabolic half-life, and side effects, that first must be optimized before a ligand can become a safe and effictive drug.
Burger's medicinal Chemistry and Drug Discovery. Vol. 1 (6th ed.). New York: Wiley. pp. 1– 48. ISBN 978-0-471-27401-8. Shityakov S, Puskás I, Roewer N, Förster C, Broscheit J (2014). "Three-dimensional quantitative structure-activity relationship and docking studies in a series of anthocyanin derivatives as cytochrome P450 3A4 inhibitors".