Author(s): Sunil Kumar, Dilip Maheshwari


DOI: 10.52711/0974-360X.2024.00224   

Address: Sunil Kumar, Dilip Maheshwari
Department of Pharmaceutical Sciences, Lok Jagruti Kendra University, Ahmedabad, Gujarat, India.
*Corresponding Author

Published In:   Volume - 17,      Issue - 3,     Year - 2024

Biowaiver refers to the waiving of bioequivalence studies or in vivo bioavailability. The model-independent similarity factor approach for the dissolution profiling test is considered in the comparison shown in this article survey. Rather than conducting costly and tedious bioequivalence (in vivo) examinations, a dissolution test can be used as an alternative for comparing whether two drug products are identical or not. The purpose of this review is to feature the expectations of various regulatory bodies for biowaiver studies. Initially, no regulatory agency defined the early time point; however, the FDA recently defined the early time point as up to 10 minutes for products with a fast or immediate release rate. The biowaiver approach based on the BCS (Biopharmaceutical Classification System) is intended to reduce the requirement for studies of bioequivalence, so it can provide an alternative to bioequivalence studies. Bioequivalence studies might be waived if in vivo execution can be legitimated by satisfactory dissolution profiling information. The Biopharmaceutical Classification System approach is logical in view of the gastrointestinal permeability, aqueous solubility, and characteristics of the drug molecules. The model-independent similarity factor (f2) method is suggested by numerous regulatory bodies to show dissolution closeness or similarity worldwide. This f2 method is leaned toward on the grounds that it is generally simple to utilize, the similarity factor (f2) value is not difficult to calculate, and a well-known acceptance criteria for profile closeness or f2 (similarity) (i.e., f2=50) has been set. As per comparison with different regulatory guidelines for dissolution profiling, it was found that there were many divergences in the criteria for exemption from the F2 criteria, the selection of the minimum number of dissolution profile time points, the selection of end time points, and the coefficient of variation. So it is needed to harmonies a guideline on biowaiver studies that can be applicable to all countries for ANDA (Abbreviated New Drug Application) filing purposes.

Cite this article:
Sunil Kumar, Dilip Maheshwari. Selection of different factors for the Calculation of Similarity factor (f2) and Dissimilarity factor (f1) as per different countries' regulatory recommendations for the biowaiver Study: A Systematic Review. Research Journal of Pharmacy and Technology. 2024; 17(3):1414-7. doi: 10.52711/0974-360X.2024.00224

Sunil Kumar, Dilip Maheshwari. Selection of different factors for the Calculation of Similarity factor (f2) and Dissimilarity factor (f1) as per different countries' regulatory recommendations for the biowaiver Study: A Systematic Review. Research Journal of Pharmacy and Technology. 2024; 17(3):1414-7. doi: 10.52711/0974-360X.2024.00224   Available on:

