Abstrak :
This Book is About Regulatory and Manufacturing Guidance1 : Changes to Approved New Drug Applications or Abbreviated New Drug Applications, Postapproval Changes to Semisolid Drugs, Scale-Up and Postapproval Changes for Nonsterile Semisolid Dosage Forms: Manufacturing Equipmen, Stability Testing of Drug Substances and Drug Products, Guidelines for Evaluation of Stability Data in Retest Periods, Skin Irritation and Sensitization Testing of Generic Transdermal Drug Products, Photosafety Testing, Guidance on Formulating Semisolid Drugs. Formulations of Semisolid Drugs.2