Answer 1:答 1According to the FDA guidance for industry ANDAs:Stability Testing of Drug Substances and Products Questions and Answers (May2014), “For primary batches of liquids, solutions, semi-solids, andsuspensions, the product should be placed into an inverted (or horizontal)position and an ...
and Research (CDER) December 2012 Procedural TABLE OF CONTENTS I. INTRODUCTION1 II. BACKGROUND 1 III. QUESTIONS AND ANSWERS 2 A. GENERAL QUESTIONS 2 1. Application Submission 2 2. INDs 7 3. ANDAs 10 B. CHEMISTRY, MANUFACTURING, AND CONTROLS 17 1. General17 2. Stability Testing 22 3. ...
Doall of these exhibit batches need to be put into the stability program? 采用同一制粒工艺(或混合)得到的物料生产多个剂量规格仿制药展示批次时,是否可以使用分组法?是不是需要把所有这些展示批都放入稳定性试验计划? Answer: 答 A bracketing approach is acceptable for adrug product with multiple strength...
Legitimacy of FDA Guidances Called into Questiondoi:10.1089/blr.2012.9907.Biotechnology Law Report
Yes. Can this question be answered by reference to a DMF? The ANDA should include a list of potential impurities and their origins. The methods used to identify and characterize these impurities can be incorporated by reference to the DMF. 8 According to the CTD guidance, section S.3 should...
and right numbers of control measurements, i.e., the right QC procedure, which should be used whenever the stability of the measurement procedure is to be tested. Information from a manufacturer’s risk assessment studies could then provide guidance for “whenever” external QC should be ...
Question: I have a dietary supplement, cosmetic, or medical device that I want to bring to market. What kind of legal issues are involved, what are my risks vis-à-vis the federal Food and Drug Administration (FDA) and FDA law, and what will it cost for advice? Answer: Seeking legal...
These market players have undertaken various business strategies to enhance their financial stability and help them evolve as leading companies in the direct-to-consumer genetic testing industry. For example, in November 2018, Helix launched a new genetic testing product, DNA discovery kit, that ...
system. He could not answer the question. Then, both the President of Technical Operations and the Managing Director asked him the same question in a different way and local language. Still, he could not answer the question. We asked him to show us how ...
Feel free to leave a comment. If you have a question I will try to give an answer or ask someone who can. Best regards and good luck to all of you. 23 July 2012 –Carl Anderson,GxP Perspectives You can still join theGxP Perspectives Linkedin Group ...