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Assessment of Manufacturing Related Deficiencies for Modified Release Tablet in Abbreviated New Drug Applications

Journal Article · · AAPS PharmSciTech
Not provided.
Research Organization:
Oak Ridge Institute for Science and Education (ORISE), Oak Ridge, TN (United States)
Sponsoring Organization:
USDOE Office of Science (SC)
DOE Contract Number:
SC0014664
OSTI ID:
1983045
Journal Information:
AAPS PharmSciTech, Journal Name: AAPS PharmSciTech Journal Issue: 7 Vol. 23; ISSN 1530-9932
Publisher:
Springer
Country of Publication:
United States
Language:
English

References (3)

Understanding Pharmaceutical Quality by Design journal May 2014
Assessment of Applications of Design of Experiments in Pharmaceutical Development for Oral Solid Dosage Forms journal July 2019
Challenges and Opportunities in Establishing Scientific and Regulatory Standards for Assuring Therapeutic Equivalence of Modified Release Products: Workshop Summary Report journal May 2010

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