Regulatory Science (RS)

P-001 - A RETROSPECTIVE ANALYSIS OF PHARMACOKINETIC VARIABILITY BETWEEN FASTING AND FASTING SPRINKLE BIOEQUIVALENCE STUDIES OF GENERIC MODIFIED-RELEASE DRUG PRODUCTS: A CASE STUDY ON ESOMEPRAZOLE MAGNESIUM.

P-058 - PREPARATION AND CHARACTERIZATION OF PHYSICALLY MANIPULATED ABUSE-DETERRENT FORMULATION OF AN OPIOID PRODUCT PREPARED FOR NASAL INSUFFLATION STUDY.

P-077 - QT PROLONGATION RISK ASSESSMENT IN NON-ADC MONOCLONAL ANTIBODIES: A COMPREHENSIVE REVIEW OF FDA APPROVED IMMUNOLOGY, NEUROSCIENCE AND ONCOLOGY PRODUCTS BETWEEN 2015 AND 2020.

P-108 - EVALUATION OF GASTRIC pH-DEPENDENT DRUG INTERACTIONS WITH ACID-REDUCING AGENTS FOR ORALLY ADMINISTERED ONCOLOGY DRUGS - CURRENT STATUS AND FURTHER ASSESSMENTS.

P-159 - QUANTITATIVE DISCRIMINATION OF CUTANEOUS PHARMACOKINETIC PROFILES FOR TOPICAL DRUG PRODUCTS.

P-190 - IMPROVED GSimp - A FLEXIBLE MISSING VALUE IMPUTATION METHOD TO SUPPORT GENERIC DRUG DEVELOPMENT AND REGULATORY ASSESSMENT.

P-202 - RESEARCH FOR THE EFFICIENT ASSESSMENTS OF THE NONCLINICAL EFFICACY OF ORPHAN DRUGS: IN SOME ANTICANCER DRUGS WITH SPECIFIC MUTATION OR RESISTANCE AND IN SOME NON-ANTICANCER DRUGS WITHOUT ANIMAL MODELS.

PT-017 - CLINICAL PHARMACOLOGY POSTMARKETING STUDIES: A US FDA EVALUATION OF KNOWLEDGE GAPS AND TRANSLATION INTO LABELING.

PT-017 - CLINICAL PHARMACOLOGY POSTMARKETING STUDIES: A US FDA EVALUATION OF KNOWLEDGE GAPS AND TRANSLATION INTO LABELING.

LB-012 - EVALUATION OF GLUCOSE ADMINISTRATION RECOMMENDATION IN BIOEQUIVALENCE STUDIES TO SUPPORT GENERIC ORAL ANTIDIABETIC DRUG DEVELOPMENT.