标明替代给药方案的药品的一般质量考虑-Kona.pdf

1、General Quality Considerations of Drug Products Labeled for Alternate Dosing AdministrationRavikanth Kona,PhDPharmaceutical ScientistOffice of Pharmaceutical QualityCenter for Drug Evaluation and ResearchU.S.Food and Drug AdministrationGeneric Drug Forum April 10,2025fda.gov/cdersbiafda.gov/cdersbia

2、2Learning Objectives Understand general quality considerations of Drug Products Labeled for Alternate Dosing Administration Identify relevant FDA Guidances along with general quality information for generic drug applications.Learn effective data submission for Products Labeled for Alternate Dosing A

3、dministration.fda.gov/cdersbiafda.gov/cdersbia3Outline Products labeled for alternate administration Quality information Case studies Challenge questionsfda.gov/cdersbiafda.gov/cdersbia4Alternate Dosing AdministrationAlternate dosing administration refers to the method of delivering a drug or medica

4、tion through a different route other than the standard or conventional one,in order to achieve the desired therapeutic effect.Types of alternate dosing administration:Use of Soft food or liquid as vehicle Enteral Feeding tube Admixtures fda.gov/cdersbiafda.gov/cdersbia5Use of Liquids and/or Soft Foo

5、ds as Vehicles Many commercial drug product dosage forms such as granules,pellets,powders,or tablets have drug product labeling which includes instructions for the optional use of soft foods or liquids as vehicles for their administration.Footnote 4Source:Draft Guidance for Industry Use of Liquids a

6、nd/or Soft Foods as Vehicles for Drug Administration:General Considerations for Selection and In Vitro Methods for Product Quality Assessments(July 2018).fda.gov/cdersbiafda.gov/cdersbia6General Consideration for selection of Vehicle Compatibility and Suitability Impact of Vehicle on the drug produc