Lecture 8 BLG 699.pdf - Another Factor in Drug development...

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Another Factor in Drug development Pre Clinical Testing and Animal testing
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- models-in-toxicological-studies
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What is an ideal drug? What are we testing on animals? How about alternate to Animals? What are three R’s Impact of three Rs Canadian Council On Animal Care-(CCAC) Regulatory authority for ethical use of animal in research ARRIVE guidelines What are they? Why they are needed
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An ideal drug is potent, efficacious, and specific; strong effects on a specific targeted biological pathway and minimal effects on all other pathways, to reduce side effects. In reality, no drugs are perfectly effective and absolutely safe. (Ng 137) Ng, Rick. Drugs: From Discovery to Approval . Wiley-Blackwell (STMS), 11/2015.
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depend on the chemical and structural specificity of drug target interaction PD, PK and toxicity PD deals with the actions of the drug on the target, PK is about the actions of the body on the drug. Toxicity information in pre-clinical studies provides us with confidence in the safety aspect of the potential drug. These data for PD, PK, and toxicity enable the dose and dosing regimen to be set for the clinical trials. (Ng 137) Ng, Rick. Drugs: From Discovery to Approval . Wiley-Blackwell (STMS), 11/2008. VitalBook file.
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Potency : This is the dose required to generate an effect. A potent drug elicits an effect at a low dose. Effectiveness : This is the intensity of the effect or response. It is a measure of the affinity of the drug for the receptor. An effective drug is one that can achieve effects in the vicinity of E max. (Ng 156) Ng, Rick. Drugs: From Discovery to Approval, 3rd Edition . Wiley-Blackwell, 2015- 04-30. VitalBook file.
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is the study of the kinetics of absorption, distribution, metabolism, and excretion (ADME) of drugs OK- If you have a headache.. what do you do? What do you take? Then what happen after?
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Define and understand any organ’s toxicity Acute Toxicity studies Carcinogenicity Repeat dose studies Reproductive studies Genotoxicity studies or mutagenicity studies Immunotoxicity or juvenile toxicity studies
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2 mammalian species Test the clinical and parenteral routes Single dose studies Dose escalation studies - development/safety-testing/
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Conducted for the period of time consistent with therapeutic indication(how long the drug is given for) And to the length of the clinical program Two non human mammalian species (one rodent and one non-rodent species) Should equal or exceed clinical trials - development/safety-testing/
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2 years in rats and 18 months in mice for non carcinogen product Not always required Life threatening diseases Known carcinogens Done in late development stage after efficacy studies - development/safety-testing/
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