Siladitya Behera
Author Profile
Regulatory Affairs Department, Sun Pharmaceutical Advanced Research Company Limited, Tandalja, Vadodara-390 020, Gujarat, India
1
Publications
1
Years Active
0
Collaborators
51
Citations
Publications by Siladitya Behera
1 publication found • Active 2013-2013
2013
1 publicationSignificance of Impurities in Drug Substance and Product and Role of Analytical Methods
2/1/2013
The current practice of characterization and control of impurities in pharmaceuticals is reviewed with emphasis on issues specific to the generic industry. This review includes an overview of FDA, ICH, TGA, TPD and EMEA guidelines related to impurities in Drug Substance and Drug Products. This introduces the identification, characterization and qualification procedures for ANDAs and approaches to the establishment of acceptance criteria for both drug substance and drug product and significance of analytical methods in total process.
Author Statistics
Total Publications:1
Years Active:1
First Publication:2013
Latest Publication:2013
Collaborators:0
Citations:51
Research Topics