African Journal of
Pharmacy and Pharmacology

  • Abbreviation: Afr. J. Pharm. Pharmacol.
  • Language: English
  • ISSN: 1996-0816
  • DOI: 10.5897/AJPP
  • Start Year: 2007
  • Published Articles: 2188

Review

Comparative analysis of biopharmaceutic classification system (BCS) based biowaiver protocols to validate equivalence of a multisource product

Farah Khalid
  • Farah Khalid
  • Department of Pharmacy Practice, Faculty of Pharmacy, Dow College of Pharmacy, Dow University of Health Sciences, Karachi, Pakistan
  • Google Scholar
Syed Muhammad Farid Hassan
  • Syed Muhammad Farid Hassan
  • Department of Pharmaceutics, Faculty of Pharmacy and Pharmaceutical Sciences, University of Karachi, Karachi, Pakistan
  • Google Scholar
Madiha Mushtaque
  • Madiha Mushtaque
  • Department of Pharmaceutics, Faculty of Pharmacy and Pharmaceutical Sciences, University of Karachi, Karachi, Pakistan
  • Google Scholar
Rabia Noor
  • Rabia Noor
  • Department of Pharmaceutics, Faculty of Pharmacy and Pharmaceutical Sciences, University of Karachi, Karachi, Pakistan
  • Google Scholar
Sana Ghayas
  • Sana Ghayas
  • Department of Pharmaceutics, Faculty of Pharmacy, Dow College of Pharmacy, Dow University of Health Sciences, Karachi, Pakistan
  • Google Scholar
Iyad Naeem Muhamma
  • Iyad Naeem Muhamma
  • Department of Pharmaceutics, Faculty of Pharmacy and Pharmaceutical Sciences, University of Karachi, Karachi, Pakistan
  • Google Scholar
Fouzia Hassan
  • Fouzia Hassan
  • Department of Pharmaceutics, Faculty of Pharmacy and Pharmaceutical Sciences, University of Karachi, Karachi, Pakistan
  • Google Scholar


  •  Received: 05 March 2020
  •  Accepted: 17 July 2020
  •  Published: 31 August 2020

References

Adkin DA, Davis SS, Sparrow RA, Huckle PD, Phillips AJ, Wilding IR (1995).The effects of pharmaceutical excipients on small intestinal transit. British Journal of Clinical Pharmacology 39(4):381-387.
Crossref

 

Amidon GL, Lennernäs H, Shah VP, Crison JR (1995). A theoretical basis for a biopharmaceutic drug classification: The correlation of in vitro drug product dissolution and in vivo bioavailability. Pharmaceutical Research 12(3):413-420.

 

Anderson NH, Bauer M, Boussac N, Khan-Malek R, Munden P, Sardaro M (1998). An evaluation of fit factors and dissolution efficiency for the comparison of in- vitro dissolution profiles. Journal of Pharmaceutical and Biomedical Analysis 17(4-5): 811-822.
Crossref

 

Arrunátegui LB, Silva-Barcellos NM, Bellavinha KR, Ev L da S, Souza J (2015). Biopharmaceutics classification system: importance and inclusion in biowaiver guidance. The Brazilian Journal of Pharmaceutical Sciences 51(1):143-154.
Crossref

 

August BJ (2000). Intestinal permeation enhancers. Journal of Pharmaceutical Sciences 89(4):429-442.
Crossref

 

Blume HH, Schug BS (1999). The biopharmaceutics classification system (BCS): Class III drugs better candidates for BA/BE waiver? European Journal of Pharmaceutical Sciences 9(2):117-121.
Crossref

 

Bodhe R, Kaur H (2018). In-vitro in vivo dissolution correlation BCS classification. 

