Regulatory Science (RS)

PII-186 - A SURVEY ON RECOMMENDATION OF FOOD CONDITIONS IN BIOEQUIVALENCE STUDIES WITH PHARMACOKINETIC ENDPOINTS FOR GENERIC ORAL ANTINEOPLASTIC DRUG DEVELOPMENT.

PII-187 - ASSESSMENT OF MALE INFERTILITY RISKS TO SUPPORT PRODUCT-SPECIFIC GUIDANCE DEVELOPMENT FOR GENERIC ORAL PRODUCTS.

PII-188 - DEEP DIVE INTO GENERIC DRUG APPLICATIONS TO SEEK DATA-DRIVEN HARMONIZATION OF BIOEQUIVALENCE CRITERIA FOR NARROW THERAPEUTIC INDEX DRUGS.

PII-189 - EVALUATION OF CARDIOVASCULAR TOXICITY PROFILE OF ALK INHIBITORS USING ADVERSE EVENT REPORTING DATABASE

PII-190 - GLOBAL HARMONIZATION OF IMMEDIATE-RELEASE SOLID ORAL DRUG PRODUCT BIOEQUIVALENCE RECOMMENDATIONS AND THE IMPACT ON GENERIC DRUG DEVELOPMENT.

PII-191 - PEDIATRIC CLINICAL TRIAL DESIGNS FOR TESTOSTERONE REPLACEMENT THERAPY.

PII-192 - SAFETY CONSIDERATIONS OF SUBJECT POPULATION SELECTION IN BIOEQUIVALENCE STUDIES FOR GENERIC DRUG DEVELOPMENT.