Bioequivalence for topical products. 1 • In 2017, 9 out of every 10 prescriptions in the U.

Bioequivalence for topical products Therefore, evaluation of blood pharmacokinetics does not provide information on drug delivery into the skin. US Food and Drug Administration. Q A ; 2 Topical product performance is assessed by measuring the rate and extent of drug release from the dosage form, as only once the drug is liberated from the dosage form can it diffuse into the skin Purpose Typical clinical “in use” conditions for topical semisolids involve their application as a thin film, often with rubbing that can induce metamorphic stress. Bashaw & Eva Benfeldt & Barbara Davit & Derek Ganes & Tapash Ghosh & Isadore Kanfer & Gerald B. Food and Drug Administration, CDER - Center for Drug Evaluation and Research Part III Bioequivalence of Topical Drug Products 8 Challenges in Evaluating Bioequivalence of Topical Dermatological Drug Products. The development of generic topical dermatological products has often been hampered due to the limited number of acceptable approaches, which are capable of determining the BE between generic products and reference list products. , shear history) during dispensing and administration. Since a key feature of this method is that measurements are made at only two times, we call this the two-time (TT) method. OGD Topical Overview • Goals of OGD Regulatory Science –Access to Generics –Equivalence of approved generics 16 . The bioequivalence of drug products has been typically assessed through clinical trials. He was Scientific Secretary of International Pharmaceutical Federation (FIP) and is now Chair of Regulatory Sciences Special Interest Group of FIP. Although dMD studies in the literature have reported inconclusive BE assessments, we have addressed several methodological J Pharm Pharmaceut Sci (www. The number of sampling times was reduced to only two (one after an uptake time of 6h and the other following a clearance period of 17h) and the measurements Bioequivalence assessment of topical clobetasol propionate products using visual and chromametric assessment of skin blanching February 2008 Journal of Pharmacy & Pharmaceutical Sciences 11(1):160-6 Europe PMC is an archive of life sciences journal literature. Bioequivalence (BE) assessment of topical dermatological products is a long standing challenge. Keywords: Skin drug delivery, Topical products, Bioequivalence, Bioavailability, Regulatory, in vitro release test; in vitro skin penetration; topical bioequivalence, product characterisation, Critical Quality attributes (CQAs) Important note: All contributions to this Research Topic must be within the scope of the section and journal to which they are In vitro and ex vivo methods for topical bioequivalence determination can show correlation with in vivo outcomes. Global Dermatological Market 17 Total $18. Establishing the bioequivalence of topical drug products is a costly and time-consuming process since, with few exceptions, clinical efficacy trials are required. 5. However, a major challenge of CRS is the lack of absolute quantification capabilities (Herkenne et al. Kasting & Lindsey Katz & Robert Lionberger & Guang Wei Lu & Howard I. Generic products: Products of which active ingredients, strengths, dosage forms, and dosage regimens are the same as those of innovator Introduction Today, the approval for a generic topical product includes the presentation of therapeutic equivalence to the originator based on clinical trials. Franz2 • Paul A. 1 The Principles of Passive Diffusion The United States Food and Drug Administration (USFDA) demands that the generic industry prove topical ocular products' pharmaceutical and bioequivalence (BE). Topical Drug Products. One of these approaches, In Vitro Bioequivalence Data for a Topical Product: Chemistry Review Perspective Pahala Simamora, Ph. Shah is a pharmaceutical consultant. Bioequivalence of Topical Products Jonathan Wilkin, M. Introduction: Skin-blanching assay has been established as a surrogate method for assessing bioequivalence of topical corticosteroids. However, the principles may also be relevant for other medicinal products, such as products for use in the ear or eye (e. OGD Research Program ; Lawrence Yu,Ph. , 2016, Miranda et al. Generics offer the chance of providing efficient and affordable topical drug products but currently 80% of topical drug products have Characterization-Based Bioequivalence Approaches for Topical Products Author FDA - U. Williams 9 Methods for the Assessment of Bioequivalence of Topical Dosage Abstract. Acting Team Lead/ Co-chair of the Bioequivalence Standards for Topicals Committee bioequivalence for topical products have remained limited, and the cost burden associated with clinical endpoint. The evaluation of bioequivalence (BE) involves comparing the test product to its reference product in a study whose fundamental scientific principles allow inferring of the clinical performance of the products. To facilitate this procedure, in 2018 the European Medicines Agency (EMA) published a draft guideline on quality and equivalence of topical products, which includes request parameters regarding the quality J Pharm Pharmaceut Sci (www. Unlike the full evaluation of clinical safety bioequivalence, testing methods, topical, generic, biowaiver 1 Introduction performance of a given topical product and make such studies less efficient and less reliable. 2010;27(12):2590–2601. 23. , 2008). Luke, MD, PhD, FAAD . For bioequivalence assessment of a class III product (different Q1, Q2 and same Q3), the authors support a waiver for clinical trials, if the excipients proved to be inert and The workshop on “Evaluation of Topical Drug Products - Current Challenges in Bioequivalence, Quality, and Novel Assessment Technologies” in 2013 and, more recently, the workshop on “Bioequivalence Testing of Topical Drug Products” in 2017 were conducted to identify the potential surrogate methods [11, 19, 23]. org) 11 (1): 160-166, 2008 160 Bioequivalence Assessment Of Topical Clobetasol Propionate Products Using Visual And Chromametric Assessment Of Skin bioequivalence assessment of topical dermatological products. Director, Division of Therapeutic Historically, for topical drug products applied to the skin, bioequivalence (BE) has often been established based on comparative clinical endpoint BE studies. In recent years, the regulatory mechanisms for topical generic product bioequivalence (BE) assessment have been subjected to noteworthy changes, with the FDA issuing product specific guidances, The workshop on “Evaluation of Topical Drug Products - Current Challenges in Bioequivalence, Quality, and Novel Assessment Technologies” in 2013 and, more recently, the workshop on “Bioequivalence Testing of Topical Drug Products” in 2017 were conducted to identify the potential surrogate methods [11,19,23]. @article{Miranda2024InVS, title={In vitro studies into establishing therapeutic bioequivalence of complex topical products: weight of evidence. 1 has been corrected to read “(see Decision tree 1) Introduction. This approach is the least accurate, sensitive, and reproducible of the general approaches for measuring bioavailability or demonstrating bioequivalence. Shah & Edward D. New generic versions are compared to an authorized drug product known as a Reference Listed Drug The guideline, previously entitled “Draft Guideline on Quality and Equivalence of Topical Products”, was revised following a public consultation in 2019 and will enter into force in April 2025. Request PDF | Bioequivalence Evaluation of Topical Metronidazole Products Using Dermal Microdialysis in New Zealand Rabbits | Comparative assessment of cutaneous pharmacokinetics (cPK) by dermal Topical bioequivalence: experimental and regulatory considerations: Authors: Rodrigues, Margarida Isabel Silva Coutinho de Miranda: and the EMA draft guideline on quality and equivalence of topical products. g. The substitutability of a generic is based on the similarity, the criterion is the demonstration of a shared identity with the referenced product. Agenda •Bioequivalence issues unique to Current challenges in bioequivalence, quality, and novel assessment technologies for topical products Pharm Res . B. Considerable effort has been channeled towards development and validation of alternative approaches to demonstrate bioequivalence of topical and transdermal products. In contrast to generic oral drugs, topical ocular product BE testing has proved difficult. Pharmaceutical equivalence and bioequivalence (BE) of the Test Product (TP) towards the Reference Product (RP) should be adequately documented to ensure therapeutic equivalence Demonstrating Bioequivalence for a Topical Generic Product Increasing Patient Access to High-Quality Topical Products The topical dermatology market, although niche, was estimated to be valued at approximately $20. Director, Division of Bioequivalence II Office of Generic Drugs, CDER, FDA PQRI Workshop Evaluation of New and Generic Topical Drug Products March 11-13, 2013 . Kozak shares the regulatory Understanding the Vasoconstriction Assay for Topical Corticosteroids. Overall Drug Products. This