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Biowaiver: an alternative to in vivo pharmacokinetic bioequivalence studies.
Pharmazie. 2010 Mar; 65(3):155-61.P

Abstract

Bioequivalence is a vital concern in drug development even more significant in the case of Narrow Therapeutic Index (NTI) drugs. In clinical development of New Chemical Entities (NCE), bioequivalence studies necessitate to be performed when the formulation of the pharmaceutical dosage form has been changed. In vivo pharmacokinetic data can be used as surrogate parameters for in vivo solubility and permeability data. The Biopharmaceutics Classification System (BCS) has emerged as a helpful tool in product development by alluding to the in vivo performance of the active substance. The bio-relevance of the BCS properties and the in vitro release are best expressed through a correlation between in vitro and in vivo data. Recently BCS has been implemented for waiving bioequivalence studies on the basis of the solubility and gastrointestinal permeability of drug substance and can be strategically deployed to save time and resources during generic drug development. The BCS has been adopted as a very useful tool for in vivo drug design and development worldwide, particularly in terms of regulatory standards. A BCS-based biowaiver has become an important and cost-saving tool in approval of generic drugs.

Authors+Show Affiliations

Pharmaceutics Research Laboratory, Department of Pharmaceutical Sciences, Dr. H. S. Gour University, Sagar (M.P.), India.No affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

20383933

Citation

Mishra, V, et al. "Biowaiver: an Alternative to in Vivo Pharmacokinetic Bioequivalence Studies." Die Pharmazie, vol. 65, no. 3, 2010, pp. 155-61.
Mishra V, Gupta U, Jain NK. Biowaiver: an alternative to in vivo pharmacokinetic bioequivalence studies. Pharmazie. 2010;65(3):155-61.
Mishra, V., Gupta, U., & Jain, N. K. (2010). Biowaiver: an alternative to in vivo pharmacokinetic bioequivalence studies. Die Pharmazie, 65(3), 155-61.
Mishra V, Gupta U, Jain NK. Biowaiver: an Alternative to in Vivo Pharmacokinetic Bioequivalence Studies. Pharmazie. 2010;65(3):155-61. PubMed PMID: 20383933.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Biowaiver: an alternative to in vivo pharmacokinetic bioequivalence studies. AU - Mishra,V, AU - Gupta,U, AU - Jain,N K, PY - 2010/4/14/entrez PY - 2010/4/14/pubmed PY - 2010/5/21/medline SP - 155 EP - 61 JF - Die Pharmazie JO - Pharmazie VL - 65 IS - 3 N2 - Bioequivalence is a vital concern in drug development even more significant in the case of Narrow Therapeutic Index (NTI) drugs. In clinical development of New Chemical Entities (NCE), bioequivalence studies necessitate to be performed when the formulation of the pharmaceutical dosage form has been changed. In vivo pharmacokinetic data can be used as surrogate parameters for in vivo solubility and permeability data. The Biopharmaceutics Classification System (BCS) has emerged as a helpful tool in product development by alluding to the in vivo performance of the active substance. The bio-relevance of the BCS properties and the in vitro release are best expressed through a correlation between in vitro and in vivo data. Recently BCS has been implemented for waiving bioequivalence studies on the basis of the solubility and gastrointestinal permeability of drug substance and can be strategically deployed to save time and resources during generic drug development. The BCS has been adopted as a very useful tool for in vivo drug design and development worldwide, particularly in terms of regulatory standards. A BCS-based biowaiver has become an important and cost-saving tool in approval of generic drugs. SN - 0031-7144 UR - https://www.unboundmedicine.com/medline/citation/20383933/Biowaiver:_an_alternative_to_in_vivo_pharmacokinetic_bioequivalence_studies_ L2 - https://medlineplus.gov/medicines.html DB - PRIME DP - Unbound Medicine ER -