dissolution media / water soluble drug product / water soluble products / manufacturing variables / generic drug product / acceptable and unacceptable drug products / water soluble drug products / drug product / quality control tool / generic product / postapproval manufacturing changes / abbreviated new drug applications / combination product / manufacturing technology / release drug products / reference products / manufacturing / generic drug applications / release products / unacceptable products / drug products / generic products / Acceptable products / manufacturing process / /
Organization
U.S. Department of Health and Human Services / Food and Drug Administration Center for Drug Evaluation and Research / Food and Drug Administration / Biopharmaceutics Coordinating Committee / Division of Bioequivalence / office of Training / office of Pharmaceutical Science / Training and Communications Division / U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research / office of Generic Drugs / / /
Product
carbamazepine / Reference Listed / Solid Oral / New Drug Substances / /
Technology
pharmacokinetics / drug delivery / drug development / /
Guidance for Industry Dissolution Testing of Immediate Release Solid Oral Dosage Forms U.S. Department of Health and Human Services Food and Drug Administration