 

Camenisch GP (2016). Drug disposition classification systems in discovery and development: A comparative review of the BDDCS, ECCS and ECCCS concepts. Pharmaceutical Research 33(11):2583-2593.
Crossref

 

Charalabidis A, Sfouni M, Bergstrom C, Macheras P (2019). The Biopharmaceutics Classification System (BCS) and the Biopharmaceutics Drug Disposition Classification System (BDDCS): Beyond guidelines. International Journal of Pharmaceutics 566(20):264-281.
Crossref

 

Chen ML, Amidon GL, Benet LZ, Lennernäs H (2011). The YLX, BCS. BDDCS, and regulatory guidances. Pharmaceutical Research 28(7):1774-1778.
Crossref

 

Davit BM, Kanfer I, Tsan YC, Cardot JM (2016). BCS Biowaivers: Similarities and Differences Among EMA, FDA, and WHO Requirements. AAPS Journal. 18(3):612-618.
Crossref

 

Dressman J, Butler J, Hempenstall J, and Reppas C (2001). The BCS: Where do we go from here? Pharmaceutical Technology 25(7):68-77.

 

European Medicines Agency (EMA) (2010). Committee for Medicinal Products for Human Use (CHMP), guideline on the investigation of bioequivalence. 

 

European Medicines Agency (EMA) (2015). Compilation of individual product-specific guidance on demonstration of bioequivalence. 

 

Faassen F, Vromans H (2004). Biowaivers for Oral Immediate-Release Products. Clinical Pharmacokinetics 43(15):1117-1126.
Crossref

 

Food and Drug Administration (FDA) (2010). Guidance for industry, bioequivalence recommendations for specific products.

View

 

Food and Drug Administration (FDA) (2017). Center for Drug Evaluation and Research. Guidance for Industry: Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System.

 

Helmy SA, El Bedaiwy HM (2016). In vitro dissolution similarity as a surrogate for in vivo bioavailability and therapeutic equivalence. Dissolution Technologies 23(3):32-39.
Crossref

 

ICH M9: Biopharmaceutics Classification System-Based Biowaivers (2018).

 

International Pharmaceutical Federation (2015). Biowaiver monographs. 

 

Jarc T, Novak M, Hevir N, Rizner TL, Kreft ME, Kristan K (2019). Demonstrating suitability of the Caco-2 cell model for BCS-based biowaiver according to the recent FDA and ICH harmonised guidelines. The Journal of Pharmacy and Pharmacology 71(8):1231-1242.
Crossref

 

Kanfer I (2015). AAPS open forum report (Proposals for regulatory harmonization of a global BCS framework): Challenges and opportunities. Dissolution Technology 22(2):58-65.
Crossref

 

Khandelwal A, Bahadduri PM, Chang C, Polli JE, Swaan PW, Ekins S (2007). Computational models to assign biopharmaceutics drug disposition classification from molecular structure. Pharmaceutical Research 24(12):2249-2262.
Crossref

 

Koch KM, Parr AF, Tomlinson JJ, Sandefer EP, Digenis GA, Donn KH, Powell JR (1993). Effect of sodium pyrophosphate on ranitidine bioavailability and gastrointestinal transit time. Pharmaceutical Research 10(7):1027-1030.
Crossref

 

Lee VHL (2000). Membrane transporters. European Journal of Pharmaceutical Sciences 11(2):S41-S50.
Crossref

 

Levin M (Ed.) (2001).Drugs and the Pharmaceutical Sciences-Pharmaceutical Process Scale-up. Newyork, CRC Press, Taylor & Francis Group 118:552

 

Liberti L, Breckenridge A, Eichler HG, Peterson R, McAuslane N, Walker S (2010). Expediting patients' access to medicines by improving the predictability of drug development and the regulatory approval process. Clinical Pharmacology and Therapeutics 87(1):27-31.
Crossref

 

Lindenberg M, Kopp S, Dressman JB (2004). Classification of orally administered drugs on the World Health Organization Model list of Essential Medicines according to the biopharmaceutics classification system. European Journal of Pharmaceutics and Biopharmaceutics 58(2):265-78.
Crossref

 

O'Hara T, Dunne A., Butler J, Devane J (1998). A review of methods use to compare dissolution profile data. Pharmaceutical Science and Technology Today 1(5):214-223.
Crossref

 

