logging in or signing up Pharmacology2000 Berenger Download Post to : URL : Related Presentations : Share Add to Flag Embed Email Send to Blogs and Networks Add to Channel Uploaded from authorPOINTLite Insert YouTube videos in PowerPont slides with aS Desktop Copy embed code: Embed: Flash iPad Copy Does not support media & animations WordPress Embed Customize Embed URL: Copy Thumbnail: Copy The presentation is successfully added In Your Favorites. Views: 1426 Category: Entertainment License: All Rights Reserved Like it (0) Dislike it (0) Added: November 16, 2007 This Presentation is Public Favorites: 3 Presentation Description No description available. Comments Posting comment... By: gaurav_4jain (25 month(s) ago) Dear sir , I am very much impress by your this PPT. This may be a very good tool to teach the students about Preclinical pharmacology. Sir i am unable to download this PPT from hear, please send me a copy of this presentation. I ever remain thankful to you. With best wishes and good luck' Gourav Jain Email: email@example.com Saving..... Post Reply Close Saving..... Edit Comment Close Premium member Presentation Transcript Preclinical Pharmacology: Preclinical Pharmacology Pacific BioLabs Hercules, CAPreclinical Pharmacology: Preclinical Pharmacology Early work may be performed in cell cultures, when appropriate Performance of candidate drugs in an animal system provides early evidence of its potential Preclinical Pharmacology: Preclinical Pharmacology Preclinical evaluations use cell culture and animal responses as predictors of human responses with the goals of assuring safety and effectiveness in humans Pharmacology/Toxicology: Pharmacology/Toxicology Preclinical pharm/tox data are used to: Identify target organs/tissues Identify need for specialized safety monitoring Identify toxicological profile Select starting doses/regimens Developing a Strategy: Developing a Strategy Case by case assessment based on clinical application Start with standard methods Postulated mechanism of action will drive more specialized investigations into a drug’s activityDeveloping a Strategy: Developing a Strategy Pharmacokinetics/pharmacodynamics Bioavailability Dose ranging/dose confirmation Potency determination Immunogenicity Custom animal modelsPharmacokinetics: Pharmacokinetics Absorption Distribution Metabolism Excretion Need to track the drug in specimens Bioanalytical determination (“cold”) Radiolabel counts (“hot”) Species: mouse or rat, then dog and/or primate Bioavailability: Bioavailability Compare blood levels of drug delivered by intravenous route to intended route of administration Commonly oral or topical Species: mouse, rat, or rabbit, then dog and/or primateTopical Drug Delivery: Topical Drug Delivery Significant focus on transdermal drug delivery Iontophoretic delivery Passive patch Creams Formulations to promote absorption or deposition Delivery devices require dual assessment as drug and device Specialized studies look at layers of skin Species: rabbit and pig Dose Ranging/Confirmation: Dose Ranging/Confirmation Multiple dose levels to discover optimum therapeutic level Minimum adverse effects (risk vs. benefit) Dose confirmation to verify earlier findings Maintain same species for comparability Species: mouse, rat, dog, primatePotency Determinations: Potency Determinations Some drugs have a readily measured therapeutic effect Insulin, therapeutic toxins Response can be quantified Potency of preparation can be calculated based on dose response compared to standard Immunogenicity: Immunogenicity Development of an immune response to the test article may be desirable or undesirable Studies look at antibody response after multiple doses of the test article over time Species: rabbit Animal Models: Animal Models Simulations of human condition May be normal state in animal that is very similar to human May be a diseased condition that is created in order to be treated Normal Animal Models: Normal Animal Models Cardiovascular system: pigs, dogs, primates Skin: pigs, primates Eye: rabbits Animal Models of Disease: Animal Models of Disease Photo aging in hairless mice Psoriasis in SCID mice Tumors in rats Obesity in mice Transgenic/”knockout” mice Some work, some don’tSummary: Summary Every program is different, tailored to the activity of the test article Use same species throughout pharm/tox program Get regulatory buy in on plan Pacific BioLabs: Pacific BioLabs THANK YOU! You do not have the permission to view this presentation. In order to view it, please contact the author of the presentation.