Half Day Virtual Seminar on Fundamentals of Toxicology

On 09-Nov, 2022 at 09:00 AM - 01:00 PM EDT  | 06:00 AM - 10:00 AM PDT

Duration 4 Hour Instructor-led virtual seminar

Overview of Toxicology Course Online

The non-clinical security calculation for marketing approval of pharmacological products typically comprises general toxicity studies, pharmacological medicine studies, toxicokinetic, and nonclinical pharmacokinetic studies, reproduction toxicity studies, and genotoxicity studies. For drugs that have a singular reason for anxiety or are envisioned for a long extent of use, an evaluation of carcinogenic potential is also required. Other nonclinical studies to assess phototoxicity, immunotoxicity, juvenile animal toxicity, and abuse liability are conducted on a case-by-case basis. For biotechnology-derived products, suitable nonclinical security education should also be shown on a case-by-case basis. Nonclinical safety studies and human clinical trials should be planned and designed to represent an approach that is scientifically and ethically appropriate.

Reasons for You To Join or Attend Toxicology Course Online

The expansion of a pharmacological product is a step-by-step procedure involving an assessment of both animal and human effectiveness and security evidence. The goals of the nonclinical safety evaluation usually comprise a description of deadly effects with respect to board organs, dose need, relationship to exposure, and, when suitable, possible reversibility. This material is used to approximate an initial safe starting dose and dose range for the human trials and to identify parameters for clinical monitoring for potential opposing effects. Thoughtful opposing events and strong-minded in toxicology studies can affect the continuance of drug development. Those involved in drug growth should be aware of what are the toxicology supplies for promotion approval. This will allow non-toxicologists to learn the nonsense and be able to effectively connect with colleagues. In addition, the course will describe the fundamentals of toxicology to allow non-specialists to comprehend the content of a toxicology report. This will be also accomplished with dedicated case studies during the course to enhance learning.

In toxicology, it must be conceivable to differentiate predictable pharmacology from unexpected or abnormal pharmacology. Toxicity should also allow us to rank molecules based on their inherent deadly potential and identify possible opposing effects. These effects should be connected in toxicology with the contact, to measure the attendance of a dose-response. Generally, the toxicology studies should allow inferring from non-clinical data the anthropological state. This will permit the presence of appropriate valuations during scientific development to guarantee that the security of the enrolled subjects (either healthy volunteers or patients) is upheld. Additionally, toxicology studies allow the documentation of patients at higher risk of an adverse event that should be excluded from the initial phases of drug development if this is deemed necessary. The course will cover these aspects that are relevant for non-toxicologists involved in drug development.

Learning Objective

The topics included in the Toxicology Course Online course are as follows:

▪         Basic principles of practical toxicology

▪         Toxicology vocabulary

▪         Ideologies of supervisory toxicology

▪         Role of toxicology in the dissimilar phases of medication expansion

▪         Practical case studies

▪         Definition and role of “toxicokinetic”

▪         Main toxicology studies and related disciplines

▪         Description of the concept of “safety margins”

Agenda

The role of toxicology in drug development

▪         What is toxicology and how is it examined?

▪         Why do we achieve toxicology studies?

▪         The significance of toxicology throughout phases of drug expansion and the cumulative reputation of toxicology in go/no go decisions

▪         Toxicology and the controlling establishments

▪         Toxicology as a policy tool-establishing what is desirable and interpreting results

▪         Interdisciplinary communication in the pharmacological industry - let’s all speak the same language

How do drugs cause toxicity - what do we measure and how do we measure it?

▪         How is toxicity measured? Assessment on Risk vs hazard assessment!

▪         Explanation elementary vocabulary

▪         Measuring suitable dose and security margins for first into man studies

▪         Founding why and what we are studying

▪         Selecting the appropriate species for toxicological evaluation

▪         What toxicological endpoints are measured?

▪         Introducing the range of toxicology study types from single dose to lifetime exposure

The place of toxicology studies in the regulatory world

▪         Supervisory strategies

▪         Impact of ICH on toxicology education

▪         Toxicology data required for clinical trials and submission dossiers

How toxicology testing is constantly evolving

Toxicological disciplines - what are they & how do they differ?

▪         Safety pharmacology

▪         General toxicology

▪         Safety pharmacology

▪         Carcinogenicity

▪         Genetic toxicology

▪         Local tolerance

▪         Reproductive toxicology

Group Discussion and Case Studies

As a toxicologist in your company, you must spend time designing a suitable bundle of security pharmacological medicine and toxicology studies to support original and early clinical experimental work. Planned studies and the rationale for their inclusion will be discussed.

The role of toxicokinetic in toxicology

▪         Fundamentals of toxicokinetic examination

▪         Toxicokinetic measurement in toxicology studies

▪         Founding security margins for scientific investigations

▪         Extrapolation to man: What is the relationship between pre-clinical and clinical toxicology?

Q&A Session

Who Will Benefit

Clinical research associates, medicinal chemists, pharmacologists, toxicologists, project managers, business development managers, medical writers.

FDA Faculty Dr. Stefano Persiani

Faculty Dr. Stefano Persiani 

Internal & External Innovation, Director Translational Sciences and Pharmacokinetics at Rottapharm Biotech

Italy

Dr. Stefano Persiani is currently Director of Translational Sciences and Pharmacokinetics at Rottapharm Biotech, Italy. He graduated in Pharmacy at the University of Milan, Italy and completed a Post-Doctoral fellowship in the Department of Pathology of the University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA, and later as a Research Associate in the Department of Pharmaceutics of the University of Southern California, School of Pharmacy in Los Angeles, California, USA. After these academic positions, he entered the pharmaceutical industry at Farmitalia Carlo Erba, Pharmacia, Upjohn, and Zambon Group and in the CRO sector as Scientific Director for Clinical Pharmacology

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