1.    FDA Guidance for Industry. SUPAC-IR. Immediate release solid oral dosage forms. Scale-up and post approval changes. Chemistry, manufacturing and controls. In vitro dissolution testing and in vivo bioequivalence documentation. 1995.
2.    Dorys Argelia Diaz et al, Dissolution Similarity Requirements: How Similar or Dissimilar Are the Global Regulatory Expectations? The AAPS Journal, Vol. 18, No. 1, January 2016 (© 2015)
3.    M9, Biopharmaceutics Classification System-Based Biowaivers, Guidance for Industry, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER),May 2021, ICH
4.    Pinaz A. Kasad, K.S. Muralikrishna. Design and Validation of Dissolution Profile of Rivaroxaban by Using RP-HPLC Method in Dosage Form. Asian J. Pharm. Ana. 3(3): July-Sept. 2013; Page 75-78.
5.    Dr. Mazen Kurdi, Dr. Rita Karam, Biowaivers: Criteria and Requirements, Biowaivers: Criteria and Requirements – MOPH –2015
6.    Kassaye L, Genete G, Evaluation and comparison of in-vitro dissolution profiles for different brands of amoxicillin capsules, African Health Sciences Vol 13 Issue 2 June 2013,369-375
7.    Nair AK. Statistics on BCS Classification of Generic Drug Products Approved Between 2000 and 2011 in the USA. AAPS Journal. 2012 June; 14: p. 664-6.
8.    Snehal S Manekar, Ravindra L. Bakal, Manoj S. Charde. Enhancement of Dissolution profile of poorly water soluble drug using Water Soluble Carriers. Asian Journal of Pharmaceutical Research. 2022; 12(2):137-2.
9.    Patel Jimi et al, Comparison of global regulatory guidelines for availability of different biowaiver provisions and application requirements of biopharmaceutics classification system (bcs) based biowaiver, International Journal of Drug Regulatory Affairs; 2015, 3(3), 8-20
10.    Sathe P, Tsong Y, Shah P. In vitro dissolution profile comparison:statistics and analysis, model dependent approach. Pharm Res. 1996;13(12):1799–803.
11.    Pankaj P. Ostwal, Yogesh L. Jadhav, Mayur S. Jain, Sumit P. Jain. Dissolution Profiling of Bilayered Conventional Release Paracetamol and Sustained Release Ibuprofen (By Simultaneous Estimation Method UV). Research J. Pharm. and Tech. 5(4): April 2012; Page 490-493.                                  
12.    Shah V, Tsong Y, Sathe P, Liu J. In vitro dissolution profile comparison—statistics and analysis of the similarity factor, f2. Pharm Res. 1998;15(6):889–96.
13.    Department of Health, Therapeutic Goods Administration, Australia. Minor variations to registered prescription medicines: Chemical Entities. Version1.2. 2013 May.
14.    Swati Saxena, Sarang Jain. A Review on Biopharmaceutical Classification System. Asian J. Pharm. Tech. 2019; 9 (4):267-270.
15.    FDA Guidance For Industry. Bioavailability and bioequivalence studies for orally administered drug products, general considerations.2003
16.    S. Poongothai, C.M. Karrunakaran, R. Ilavarasan. Development and Validation of a Discriminating Method of Dissolution for Ropinirole Tablets Based on In Vivo Data. Research J. Pharm. and Tech. 7(11): Nov. 2014 Page 1285-1291.
17.    Vinutha Kommineni, K.P.R. Chowdary, S.V.U.M. Prasad. Formulation of Dapagliflozin and Saxagliptin Tablets and In vitro Evaluation by RP-HPLC Method. Asian J. Pharm. Ana. 2019; 9(2):93-98.
18.    Ashok B. Patel, Avadhi R. Bundheliya, Rushali V. Zala, Amitkumar J. Vyas, Nilesh K. Patel, Ajay I. Patel, Devang B. Sheth. A Brief Review on Dissolution Method Development. Asian Journal of Pharmaceutical Analysis. 2022; 12(2):127-4.
19.    Moore J, Flanner H. Mathematical comparison of dissolution profiles. Pharm Technol. 1996;20(6):64–74.
21.    Vipul V. Jambukiya, Ramesh B. Parmar, Ashvin V. Dudhrejiya, H. M. Tank, Vipul D. Limbachiya . Enhancement of Solubility and Dissolution Rate of Poorly Water Soluble Drug by Using Modified Guar Gum. Asian J. Res. Pharm. Sci. 3(1): Jan.-Mar. 2013; Page 25-30.
22.    Priyanka M. Salve, Shital V. Sonawane, Mayuri B. Patil, Rajendra K. Surawase. Dissolution and Dissolution Test Apparatus: A Review. Asian Journal of Research in Pharmaceutical Sciences. 2021; 11(3):229-6.
23.    Girishchandra R., Mandake, Shital S. Shinde, Vishal Y. Belaskar, Asha M. Jagtap, Ganesh B. Vambhurkar, Manoj M. Nitalikar. Modification of Dissolution Profile of Rivaroxaban by spray Drying .Asian J. Pharm. Tech. 2018; 8 (4):203-210.
24.    Mohamed Rizwan I, Damodharan N. Mathematical Modelling of Dissolution Kinetics in Dosage forms. Research J. Pharm. and Tech 2020; 13(3):1339-1345. doi: 10.5958/0974-360X.2020.00247.4
25.    Xie F, Ji S, Cheng Z. In vitro dissolution similarity factor (f2) and in vivo bioequivalence criteria, how and when do they match? using a BCS class II drug as a simulation example. Eur J Pharm Sci. 2015;66:163–72.
27.    Rahul Rajge, Vishal Mahanur, Mukund Tawar. Effect on Drug Release profile of Meclizine Hydrochloride by using various Dissolution Media. Asian Journal of Pharmacy and Technology. 2021; 11(3):191-7.
28.    Health Canada. Drugs and Health Products. Post-Notice of Compliance (NOC) Changes: Quality document. 2013; File Number 13-107786-650.
29.    Amit Kaushal, Sandeep Arora, Sukhbir Singh, Neelam Sharma. Assessing the Impact of Formulation Variables on Dissolution Profile of Sustained Release Tablet of Metformin Hydrochloride by Quality by Design Approach. Research J. Pharm. and Tech 2020; 13(5): 2350-2358. doi: 10.5958/0974-360X.2020.00423.0
30.    Manju Nagpal, Pankaj Rakha, Surinder Goyal, Gitika Dhingra, Sunil Gupta. Comparison of Biorelevant and Compendial Dissolution Media and Prediction of In-vivo Plasma Profile of BCS Class II Drug. Research J. Pharma. Dosage Forms and Tech. 2010; 2(1):37-40.
32.    National Health Surveillance Agency, Brazil. About the studies of pharmaceutical equivalence and comparative dissolution profile. Collegiate Directory. 2010 August; Resolution-RDC No. 31
33.    J. Srinivasa Rao, J. Naga Mallika, M. Sri Madhu Sri, G. Raveendra Babu, M. Prasada Rao, C. Gopinath. Comparative in Vitro Dissolution Assessment of Three Different Brands of Lansoprazole Capsules. Research J. Pharma. Dosage Forms and Tech. 2011; 3(2): 58-66 .
34.    Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Government of India. Guideline for Bioavailability and Bioequivalence Studies. 2005.

Recomonded Articles:

Research Journal of Pharmacy and Technology (RJPT) is an international, peer-reviewed, multidisciplinary journal.... Read more >>>

RNI: CHHENG00387/33/1/2008-TC                     
DOI: 10.5958/0974-360X 

56th percentile
Powered by  Scopus

SCImago Journal & Country Rank

Recent Articles


Not Available