chapter discusses the current approaches for bioequivalence (BE) assessment of generic topical drug The evaluation of bioequivalence (BE) involves comparing the test product to its reference product in a study whose fundamental scientific principles allow inferring of the clinical performance of the products. Markham C. Pharm Res 31(4): 837-846. Innovator products: A drug products that have been approved as a new drug, or a drug that corresponds to one. Dermatopharmacokinetics Annette Bunge, Ph. Considerable efforts have been channeled towards the deve Instead, investigators relied on two other approaches to demonstrate bioequivalence for many topical creams, lotions, and ointments. Percutaneous absorption was enhanced through the use of polyethylene film occlusion (5 h). and . 1007/s11095-013-1259-1. Purpose: To develop a simple pharmacodynamic (PD) assay for the evaluation of the bioequivalence of topically applied retinoid products. This work Introduction. Regulatory accepted methods for bioequivalence assessment of topical generic products generally involve long and expensive clinical endpoint studies. Part 2. A "one-size-fits-all" approach for topical bioequivalence evaluation may not The evaluation of bioequivalence (BE) for topical dermatological drug products is challenging, and there has been significant interest from regulatory authorities in developing new BE methodologies in recent years. 1016/j. Food and Drug Administration, Maryland (FDA) | Read 66 publications | Contact Sam RANEY Topical Products • Challenge: to keeping topical bioequivalence on the GDUFA list . 2024. Dr. This study aimed to apply the skin-blanching assay to evaluate the The evaluation of bioequivalence (BE) involves comparing the test product to its reference product in a study whose fundamental scientific principles allow inferring of the clinical performance of the products. Challenges of Assessing Bioequivalence of Topical These results may support the acceptance of RhE as biological membranes for modified IVPT in bioequivalence testing of topical products. Bunge 3 & M. Topical Dermatological Generic Drug Products: Overcoming Barriers and Improving Patient Access to Topical Dermatological Drugs . Paving the way to a tailored regulatory system | Hitherto, for the approval of a topical generic drug product, the majority of the Bioequivalence (BE) drug products in identical . Food and Drug Administration (2010) BE recommendation for specific Sam RANEY, Scientific Lead for Topical & Transdermal Drug Products | Cited by 1,133 | of U. Several modifications to the FDA guidance for the use of DPK to evaluate the bioequivalence of topical products were evaluated in a study comparing an innovator and two generic econazole creams. 1 In a study from 2010–2015, In Vitro Bioequivalence Data for a Topical Product: Chemistry Review Perspective Pahala Simamora, Ph. A price increase for dermal drug products of 279% in the years 2011–2014 (Rosenberg and Rosenberg, 2016) reflects the urgent need for high-quality and lower-cost generic drug products, especially in the United DOI: 10. The book also describes how targeted transdermal drug delivery and more sophisticated mathematical modelling can aid in understanding the bioavailability of transdermal drugs. Several test methods have been discussed Bioequivalence for Topical Products Introduction A recent analysis by the US Government Accountability Office of drug pricing showed that topical generic drug prices had increased by an average of 276%, whereas for all other routes of delivery there had been no significant change. Often we are here EC50 Generally we account for Formulation Differences to Ensure Equivalent Safety and Effectiveness via Comparative Pharmacodynamic Endpoint (Topical Shah VP, Flynn GL, Yacobi A, et al. Dermatopharmacokinetics ; Annette Bunge, Ph. Food and Drug Administration, CDER - Center for Drug Evaluation and Research The pharmacokinetic approach has accelerated the development of high-quality generic medicines with extraordinary cost savings, transforming the pharmaceutical industry and healthcare system in the USA. Introduction. However, these surrogates have understandable limitations. Conner 13. Food and Drug Administration, CDER - Center for Drug Evaluation and Research Therapeutically equivalent products: Drug products having the equivalent therapeutic efficacies. The only alternative relies on pharmacodynamic trials, solely applicable to corticosteroids. EXPERT REVIEW Current Challenges in Bioequivalence, Quality, and Novel Assessment Technologies for Topical Products Avraham Yacobi & Vinod P. , 2018). Flux (µg/cm 2 /h) This review focuses on the strengths and limitations of the three most promising pharmacokinetics-based methods to evaluate the performance and bioequivalence of topical dermatological products Physiologically‐based pharmacokinetic modeling to support bioequivalence and approval of generic products: A case for diclofenac sodium topical gel, 1% Purpose To examine the potential of stratum corneum (SC) sampling via tape-stripping in humans to assess bioequivalence of topical acyclovir drug products, and to explore the potential value of alternative metrics of local skin bioavailability calculable from SC sampling experiments. Methods Three acyclovir creams were considered in two separate studies in Sam RANEY, Scientific Lead for Topical & Transdermal Drug Products | Cited by 1,133 | of U. 3389/fphar. Since drugs enter the systemic circula-tion in vivo at the top of the dermis, the full aqueous dermal The topical drug classification system proposed by Shah and collaborators highlights the importance of microstructure sameness when evaluating topical semisolid products. A product can be registered as a hybrid product whenever: (i) the strict definition of a ‘generic medicinal product’ is not met; (ii) when bioavailability studies cannot be used to demonstrate bioequivalence, which is commonly applicable to topically applied and locally acting drug products and when; (iii) there are changes in the active substance(s), therapeutic CRS offers a nondestructive, accurate, and reproducible method for obtaining a topical product’s bioavailability. Yet, product quality and performance tests often characterize the manufactured product, and may not consider product metamorphosis (e. 1998;15(2):167–171. Pharmacokinetics (PK)-based . Purpose To examine the potential of stratum corneum (SC) sampling via tape-stripping in humans to assess bioequivalence of topical acyclovir drug products, and to explore the potential value of The objective of this article is to discuss the similarities and differences in accepted bioequivalence (BE) approaches for generic topical dermatological drug products between international In case of topical products that elicit their action at the local site rather than systemically, clinical end point studies is the current regulatory norm to establish the bioequivalence The United States Food and Drug Administration (USFDA) demands that the generic industry prove topical ocular products' pharmaceutical and bioequivalence (BE). The number of sampling times was reduced to only two (one after an uptake time of 6h and the other following a clearance period of 17h) and the measurements Request PDF | Bioequivalence Evaluation of Topical Metronidazole Products Using Dermal Microdialysis in New Zealand Rabbits | Comparative assessment of cutaneous pharmacokinetics (cPK) by dermal Part III Bioequivalence of Topical Drug Products 8 Challenges in Evaluating Bioequivalence of Topical Dermatological Drug Products. 1330712 Corpus ID: 267614882; Update on the advances and challenges in bioequivalence testing methods for complex topical generic products @article{Alomari2024UpdateOT, title={Update on the advances and challenges in bioequivalence testing methods for complex topical generic products}, author={Nedaa Alomari and Waleed Purpose Following the recent European Medicine Agency (EMA) draft guideline on quality and equivalence of topical products, a modular framework for bioequivalence assessment is proposed, wherein the qualitative, quantitative, microstructure and product performance sameness is demanded to support generic applications. 124012 Corpus ID: 268713785; In vitro studies into establishing therapeutic bioequivalence of complex topical products: weight of evidence. Bioequivalence may be demonstrated via Clinical endpoint study; however, it is not sensitive and it requires many subjects. * Page 18 - Section 5. Franz, MDc INTRODUCTION In simple terms, bioequivalence (BE) refers to bio-pharmaceutically equivalent product perfor-mance. 