Preclinical Development Primer 201 | CPE

- Level: Intermediate
- CPE: 1.0 Credits
- Time: 55 Minutes
Learn what it takes to meet regulatory standards and successfully file an IND application with Preclinical Development Primer 201. Analyze a real-world one-month rat study to gain first-hand experience of pharmacology and safety testing, like ADME, hERG, and carcinogenicity, to support a strong IND.
- Understand how animal models are used to support preclinical drug development
- Explore the role of pharmacokinetics and pharmacodynamics in evaluating drug candidates
- Recognize how dose levels and routes of administration in animals relate to human applications
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- Overview
- Agenda
- Features
- Justify This Training
- FAQ
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Agenda
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Overview
Introduces key preclinical development metrics, including pharmacology and toxicology, to inform trial design and regulatory approval.
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Pharmacology
Explores core pharmacology concepts, including binding assays based on the Law of Mass Action, dose-response curves for potency and efficacy, and mechanisms of action for agonists and antagonists.
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Pharmacokinetics
Focuses on PD and PK measurements, including the ADME of drugs and bioanalytical assays to determine API concentration, informing dose, frequency, and route of administration.
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Toxicology
Describes the complexities of in vivo models, focusing on concordance between animal and human toxicities, and the importance of therapeutic margins and adverse effects.
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Nonclinical IND/CTA
Reviews the various types of INDs and the role of the Common Technical Document (CTD) in IND and CTA filings.
Features
- Closed Captioning in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
- Transcripts in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
- Course materials
- Real-time tracking
- Progress reporting
- Accessibility features
- Corporate account upgrades
- LinkedIn certificate attachment
- Verified certificates
Justify This Training
View our “Justify This Training” checklist and letter to craft a persuasive request that clearly shows the value of Biotech Primer training to your role and your company. This step-by-step guide helps you highlight ROI, align with business goals, and increase your chances of getting this course approved.
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