Handbook of pharmaceutical manufacturing formulations: Uncompressed solid products volume 2

Handbook of Pharmaceutical Manufacturing Formulations: Uncompressed Solid Products Volume 2

Volumn , Issue , 2004, Pages 1-205

  Niazi, Sarfaraz K ^a  

^a Pharmaceutical Scientist Inc   (United States)

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[No Author keywords available]

Indexed keywords

EID: 73449097695     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Book

References (6)

1. This guidance has been prepared by the Biopharmaceutics Classification System Working Group of the Biopharmaceutics Coordinating Committee in the Center for Drug Evaluation and Research (CDER) at the FDA (http://www.fda.gov/cder/guidance/P103_1926#P103 1926). This guidance represents the Agency’s current thinking on the topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such an approach satisfies the requirements of the applicable statutes, regulations, or both.
2. Amidon, G. L., H. Lennernäs, V. P. Shah, and J. R. Crison, A Theoretical Basis for a Biopharmaceutics Drug Classification: The Correlation of in vitro Drug Product Dissolution and in vivo Bioavailability, Pharmaceutical Research, 12: 413–420 (1995).
3. FDA guidance for industry on Submitting Documentation for the Stability of Human Drugs and Biologics (February 1987), posted at http://www.fda.gov/guidance/index.htm or http://www.fda.gov/cder/guidance/P147_9605#P147_9605.
4. FDA guidance for industry on Dissolution Testing of Immediate Release Solid Oral Dosage Forms (August 1997), http://www.fda.gov/cder/guidance/P192_20128#P192_20128.
5. This guidance uses the term narrow therapeutic range instead of narrow therapeutic index, although the latter is more commonly used, http://www.fda.gov/cder/guidance/P223_24902#P223_24902.
6. FDA guidance for industry on Immediate Release Solid Oral Dosage Forms: Scale-Up and PostApproval Changes (November 1995), http://www.fda.gov/cder/guidance/P239_26746#P239_26746.