Pharmacokinetic-Pharmacodynamic (PK/PD) Modeling (5-day) Training Tender, USA - 105947674

Procurement Summary

Country : USA

Summary : Pharmacokinetic-Pharmacodynamic (PK/PD) Modeling (5-day) Training

Deadline : 23 Aug 2024

Other Information

Notice Type : Tender

TOT Ref.No.: 105947674

Document Ref. No. : 75F40124R00072

Competition : ICB

Financier : Self Financed

Purchaser Ownership : Public

Tender Value : Refer Document

Purchaser's Detail

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Tender Details

Description

The purpose of this requirement is to increase OB scientist and technical staff-s knowledge, skills, and abilities to perform their duties in working at the drug discovery interface responsible for lead optimization and candidate selection thereby aiding OB in serving FDA-s mission. Current approaches in the field of Pharmacokinetic-Pharmacodynamic involve development of models based on mechanisms of drug action and their alteration of physiologic processes. This course will provide a comprehensive overview of the principles, techniques, and applications of PK/PD modeling with a partial emphasis on modeling for bioequivalence (BE) assessment. Such modeling allows the optimal design and interpretation of pharmacologic experiments that range from molecular biology to human responses and can expedite the drug development process. Lectures and examples from the literature will be provided with course notes for all participants. Selected models or examples will include computer code to show how to quantitate typical experimental data. At the conclusion of this course, the biomedical scientist with basic knowledge in pharmacokinetic will be able to understand the diverse array of available PK/PD models and begin to apply them to experimental data and simulate anticipated drug responses.

Specific topics that will be considered in this training include the following:

Modeling and simulation of modified release solid oral products to ensure the consistency and quality of BE recommendations. Modeling and simulation to reduce/replace in vivo BE studies (i.e. in vivo PK BE studies, clinical endpoint or pharmacodynamic endpoint BE studies) for complex generic products and other generic products with clinical study challenges including long acting injectable and implantable products, oncology drug products, and orphan drug products. PK/PD modeling of narrow therapeutic index drugs and complex drug products and clinical trial simulations to aid risk-based ...
Active Contract Opportunity
Notice ID : 75F40124R00072
Related Notice
Department/Ind. Agency : HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Sub-tier : FOOD AND DRUG ADMINISTRATION
Office: FDA OFFICE OF ACQ GRANT SVCS
General Information
Contract Opportunity Type: Combined Synopsis/Solicitation (Updated)
All Dates/Times are: (UTC-04:00) EASTERN STANDARD TIME, NEW YORK, USA
Updated Published Date: Aug 16, 2024 12:03 pm EDT
Original Published Date: Apr 16, 2024 03:41 pm EDT
Updated Date Offers Due: Aug 23, 2024 10:00 am EDT
Original Date Offers Due: May 02, 2024 10:00 am EDT
Inactive Policy: 15 days after date offers due
Updated Inactive Date: Sep 07, 2024
Original Inactive Date: May 17, 2024
Initiative: None

Classification
Original Set Aside: Total Small Business Set-Aside (FAR 19.5)

Product Service Code: U099 - EDUCATION/TRAINING- OTHER
NAICS Code: 541690 - Other Scientific and Technical Consulting Services

Place of Performance: USA

Documents

 Tender Notice

75F40124R00072_Revised_8-16-2024.docx

75F40124R00072.docx