The Product Development Process

Developing Solid Oral Dosage Forms

Volumn , Issue , 2009, Pages

  Van Kampen, Lynn ^a  

^a UNIVERSITY OF WISCONSIN   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84882902629     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1016/B978-0-444-53242-8.00036-9     Document Type: Chapter

References (5)

1. Guidance for Industry. (2000). Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), August.
2. Strickley R.G. Review: Solubilizing excipients in oral and injectable formulations. Pharmaceutical Research 2004, 21(2). February.
3. Guidance for Industry. (2005). Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), July.
4. Guidance for Industry. (1995). Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, including Well-Characterized, Therapeutic, Biotechnology-derived Products. CDER and CBER, November.
5. Bains W. Failure rates in drug discovery and development: Will we ever get any better?. Drug Discovery World 2004, Fall.