A DETAILED REVIEW ON PERSONALIZED MEDICINE PersonalizedMedicine or customizedMedicine refers to the fitting of remedial treatment to the individual qualityof every patient. It doesn’t mean the formation of medications or therapeutic devicethat are one of a kind to a patient, however the capacity to group patientsinto subpopulations that vary in their reaction to a particular treatment. Helpfulappeal can be focused on those patients who will profit, saving cost and noreactions.
ELEMENT1″Theright patient with the right drug at the right dose at the right time” PERSONALIZED MEDICINEWith the growth of the pharmaceutical andmedical device industries in the 20th century came the rise ofgenetics, imaging and data mining. But the differences in response to drugs inthe variations of human genome served as the foundation of pharmacogenetics. At the turn of 21st century, A setin motion for the transformation of personalized medicine to from an idea topractice.
Generally, the patient’s doctor makes adecision about the medication based on only general information for thedisease. This trial and error approach can lead to patient dissatisfactions,adverse drug responses and drug interactions and poor adherence to treatmentregimens.The main goal of personalized medicine isto reduce healthcare costs by improving our ability to quickly and reliablyselect effective therapy for a given patient while minimizing costs associatedwith ineffective treatment and avoidable adverse events. Stratification is acore element of personalized medicine.Pharmacogenomicsis an investigation of varieties of DNA and RNA characteristics as related todrug response is the most important area in personalized medicine.
Personalized medicine generally involves two medical products: 1. Diagnostic device (invitro tests) &(in vivo tests) 2. Therapeutic productMany medical device therapies have beentailored to specific patient characteristics include patient anatomy,physiology and environment of use.Additional physiological sensors usedrecently like three-dimensional printing based on image of a patient’s anatomy.Before the inlet of personalized medicine,there exit a situation in which everyone gets the same dose of a drug,regardless of genotype.Thus, after the approach of personalizedmedicine in which the dose of the drug is selected based upon Geno typical andtherefore phenotypical, variability of the metabolizing enzyme.Responsibilities of FDA:FDA’S aim is to protect and promote thehealth of all Americans through assuring the safety, efficacy, security ofdrugs, biologics and medical devices.
Each year, Americans consumes 20 cents ofevery dollar of FDA- regulated products.Themain job of FDA: 1. Isto determines that products are safe and effective before marketing after acertain evaluation of benefits and risks.
2. Itmust also require manufactures to follow quality manufacturing practices andprocess and must conduct post-market surveillance. 3. Themain thing in which the FDA strives to advance the public health by helping tospeed access to innovative medical products. The mission of FDA is a series ofinstitutional responsibilities that are key to the emergence and direction ofthe field of personalized medicine which includes:· The main responsibilityis to carefully consider the benefits and risks during the evaluation ofmedical products into the innovative product while assuring proper patientsprotection.· The new advances ofscience facts and technology must be stay along to produce an innovativemedical product.· In order to increase thenew development of medical product, they must encourage to provide clarity& predictability and guidance to industry.· The latest information ofscience, technology and facts must be used appropriately and rationally toinform clinical trial design, drug and device development and clinicalpractice.
· To evaluate and validatenew diagnostics and therapeutics, FDA must work together with universityscientists, government agencies, including NIH, companies, standardsorganizations, practicing physicians and patients.· New safer and effectivedrugs and medical devices are streamlined for regulatory process and advancingthe science and tools that will help drive innovation. Every medical product has inherent risks, but FDA’sjob is to determine if the benefit exceeds the risk in the targeted populationsas a whole.It can be approved as “safe and effective” only whenthat product has some scientific evidence during the clinical trials to thecertain group of patients who has same diseases with similar characteristics.But the response varies from one individual to thenext as a result of genetic and environment factors, as well as the interactionof these factors.
As a result, from this information the drugs must notbe used for every patient based on only the general information, thus improvingthe safety and efficacy of drugs by specifying the populations in which theymust be used. When the targeted populations were givencertain drugs to the targeted disease or condition based on only the generalinformation have different rates of efficacy as follows:Depression -38% Asthma-40%Cardiac Arrythmias-40%Diabetes-43%Migraine-48%Arthritis-50%Osteoporosis-52%Alzheimer’s-70%Cancer-75%Thus, with the helpof personalized medicine, the healthcare management paradigm will focus onprevention, moving from illness to wellness, and from treating disease tomaintaining health and improving the success rates.