There are a variety of analysis methods available to characterize PK/PD relationships. While a specific approach cannot be recommended in general for the regulatory purposes it can be stated that PK/PD modeling normally is more informative than other approaches. With respect to characterizing the PK/PD, an important point is what assumptions have been made during the model-building process. These assumptions concern the accuracy of the data; that the structural model fit data appropriate. The study of Rasaushadies with radioisotopes on this basis, the literature though not available at this hour, the concept of ideal experimental model and mechanism is a need of the hour to prove its mysterious actions. Here are some of the most reliable techniques mentioned for the experimental models and to decide the ideal.
Background materials: Selected articles related to PK/PD studies and radioisotopes.
Method: A retrospective and prospective logical scientific literary research.
Discussion and conclusion: The studies should focus on those models most important to the indications sought and might incorporate a comparison of PK/PD parameters between the actual drug whether a single drug or a yoga and the structurally related compounds (For eg: Kajjali with Rasasindoora tagged with the radioisotope mercury to observe the differential actions). The microdialysis technique is a unique research tool that allows the simultaneous determination of unbound concentrations of drugs at several tissues and its action on biochemical and clinical markers during several hours and days. Therefore, microdialysis sampling is an attractive methodology for PK–PD studies. The link between the pre-clinically established PK/PD relationship and its potential to predict clinical outcome in human disease is based on retrospective analyses of individual clinical trials in man or pooling of those trials. Very few clinical trials available in the literature have attempted to prospectively validate the predictive capacity of PK/PD data for clinical outcomes.Nevertheless,the available data from appropriate models indicate that similar PK/PD relationships exist in human diseases as have been seen in animal experimental diseases. No single experimental approach or model is capable of answering all of the biologic questions surrounding wear-induced diseases. However, all three approaches (in vitro, in vivo, and tissue retrieval) may prove useful and may improve the understanding of this complex process. . Because the clinical phenotype of diseases remains multifactorial and complex, it is unlikely that any single approach will be able to replicate the clinical scenario. This does not invalidate the use of each of these models because basic principles of ayurveda, rasashastra and approaches to treatment can still employ these models and validate potential therapeutic approaches with the ultimate goal being to make the science sustain with safe and effective drugs.
A good thought, and a study should be carried out in this manner and many major organizations like IIIM, UDCT etc are carrying out such radio isotope labelled Kajjali, studies.
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