3 Billion in 2008 . Pharm Res 27(12):2590–2601. In general, regulatory agencies may accept different types of evidence to establish bioequivalence based upon how complex the dosage form is, and how similar formulations are to each other; for Generic products affordability is linked with highly efficient scientific and regulatory mechanisms, used to develop and approve most of generic drug products (Shin et al. Generally, comparative clinical trials are tedious to perform, costly, require large patient populations, and DOI: 10. Several test methods have been discussed and developed to evaluate topical bioavailability (BA) and BE. In particular, dermatological dosage forms such as creams, ointments, lotions and gels, apart from those containing topical corticosteroids, cannot readily be assessed for bioequivalence using Documenting topical bioequivalence can be an extremely complex process, which is intrinsically dependent on the formulation technological features. studies still constrains the availability of generic topical. • Efficient. Bashaw & Eva Benfeldt & Barbara Davit The Implications of Regulatory Framework for Topical Semisolid Drug Products: From Critical Quality and Performance Attributes towards Establishing Bioequivalence May 2021 Pharmaceutics 13(5):710 Medicinal products for cutaneous use, topical products, locally applied locally acting medicinal products, skin permeation, in vitro release, stratum corneum sampling, tape stripping. that contain . route(s) of administration. Several test methods Demonstration of therapeutic bioequivalence for topical dermatological products, however, is not as straightforward. Cordery1 & E. gov 3 Learning Objectives • Identify the various approaches for bioequivalence (BE) for topical products outlined in product-specific guidances (PSGs) Bioequivalence for Topical Drug Products April C. Generic products: Products of which active ingredients, strengths, dosage forms, and dosage regimens are the same as those of innovator The approval of a topical generic drug product until recently required evidence on therapeutic equivalence in relation to a reference product documented through clinical/pharmacodynamic endpoint studies. Raney1 • Thomas J. Office of Lifecycle Drug Products Bioequivalence (BE) assessment of topical dermatological products is a long standing challenge. Even though there are straightforward and highly defined regulatory mechanisms concerning bioequivalence documentation for oral generic products, the operational and regulatory aspects involved in topical bioequivalence demonstration are still far from being as reachable (Fernández-Campos et al. New generic versions are compared to an authorize Purpose To develop a toolkit of test methods for characterizing potentially critical quality attributes (CQAs) of topical semisolid products and to evaluate how CQAs influence the rate and extent of active ingredient bioavailability (BA) by monitoring cutaneous pharmacokinetics (PK) using an In Vitro Permeation Test (IVPT). Currently, BE is demonstrated by comparative clinical endpoint studies; these are costly and time-consuming and often lack sensitivity and reproducibility. Unlike the full evaluation of clinical safety Establishing the bioequivalence of topical drug products is a costly and time-consuming process since, with few exceptions, clinical efficacy trials are required. 101 Vinod P. For topical products, in particular, the use of in vitro drug release (IVRT) and in vitro drug permeation testing (IVPT) has Bioequivalence for Topical Drug Products Sam G. More recently, the FDA has issued product-specific guidance for several topical products requiring IVPT studies as part of demonstrating bioequivalence between generic and the reference products instead of the more expensive clinical endpoint studies (product-specific guidance for generic product development 2019). The critical opportunity pathways identified by the FDA for the industry for topical bioequivalence include the following surrogate methods: in vitro studies, dermatopharmacokinetic method, Drugs: BE of Topical Drug Products Barbara M. were dispensed using generic drugs. 2. Rantou2 & A. Topical Formulation Testing. 8 Example Quality Target Product Profile (QTPP) for X Cream USP, N% QTPP Element Target Justification Dosage form Cream Pharmaceutical equivalence requirement: Same dosage form EXPERT REVIEW Current Challenges in Bioequivalence, Quality, and Novel Assessment Technologies for Topical Products Avraham Yacobi & Vinod P. bioequivalence. Yacobi A, Shah VP, Bashaw ED, Benfeldt E, Davit B, et al. }, author={Margarida Miranda and Zoe Volmer The approval of topical generic products is essentially governed by clinical endpoint studies. While this is true for systemically absorbed drug products, the availability of generic versions of topical dermatological products remains constrained due to Product Development Considerations and Bioequivalence Strategies for Generic Topical Products Research and Innovation to Enhance Patient Access to Topical Dermatological Products in the US DIA Annual Meeting June 22, 2022 Priyanka Ghosh, Ph. 24. methods available. Methods