Title 12. ABBREVIATED NEW DRUG APPLICATION.pdf ✅

PHARMD GURU Page 3  Number & frequency of Blood & Urine collection.  The methodology of the assay. SAMPLES:  Sample of drug substances & finished products.  Should be provided in 4 individual units, in sufficient quantities to FDA.  Permits FDA to perform all tests (at least thrice). ANALYTICAL METHODS FOR DRUG SUBSTANCE AND DRUG PRODUCT:  Specifications.  Analytical methods.  Validation methods.  Stability tests.  Manufacturing details. CASE REPORT FORMS AND TABULATIONS: Should be discussed with bioequivalence personnel, prior to ANDA Submission.