Juhyun Kim, PhD

Senior Pharmacologist
US Food and Drug Administration

Poster(s):

• (T0930-10-56) Current Drug Substance Stability Issues Related to the Biopharmaceutics Classification System (BCS) Class III -Based Biowaivers in Abbreviated New Drug Applications (ANDAs)
  Tuesday, October 22, 2024

  9:30 AM – 10:30 AM MT

• (T1430-02-09) Evaluation of Methods for Assessing Pre-Dose Steady-State Drug Concentration Attainment in Bioequivalence Studies in Abbreviated New Drug Application (ANDA) Submissions
  Tuesday, October 22, 2024

  2:30 PM – 3:30 PM MT

• (M1430-02-11) Common Bioequivalence (BE) Deficiencies Identified in ANDAs Associated with Solid Oral Extended-Release Drugs in Various Therapeutic Areas: A Retrospective Survey of BE Study Data Submitted to the FDA
  Monday, October 21, 2024

  2:30 PM – 3:30 PM MT