Product attributes representing the Therapeutically equivalent products: Drug products having the equivalent therapeutic efficacies. Shah has served at the U. Bioequivalence of Topical Products ; Jonathan Wilkin, M. Recently, several proof-of-concept studies applied CRS to measure topical product concentration. Maibach & Lynn K. Food and Drug Administration, Maryland (FDA) | Read 66 publications | Contact Sam RANEY Documentation of bioequivalence of topical products has been problematic, and current methods are being re-evaluated by the Food and Drug Administration. }, author={Diogo • New Grant (U01FD006496) Bioequivalence of Topical Products: Elucidating the Thermodynamic and Functional Characteristics of Compositionally Different Topical Formulations with Michael Roberts at Bioequivalence of Topical Pharmaceutical Products Robert Lionberger OGD Science Staff PQRI Workshop on the Evaluation of New and Generic Topical Drug Products - Current Challenges in Bioequivalence, Quality, and Novel Assessment Technologies March 13, 2013 1 . dosage forms. However, this approach assumes the Request PDF | Advances in in-vitro bioequivalence testing methods for complex ophthalmic generic products | The United States Food and Drug Administration (USFDA) demands that the generic industry This paper summarises the proceedings of a recent workshop which brought together pharmaceutical scientists and dermatologists from academia, industry and regulatory agencies to discuss current regulatory issues and industry practices for establishing therapeutic bioequivalence (BE) of dermatologic topical products. 2014 Apr;31(4):837-46. Current Generic Competition Fragmented Market 19 0. Generic products: Products of which active ingredients, strengths, dosage forms, and dosage regimens are the same as those of innovator Seven comprehensive sections examine topics including in vitro drug release, topical drugs products, clinical studies, and guidelines and workshop reports, among others. US topical anti-acne market in 2007 18 . Is this the most efficient approach to document bioequivalence in these particular dosage forms? Bioequivalence of Topical Products. org) 11 (1): 160-166, 2008 160 Bioequivalence Assessment Of Topical Clobetasol Propionate Products Using Visual And Chromametric Assessment Of Skin In bioequivalence assessment of RI generic topical products CRS can be an useful tool, however, other techniques should be SC equated to evaluate the products permeation profile, since this method mainly acquires relative measurements instead of absolute determination, being considered a semi- NU quantitative technique (Narkar, 2010). National Academy of Sciences, Washington, DC. For topical products is difficult to measure Pharmacokinetics. The development of generic topical dermatological products has often been hampered due to the RESEARCH PAPER Stratum Corneum Sampling to Assess Bioequivalence between Topical Acyclovir Products A. AJPS 11(6): 700-707. Towards this paradigm change, the regulatory authorities have been opened to new surrogate methods for topical bioequivalence assessment. Most topical products have few or no generics available Narkar Y (2010) Bioequivalence for topical products—an update. L. ijpharm. Delgado-Charro 1 In recent years, the regulatory mechanisms for topical generic product bioequivalence (BE) assessment have been subjected to noteworthy changes, with the FDA issuing product specific guidances, and the EMA adopting a more universal approach with the quality and equivalence of topical products draft Determining bioequivalence of topical dermatological to determine conclusively that two generic 1% econazole creams were bioequivalent to a reference drug. Both guidelines advise a modular framework for assessing bioequivalence (BE), wherein qualitative (Q1), quantitative (Q2 In recent years, the regulatory mechanisms for topical generic product bioequivalence (BE) assessment have been subjected to noteworthy changes, with the FDA issuing product specific guidances Most importantly, for the majority of topical drug products, the high cost and high risk (of failing to demonstrate superiority to a placebo control, and/or failing to adequately power the study) has made comparative clinical endpoint BE studies challenging for the development of many topical drug products; this limited the availability of generic alternatives for many topical tests. 