Description:
Preclinical Services, Preclinical Development, Preclinical Testing Definition, Preclinical Trials Phases, Preclinical Studies In Drug Development, Preclinical Vs Clinical Studies. In Drug Development, Preclinical Development, Also Termed Preclinical Studies Or Nonclinical Studies, Is A Stage Of Research That Begins Before Clinical Trials (Testing In Humans) And During Which Important Feasibility, Iterative Testing And Drug Safety Data Are Collected, Typically In Laboratory Animals.\nThe Main Goals Of Preclinical Studies Are To Determine A Starting, Safe Dose For First-In-Human Study And Assess Potential Toxicity Of The Product, Which Typically Include New Medical Devices, Prescription Drugs, And Diagnostics.\nAnimal Testing\nThe Information Collected From These Studies Is Vital So That Safe Human Testing Can Begin. Typically, In Drug Development Studies Animal Testing Involves Two Species. The Most Commonly Used Models Are Murine And Canine, Although Primate And Porcine Are Also Used.\n\nChoice Of Species\nThe Choice Of Species Is Based On Which Will Give The Best Correlation To Human Trials. Differences In The Gut, Enzyme Activity, Circulatory System, Or Other Considerations Make Certain Models More Appropriate Based On The Dosage Form, Site Of Activity, Or Noxious Metabolites. For Example, Canines May Not Be Good Models For Solid Oral Dosage Forms Because The Characteristic Carnivore Intestine Is Underdeveloped Compared To The Omnivore\'S, And Gastric Emptying Rates Are Increased. Also, Rodents Can Not Act As Models For Antibiotic Drugs Because The Resulting Alteration To Their Intestinal Flora Causes Significant Adverse Effects. Depending On A Drug\'S Functional Groups, It May Be Metabolized In Similar Or Different Ways Between Species, Which Will Affect Both Efficacy And Toxicology.\n\nMedical Device Studies Also Use This Basic Premise. Most Studies Are Performed In Larger Species Such As Dogs, Pigs And Sheep Which Allow For Testing In A Similar Sized Model As That Of A Human. In Addition, Some Species Are Used For Similarity In Specific Organs Or Organ System Physiology (Swine For Dermatological And Coronary Stent Studies; Goats For Mammary Implant Studies; Dogs For Gastric And Cancer Studies; Etc.).\n\nImportantly, The Regulatory Guidelines Of Fda, Ema, And Other Similar International And Regional Authorities Usually Require Safety Testing In At Least Two Mammalian Species, Including One Non-Rodent Species, Prior To Human Trials Authorization.[3]\n\nEthical Issues\nAnimal Testing In The Research-Based Pharmaceutical Industry Has Been Reduced In Recent Years Both For Ethical And Cost Reasons. However, Most Research Will Still Involve Animal Based Testing For The Need Of Similarity In Anatomy And Physiology That Is Required For Diverse Product Development.\n
Keywords:
Preclinical Servicescertification Medical Devices,Medical Publications,1Med Sa