Also available as PDF (figures and tables appear in the PDF).
Introduction: Ototoxicity has been defined as the tendency of certain therapeutic agents and other chemical substances to cause functional impairments and cellular degeneration of the tissues of the inner ear resulting in hearing loss. Objectives: This review is intended to provide details of a standardized preclinical assessment for ototoxicity under the current US FDA guidance documents that represents “industry best practices” for new drug application review of all new chemical entities being developed for human use. Methods: A literature review was conducted to assimilate study strategies that represent “Industry Best Practices” for the conduct of preclinical ototoxicity evaluation for submission to regulatory drug approval agencies. Conclusion: We have proposed a systems-approach and protocol criteria for the valid and reliable assessment of auditory function that can be easily included as a screening tool for ototoxicity within the Tiered Structure of preclinical assays required for approval of any chemical entity targeted for human use.
Keywords: Ototoxicity; Auditory Brainstem Response (ABRs); Cytocochleagram; Histopathology; Otic Microscopy; Best practices
ISSN 2470-4059 http://dx.doi.org/10.17140/OTLOJ-3-e005 Open Journal Editorial Motto of Otolaryngology – Open Journal * *Corresponding author (OTLOJ) Mustafa ÇELİK, MD Department of Otorhinolaryngology Head and Neck Surgery * Bakırköy Dr. Sadi Konuk Training and Mustafa ÇELİK, MD* Research Hospital Zuhuratbaba Mah, Tevfik Sağlam Cad.
No:11, Bakırköy, Istanbul, Türkiye Department of Otorhinolaryngology, Head and Neck Surgery, Bakırköy Dr. Sadi Konuk Training Tel. 0905327065632 and Research Hospital, Zuhuratbaba Mah, Bakırköy, Istanbul, Turkey E-mail: dr.mcelik@yahoo.com Otolaryngology – Open Journal (OTLOJ) has become an important journal in the field Volume 3 : Issue 2 of otolaryngology – head and neck surgery in a very short span of time. Article submissions Article Ref. #: 1000OTLOJ3e005 for OTLOJ have increased rapidly without compromising on the quality of the publications, by performing a critical evaluation of the submissions following the completion of a double-blin- Article History ded peer-review process within a short duration. Of course, the decision governing a manusc- th Received: May 27th, 2017 ript publication is an outcome of the intensive review process undertaken by the experts our th Accepted: May 29th, 2017 valuable reviewers, and the members of our editorial board who work equally hardly to reduce th Published: May 30th, 2017 the length of the the review process.
The motto of OTLOJ is to; Citation ÇELİK M. Motto of otolaryngology – • Implement a rapid double-blinded peer-review process; open Journal (OTLOJ). Otolaryngol • To be indexed with valuable databases such as Pubmed, Index copernicus having been Open J. 2017; 3(2): e5. doi: 10.17140/ OTLOJ-3-e005 already indexed with prestigious databases such as CNKI, OCLC and the like; • To publish more articles and establish a h-index; • To enrich the scientific value and quality of related publications; • To work towards the development of a high impact factor (IF).
IF is an important marker that demonstrates the scientific value of a journal. It is a representation of the the rate at which a journal’s article’ is being cited by other journals or scientific publications. The idea behind the use of impact factor as a parameter to define a Jour- nal’s quality was propounded by Dr. Eugene GARFIELD, the founder of ISI, in 1955; however, this concept was developed and standardised by ISI in the 1960s. Despite the fact that the logic underlying the calculation of the impact factor value is simple, an improved software system is required to perform this computation. Impact factor merit is a measure of the evaluation of Journal quality based on 2-year results; however, using a 5-year impact factor merit has proved to be more valuable for this assessment.
In the position of the Associate Editor, it gives me great pleasure to invite you for the submission of your articles to OTLOJ. The motto of OTLOJ can be implemented effectively with the support of your participation and contribution.
Mustafa ÇELİK, MD Associate Editor Otolaryngology – Open Journal Copyright ©2017 ÇELİK M. This is an open access article distributed under the Creative Commons Attribution 4.0 International License (CC BY 4.0), which permits unrestricted use, dis- tribution, and reproduction in any medium, provided the original work is properly cited.