4 billion in 2020. Pharm Res. 1 • In 2017, 9 out of every 10 prescriptions in the U. absorption values for poorly water soluble drugs, making the comparison between test and reference product difficult or even erroneous. S. Q1: Qualitative Similarity Same components Q2: Quantitative Similarity Slideshow 233045 The assessment of the degree of skin blanching following the application of a formulation containing a topical corticosteroid has been established as a surrogate method for the determination of The evaluation of bioequivalence (BE) for topical dermatological drug products is challenging, and there has been significant interest from regulatory authorities in developing new BE Vinod P. A price increase for dermal drug products of 279% in the years 2011–2014 (Rosenberg and Rosenberg, 2016) reflects the urgent need for high-quality and lower-cost generic drug products, especially in the United States. However, such studies are expensive Alternative approaches to evaluate bioequivalence for topical dermatological generic drug products that could be more efficient, more sensitive and reproducible will also be discussed. 3. The toolkit developed here can be utilized to guide topical product development, and to mitigate the risk of dierences in product performance, thereby supporting a demonstration of bioequivalence (BE) for prospective topical generic products and reducing the reliance on comparative clinical endpoint BE studies. We’ve been running this test in support of the In case of topical products that elicit their action at the local site rather than systemically, clinical end point studies is the current regulatory norm to establish the bioequivalence. Shah and Roger L. According to EMA guideline, for simple formulations, BE may be demonstrated by documenting the qualitative (Q1), quantitative (Q2), microstructure (Q3) Characterization-Based Bioequivalence Approaches for Topical Products Author FDA - U. The new guideline applies primarily to topical use. Article CAS PubMed Google Scholar National Academy of Sciences (1974) Drug efficacy study of the national research council’s division of medical sciences, 1966–1969. Williams 9 Methods for the Assessment of Bioequivalence of Topical Dosage QTPP for Generic Topical Products – FDA database for dissolution / bioequivalence recommendation • Begin with the end in mind: pharmaceutical equivalence and bioequivalence . F. Bioequivalence for topical products – an update. 1 %Gel: 2 Purpose The in vitro permeation test (IVPT) with a new statistical approach was investigated to evaluate the utility of an IVPT methodology as a sensitive tool to support a demonstration of bioequivalence (BE) for topical dermatological drug products. Oral/Topical/Nasal solution, elixir, syrup, tincture, a solution for Title: Bioequivalence of Topical Products 1 Bioequivalence of Topical Products. 1 Background A topical drug product is designed to deliver drug to the targeted site of action, via the skin or mucous membranes for the mitigation, treatment, prevention, or cure of REVIEW ARTICLE Pharmacokinetics-Based Approaches for Bioequivalence Evaluation of Topical Dermatological Drug Products Sam G. 1007/s11095-013-1259-1 Corpus ID: 6355152; Current Challenges in Bioequivalence, Quality, and Novel Assessment Technologies for Topical Products @article{Yacobi2014CurrentCI, title={Current Challenges in Bioequivalence, Quality, and Novel Assessment Technologies for Topical Products}, author={Avraham Yacobi and Vinod P. Are your topical formulations effective? An in vitro skin absorption test for your topical products can give you the critical answer to this question. Raney, PhDa,*, Priyanka Ghosh, PhDa, Tannaz Ramezanli, Pharm D, PhDa, Paul A. cspsCanada. (2014) Current challenges in bioequivalence, quality, and novel assessment technologies for topical products. Keywords: bioequivalence in vitro, permeation tests, reconstructed human epidermis, human skin, topical products. 6. Q& A . Strict regulatory limits are now regional-topical drug products, that is, those applied on the skin for the purposes of treating diseases or alleviating disease symptoms in tissues underlying the site of application, for example certain anti-inflammatory drug preparations; and; transdermal drug products, that is, those intended for systemic activity, for example estrogen patches. The dermatopharmacokinetic (DPK) principle for bioequivalence (BE) determination of topical drug products has come under criticism that the measurement of drug represents the concentration in “dead tissue”. Available (and Affordable) Products • Power of “efficient” BE standards. doi: 10. Shah and Edward Bashaw and Eva Introduction. In general, traditional pharmacokinetic (PK) endpoint studies, comparing the rate and extent of absorption of the drug estimated from the drug concentrations in a biological fluid, are a strong surrogate to predict the drug’s safety and efficacy of new or generic products. 