Ploger GF, Hofsass MA, Dressman JB (2018). Solubility determination of active pharmaceutical ingredients which have been recently added to the list of essential medicines in the context of the biopharmaceutics classification system-biowaiver. Journal of Pharmaceutical Sciences 107(6):1478-1488.
Crossref

 

Polli JE, Ginski MJ (1998). Human drug absorption kinetics and comparison to Caco-2 monolayer permeabilities. Pharmaceutical Research 15(1):47-52.
Crossref

 

Rege BD, Yu LX, Hussain AS and Polli JE (2001). Effect of common excipients on Caco-2 transport of low permeability drugs. Journal of Pharmaceutical Sciences 90(11):1776-1786.
Crossref

 

Rohilla S, Rohilla A, Nanda A (2012). Biowaivers: Criteria and Requirements. International Journal of Pharmaceutical and Biological Archive 3(4):727-731.

 

Shah VP, Amidon GL, Amidon GL, Lennernäs H, Shah VP and Crison JR (2014). A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharmaceutical Research 12:413-420, 1995 - Backstory of BCS. AAPS Journal 16(5):894-898.
Crossref

 

Shargel L, WuPong S, Yu ABC (2005). Applied Biopharmaceutics and Pharmacokinetics, Fifth ed. McGraw-Hill Co.Ins.

 

Sugano K (2016). Theoretical investigation of dissolution test criteria for waiver of clinical bioequivalence study. Journal of Pharmaceutical Sciences 105(6):1947-1951.
Crossref

 

United States Pharmacopoeia, USP 24-NF19 (2001). USP24/NF19-25th EditionUS Pharmacopeia Convention, Inc.

 

Van Oudtshoorn JE, García-Arieta A, Santos GML, Crane C, Rodrigues C, Simon C, Kim JM, Park SA, Okada Y, Kuribayashi R, Pfäffli C, Nolting A, Lojero IOC, Martínez ZR, Hung WY, Braddy AC, Leal NA, Triana DG, Clarke M, Bachmann P (2018). A Survey of the Regulatory Requirements for BCS-Based Biowaivers for Solid Oral Dosage Forms by Participating Regulators and Organisations of the International Generic Drug Regulators Programme. The Journal of Pharmacy and Pharmaceutical Sciences 21(1):27-37.
Crossref

 

Verbeeck RK, Musuamba FT (2012). The revised EMA guideline for the investigation of bioequivalence for immediate release oral formulations with systemic action. The Journal of Pharmacy and Pharmaceutical Sciences 15(3):376-88.
Crossref

 

Wacher VJ, Salphati L, Benet LZ (2001). Active secretion and enterocytic drug metabolism barriers to drug absorption. Advanced Drug Delivery Reviews 46(1-3):89-102.
Crossref

 

World Health Organization (2006). Expert Committee on Specifications for Pharmaceutical Preparations. Proposal to waive in-vivo bioequivalence requirements for WHO Model list of essential medicines immediate-release, solid oral dosage forms. WHO Technical report series, No.937, Annex 8.

 

World Health Organization (2015). WHO technical report series, No. 992 annex 7. Multisource (Generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability.

 

WHO biowaiver list based on the WHO model list of essential medicines (2018). 

View

 

Wu CY, Benet LZ (2005). Predicting drug disposition via application of BCS: transport/absorption/ elimination interplay and development of a biopharmaceutics drug disposition classification system. Pharmaceutical Research 22(1):11-23.
Crossref

 

Yu L, Bridgers A, Polli J, Vickers A, Long S, Roy A, Winnike R, Coffin M (1999).Vitamin E-TPGS increases absorption flux of an HIV protease inhibitor by enhancing its solubility and permeability. Pharmaceutical Research 16(12):1812-1817.
Crossref

 

Yu LX, Amidon GL, Polli JE, Zhao H, Mehta MU, Conner DP, Shah VP, Lesko LJ, Chen ML, Lee VHL, and Hussain AS (2002). biopharmaceutical classification: The scientific basis for biowaiver extension. Pharmaceutical Research 19(7): 921-925.
Crossref