A comparative analysis of biopharmaceutics classification system and biopharmaceutics drug disposition classification system: A cross-sectional survey with 500 bioequivalence studies

2013 ◽  
Vol 102 (9) ◽  
pp. 3136-3144 ◽  
Author(s):  
Rodrigo Cristofoletti ◽  
Chang Chiann ◽  
Jennifer B. Dressman ◽  
Silvia Storpirtis
Keyword(s):  
Comparative Analysis ◽  
Classification System ◽  
Drug Disposition ◽  
Biopharmaceutics Classification System ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
System A ◽  
Biopharmaceutics Classification

scholarly journals Consensus-based classification system for intra-operative management of labral tears during hip arthroscopy—aggregate recommendations from high-volume hip preservation surgeons

2021 ◽  
Author(s):  
Ajay C Lall ◽  
Shawn Annin ◽  
Jeff W Chen ◽  
Samantha Diulus ◽  
Hari K Ankem ◽  
...  
Keyword(s):  
Decision Making ◽  
Classification System ◽  
High Volume ◽  
Operative Management ◽  
Labral Repair ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
System A ◽  
Labral Tears ◽  
Comprehensive Classification

Abstract The purpose of this study was to survey high-volume hip preservation surgeons regarding their perspectives on intra-operative management of labral tears to improve decision-making and produce an effective classification system. A cross-sectional survey of high-volume hip preservation surgeons was conducted in person and anonymously, using a questionnaire that is repeated for indications of labral debridement, repair and reconstruction given the torn labra are stable, unstable, viable or non-viable. Twenty-six high-volume arthroscopic hip surgeons participated in this survey. Provided the labrum was viable (torn tissue that is likely to heal) and stable, labral debridement would be performed by 76.92% of respondents for patients >40 years of age and by >84% of respondents for stable intra-substance labral tears in patients without dysplasia. If the labrum was viable but unstable, labral repair would be performed by >80% of respondents for patients ≤40 years of age and > 80% of respondents if the labral size was >3 mm and located anteriorly. Presence of calcified labra or the Os acetabuli mattered while deciding whether to repair a labrum. In non-viable (torn tissue that is unlikely to heal) and unstable labra, labral reconstruction would be performed by 84.62% of respondents if labral size was <3 mm. The majority of respondents would reconstruct calcified and non-viable, unstable labra that no longer maintained a suction seal. Surgeons performing arthroscopic hip labral treatment may utilize this comprehensive classification system, which takes into consideration patient age, labral characteristics (viability and stability) and bony morphology of the hip joint. When choosing between labral debridement, repair or reconstruction, consensus recommendations from high-volume hip preservation surgeons can enhance decision-making.

scholarly journals Monitoring caesarean births using the Robson ten group classification system: A cross-sectional survey of private for-profit facilities in urban Bangladesh

PLoS ONE ◽  
2019 ◽  
Vol 14 (8) ◽  
pp. e0220693 ◽  
Author(s):  
Tahmina Begum ◽  
Herfina Nababan ◽  
Aminur Rahman ◽  
Md Rajibul Islam ◽  
Alayne Adams ◽  
...  
Keyword(s):  
Classification System ◽  
Group Classification ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
For Profit ◽  
System A

scholarly journals Towards computational prediction of Biopharmaceutics Classification System: a QSPR approach

2015 ◽  
Author(s):  
Hai Pham-The ◽  
Huong Le-Thi-Thu ◽  
Teresa Garrigues ◽  
Marival Bermejo ◽  
Isabel González-Álvarez ◽  
...  
Keyword(s):  
Classification System ◽  
Computational Prediction ◽  
Biopharmaceutics Classification System ◽  
System A ◽  
Biopharmaceutics Classification

scholarly journals ICH Guideline for Biopharmaceutics Classification System-Based Biowaiver (M9): Toward Harmonization in Latin American Countries

Pharmaceutics ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 363
Author(s):  
Claudia Miranda ◽  
Alexis Aceituno ◽  
Mirna Fernández ◽  
Gustavo Mendes ◽  
Yanina Rodríguez ◽  
...  
Keyword(s):  
Latin American ◽  
Classification System ◽  
Biopharmaceutics Classification System ◽  
In Vitro Dissolution ◽  
Ich Guidelines ◽  
Latin American Region ◽  
Regulatory Guidelines ◽  
Biopharmaceutics Classification

