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level: ICH Guidelines

Questions and Answers List

Question	Answer
Stability testing of new drug substances and products	Q1A
Stability testing; PHOTOSTABILITY testing of new dug substances and products	Q1B
Stability testing for NEW DOSAGE FORMS	Q1C
BRACKETING AND MATRIXING designs for stability testing of drug substances and products	Q1D
EVALUATION of stability data	Q1E
Stability data package for registration Applications in CLIMATIC ZONES III and IV	Q1F
It defines the stability data package for a new drug substance or drug product that is sufficient for a registration application within the three regions of the EC, Japan, and the United States.	Objectives of the Guideline
-The guideline addresses the information to be submitted in registration applications for new molecular entities and associated drug products.	Scope of the Guideline
The purpose of __ is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a re-test period for the drug substance or a shelf life for the drug product and recommended storage conditions.	stability testing