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Ref : 31923
Event :Preclinical Development of Drugs with Special Emphasis on Biologicals

Date :Wednesday July 08th, 2020

Location :2479 E. Bayshore Road Suite 260
Palo Alto, United States

Type :Conference & Seminar - International audience

Accreditation :--


 

Further information

Editorial

Preclinical development is a critical stage of drug development that determines as well as measures the “therapeutic” doses needed and the ability to achieve these doses. Moreover, preclinical studies assess the safety of the drug at these doses.
 

Objectives

  • Reference documents
  • Rule documents or guidance
  • Checklist
  • SOP template
  • Easy fill in forms
  • Articles


 

Program

To successfully develop a therapeutic drug one needs to understand, in addition to the choice of target and indication and the segment of patients to treat. One needs to understand what the drug does to the patient (toxicological) and what the patient would do to the drug (metabolism and clearance). Preclinical development, utilizing relevant animal models, attempts to clear the later points.

In this webinar, we will discuss strategies needed to successfully develop a drug followed by a brief discussion of the stages of drug development and the functional groups associated with each of the three stages. We will demonstrate that preclinical development is a stage that spans the entire drug development phase.

Preclinical development activities start at discovery to help candidate selection, determining the safety of the drug and determining the therapeutic doses as well as calculates the first in human dose. Preclinical and nonclinical activities do not end when the drug enters clinical studies but continues until marketing or even after that.

Speakers

cientist with more than 20 years of experience in small biotechnology and large pharmaceutical companies. Developed protein-based (peptides, mAb, ADC, bispecific antibodies), small molecules and liposomal products. Carried these products from inception through preclinical development into early clinical development. Developed products for the treatment and diagnosis of cancer, for the treatment of immunological diseases, including those that can facilitate transplantation of solid organs, and for neurological dieses (Alzheimer’s). Directed the safety as well as bioanalytical studies (PK and Immunogenicity) of many of the products in the preclinical setting. wrote Preclinical sections of regulatory submissions.
 

Organizing committee

Complianceonline
 

Location

Map and directions
Conference address :
2479 E. Bayshore Road Suite 260
Palo Alto
United States
Map and directions

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Details

Preclinical Development of Drugs with Special Emphasis on Biologicals Pharmacy
preclinical development, preclinical drug development, preclinical drug development course, preclinical drug development training, preclinical training, preclinical drug development stages, preclinical drug development strategy, preclinical drug development process
Professionals
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