The biopharmaceutical classification system (BCS) is a very important tool to replace the traditional in vivo bioequivalence studies with in vitro dissolution assays during multisource product development. This paper compares the most recent harmonized guideline for biowaivers based on the biopharmaceutics classification system and the BCS regulatory guidelines in Latin America and analyzes the current BCS regulatory requirements and the perspective of the harmonization in the region to develop safe and effective multisource products. Differences and similarities between the official and publicly available BCS guidelines of several Latin American regulatory authorities and the new ICH harmonization guideline were identified and compared. Only Chile, Brazil, Colombia, and Argentina have a more comprehensive BCS guideline, which includes solubility, permeability, and dissolution requirements. Although their regulatory documents have many similarities with the ICH guidelines, there are still major differences in their interpretation and application. This situation is an obstacle to the successful development of safe and effective multisource products in the Latin American region, not only to improve their access to patients at a reasonable cost, but also to develop BCS biowaiver studies that fulfill the quality standards of regulators in developed and emerging markets.

Elite Athletes’ Perspectives on Providing Whereabouts Information: A Survey of Athletes in the Norwegian Registered Testing Pool / Das Meldesystem und die Anti-Doping-Bestimmungen aus der Sicht der Athleten: Eine Befragung norwegischer Athleten

2009 ◽  
Vol 6 (1) ◽  
Author(s):  
Dag V. Haristad ◽  
Eivind A. Skille ◽  
Miranda Thurston
Keyword(s):  
Information System ◽  
Response Rate ◽  
Elite Athletes ◽  
Unintended Consequences ◽  
Elite Sport ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
System A ◽  
Structured Questionnaire

SummaryThis paper reports on the perspectives of elite athletes on anti-doping work in general and on the whereabouts system in particular, and uses a figurational perspective to explore the unintended consequences of the planned introduction of the whereabouts system. A cross-sectional survey of all the athletes in the Norwegian registered testing pool (n = 236, response rate = 80.8%) was carried out in 2006, using a structured questionnaire. Overall, 70.6% of the athletes agreed that doping was a problem in elite sport in general, but paradoxically only 17.5% agreed that doping was a problem in their own sport. However, more than four in ten (43%) of the athletes agreed that the whereabouts information system made a contribution to a “cleaner” sport. Some athletes thought the system was unfair. The whereabouts information system had, despite all good intentions, outcomes other than those planned and intended by the WADA. Thus, athletes’ views might fruitfully be integrated with other perspectives when anti-doping work is developed further.

scholarly journals COMPARISON OF GLOBAL REGULATORY GUIDELINES FOR AVAILABILITY OF DIFFERENT BIOWAIVER PROVISIONS AND APPLICATION REQUIREMENTS OF BIOPHARMACEUTICS CLASSIFICATION SYSTEM (BCS) BASED BIOWAIVER.

2018 ◽  
Vol 3 (3) ◽  
pp. 8-20
Author(s):  
Jimi Patel ◽  
Priti Mehta ◽  
Vaishali Kothari
Keyword(s):  
Development Strategy ◽  
Classification System ◽  
Drug Application ◽  
Biopharmaceutics Classification System ◽  
New Drug ◽  
Novel Approach ◽  
Permeability Study ◽  
New Drug Application ◽  
Biopharmaceutics Classification

To waive a complete and systemic Bioequivalence (BE) study, Biowaiver or Request for a Biowaiver is a fast track approach to boost the drug development process. Over the past three-four years the Biowaiver market shows greater number of Biowaiver submissions and the wider use of In-vitro permeability study. Biowaiver is a beneficial approach for getting approval of Abbreviated New Drug Application (ANDA) while, BCS based Biowaiver is the novel approach to gain approval for New Drug Application (NDA) as well as ANDA. A Biopharmaceutics Classification System (BCS) based Biowaiver is an exemption from conducting human bioequivalence studies when active ingredient and dosage form meet criteria of solubility, permeability and dissolution. The Paper covers different kind of Biowaiver approaches and the criteria for the applicability of BCS based Biowaivers in the different geographic scopes with regard to global development strategy. There is a comparison of global guidelines on provisions availability for different types of Biowaiver approaches as well as for requirements of Biowaiver based on BCS. From comparison of different global guidelines it is reviewed that most of the guidance resembles to the USFDA, EU and WHO guidelines because most of the regulatory authorities are following the BCS based Biowaiver concept as one of the three main guidance documents (USFDA, EMA, WHO) or a combination of specific requirements.

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