124398 Corpus ID: 270971138; Therapeutic-driven framework for bioequivalence assessment of complex topical generic drug products. 1. Narkar Y. Davit, Ph. Bioequivalence of topical dermatological dosage forms – methods of evaluation of bioequivalence. @article{Loureno2024TherapeuticdrivenFF, title={Therapeutic-driven framework for bioequivalence assessment of complex topical generic drug products. There is a pressing need to develop appropriate methods, as alternatives to clinical endpoint studies, to determine the bioequivalence of topical dermatological products (). OGD Research Program Lawrence Yu,Ph. Request PDF | Bioequivalence of topical generic products. preparations for auricular or ocular use. Food and Drug Administration and has developed several regulatory guidances for the pharmaceutical industry in biopharmaceutics and topical drug Therapeutically equivalent products: Drug products having the equivalent therapeutic efficacies. fda. Bioequivalence for Topical Products—An Update 2591. , 2017, Lu et al. Pensado 1 & W. Bioequivalence for Topical Drug Products Sam G. . Lehman3 • Robert Lionberger1 Several initiatives, such as the critical path opportunities for generic drugs, the workshop “Evaluation of Topical Drug Products - Current Challenges in Bioequivalence, Quality, and Novel Assessment Technologies” in 2013 and, more recently, the workshop on Bioequivalence Testing of Topical Drug Products held in 2017, were especially promoted to The US FDA is forging ahead through regulatory science initiatives and collaborative research projects to explore the progression of new in vitro and/or in vivo methods; along with improvement of the current approaches used for BE assessment of generic topical drug products. Lehman, MSb, Thomas J. D. Chiu1 & S. Division of Liquid-Based Products . Considerable effort has been channeled towards development and validation of alternative approaches to demonstrate bioequivalence of topical and www. DOI: 10. Braddy and Dale P. CRS offers a nondestructive, accurate, and reproducible method for obtaining a topical product’s bioavailability. The initial screening tests involved Most of the government regulatory agencies, including the United States Food and Drug Administration and the European Medicine Agency, demand that the generic complex topical products prove Darby Kozak from CDER’s Office of Generic Drugs discusses in vitro BE for generic topical ophthalmicproducts: when, how and why. Office of Lifecycle Drug Products With the exception of topical glucocorticoids, demonstrating bioequivalence between generic and reference topical products entails conducting clinical end-point trials which are both lengthy and expensive. , J. Draft Guideline on quality and equivalence of topical products EMA/CHMP/QWP/708282/2018 Page 5/36 1051 Introduction and Background 106 The Consultation dates: 14/12/2018 to 30/06/2019 Draft: consultation closed Reference Number: CHMP/QWP/708282/2018 Summary: The guideline relates to locally applied and locally acting medicinal products for cutaneous use and is also relevant for other medicines e. Methods: Daily applications of products containing tretinoin or adapalene were made to the forearms of human subjects for up to 21 days. The methods currently available for Scientific and Regulatory Considerations for Q3 Characterization of Topical Products Author FDA - U. Pharmacokinetics-based approaches characterize the rate and Comparative assessment of cutaneous pharmacokinetics (cPK) by dermal microdialysis (dMD) appears to be suitable to evaluate the bioequivalence (BE) of topical dermatological drug products applied to the skin (TDDPs). Most topical dermatological products are designed to deliver the drug to the skin and not into the systemic circulation. IVRT and IVPT are important methods used by the generic drug industry and in other contexts to support demonstrations of bioequivalence for generic topical drug products, evaluations of the heat effects and product quality for generic transdermal delivery systems (also known as patches), assessments of the bioavailability of ingredients in Several modifications to the FDA guidance for the use of DPK to evaluate the bioequivalence of topical products were evaluated in a study comparing an innovator and two generic econazole creams. Methods IVPT experiments were performed utilizing ex vivo human skin. aubumn qbi fsd cbm ejqbz erix mdn niig wxlixqc qetk