The role of in vitro-in vivo correlations (IVIVC) to regulatory agencies

Advances in Experimental Medicine and Biology

Volumn 423, Issue , 1997, Pages 261-268

  Malinowski, Henry J ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANALYTIC METHOD; ARTICLE; BIOEQUIVALENCE; CORRELATION FUNCTION; DRUG DOSAGE FORM; DRUG SOLUBILITY; FOOD AND DRUG ADMINISTRATION; IN VITRO STUDY; IN VIVO STUDY; PHARMACEUTICS; PRIORITY JOURNAL; STATISTICAL ANALYSIS;

EID: 0030847133     PISSN: 00652598     EISSN: None     Source Type: Book Series    
DOI: 10.1007/978-1-4684-6036-0_24     Document Type: Article

References (5)

1. Guidelines for Dissolution Testing of Solid Oral Products Final Draft 1995, Pharmacopoeial Forum, 21 (5), 1371-1382, 1995.
2. Guidance for Industry - Extended-Release Solid Oral Dosage Forms: Development, Evaluation and Application of in Vitro/in Vivo Correlations, Final Draft July 1,1996. Food and Drug Administration.
3. New FIP Guideline for Dissolution Testing of Solid Oral Products, Dissolution Technologies 3 (3), 3-6, 1996.
4. Use of Dissolution Tests for Bioequivalence Assessment in Japan, Nobuo Aoyagi, Abstract, FIP Bio International 1996, 132-135.
5. Guideline for Bioequivalence Studies of Generic Drugs, Draft July 1, 1996, Ministry of Health and Welfare, National Institute of Health Sciences, Japan.