Pharmacokinetic-Pharmacodynamic (PK/PD) Modeling (5-day) Training
Closed Solicitation Posted
- Solicitation number
- 75F40124R00072
- Agency
-
FDA Office of Acquisition and Grant Services
Food and Drug Administration, Department of Health and Human Services
- Responses due
- Set-aside
- Total Small Business
Opportunity facts
- NAICS code
- 541690 Other Scientific and Technical Consulting Services
- PSC
- U099 Education/Training- Other
- Place of performance
- United States
Notice details come from SAM.gov. Updated .
About this opportunity
Paragraph 1:
The Department of Health and Human Services (HHS) Food and Drug Administration (FDA) Office of Acquisition and Grant Services is seeking to procure a 5-day training course on Pharmacokinetic-Pharmacodynamic (PK/PD) Modeling. The purpose is to increase the knowledge, skills, and abilities of FDA's Office of Bioequivalence (OB) scientists and technical staff in applying quantitative modeling approaches to support the approval of generic drug products. Key topics include using modeling to reduce/replace in vivo bioequivalence studies, ensure consistency of bioequivalence recommendations, evaluate complex and narrow therapeutic index products, and determine appropriate study designs. Proposals will be evaluated based on technical capability, price, and past performance, with price being the most important factor.
Paragraph 2:
This requirement is set aside for small businesses. The period of performance is from May 7, 2024 to July 31, 2024, and the training is expected to be provided for up to 50 OB staff members. The solicitation also includes a separate 2-3 day training on Quantitative Modeling and Simulation Approaches for Application in the Development and Approval of Generic Drug Products. The North American Industry Classification System (NAICS) code is 541690 - Other Scientific and Technical Consulting Services, and the Product Service Code (PSC) is U099 - Education/Training- Other.
Notice text
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 BE evaluation.
- PK/PD modeling and simulation to determine the appropriate study design and evaluate sensitivity for BE assessment.
Files
| File | Type | Posted |
|---|---|---|
| 75F40124R00072_Revised_8-16-2024.docx | DOCX document | |
| 75F40124R00072.docx | DOCX document |
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