scholarly journals Classification of Companion Diagnostics: A New Framework for Biomarker-Driven Patient Selection

2021 ◽  
Author(s):  
Cynthia Huber ◽  
Tim Friede ◽  
Julia Stingl ◽  
Norbert Benda
Keyword(s):  
Clinical Evidence ◽  
Alternative Therapy ◽  
Drug Approval ◽  
Specific Drug ◽  
Companion Diagnostics ◽  
Regulatory Requirements ◽  
Systematic Classification ◽  
Regulatory Decision ◽  
Risk Balance

Abstract Background Modern personalized medicine strategies builds on therapy companion diagnostics to stratify patients into subgroups with differential benefit/risk. In general, stratification for drug response implies a treatment-by-subgroup interaction. This interaction is usually suggested by the drug’s mechanism of action and investigated in pharmacological research or in clinical studies. In these candidate genes or pathway approaches, either biological reasons for a differential benefit/risk or statistical interaction regarding a pharmacological or clinical endpoint or both may be given. For successful drug approval, demonstration of a positive benefit/risk balance in the intended patient population is required. This also applies to situations with biomarker-selected populations. However, further regulatory considerations relate to the usefulness and plausibility of the selected patients and benefit/risk extrapolations or alternative therapy options in biomarker-negative populations. Methods To facilitate the specification of regulatory requirements and support the design of clinical development programmes, a systematic classification of biomarker-drug pairs is needed, in particular with regard to the expected underlying molecular mechanism and the clinical evidence. Results A classification of five biomarker-drug categories is proposed related to increasing evidence on the biomarker’s predictive value in relation to a specific drug. We classified biomarkers into five ascending categories with increasing evidence on the predictive nature of the biomarker in relation to a specific drug according to the comparative pharmacological and clinical evidence. Conclusions The proposed classification will facilitate regulatory decision-making and support drug development with respect to biomarker-related subgrouping, both, during clinical programme and at the time of marketing authorization application, since the grade of evidence on the differential power of the biomarker can be considered as an indicator for the usefulness of a biomarker-related subgrouping.

scholarly journals A review on drug approval process in US, Europe and India-dossier, bioavailability and bioequivalence studies

2017 ◽  
Vol 1 (04) ◽  
pp. 133-146
Author(s):  
Krishna Madagoni ◽  
Uppunuri Saidireddy ◽  
Himaja .
Keyword(s):  
Drug Product ◽  
Drug Approval ◽  
Approval Process ◽  
Technical Documentation ◽  
Regulatory Requirements ◽  
Regulatory Decision ◽  
New Drug ◽  
Regulatory Affairs ◽  
Regulatory Approach ◽  
Drug Approval Process

Pharmaceutical Regulatory Affairs (PRA) is a vital unit in a pharmaceutical company that successfully drives the Research and Development (RandD) efforts of the company to the market. In the present scenario, countries have different regulatory requirements for approval of a new drug. The single regulatory approach for marketing authorization application (MAA) of a new drug product applicable to various countries (on the basis of single dossier) is utmost difficult. Therefore, the knowledge of exact and detailed regulatory requirements for MAA of each country should be known to establish a suitable regulatory strategy. CTD was developed with the aim to provide a common format for the technical documentation that would significantly reduce the time and resources needed to compile applications for registration of human pharmaceuticals and would ease the preparation of electronic submissions. Bioavailability and bioequivalence testing are essential in the drug development process as they create the foundation for regulatory decision making when evaluating formulation changes and lot-to-lot consistency in innovator products. They also serve as the primary components to demonstrate therapeutic equivalence between generic products and the reference innovator product. This article will focus the similarities and differences in drug approval process and requirements of the documents/CTD specifications to the drug regulatory authorities in the Europe, USA and India also focuses on submission and work flow related to bioavailability and bioequivalence studies.

Regulatory requirements and comparison in approval of new and generic drugs in United States of America and Japan:-Implication for Future strategies

2020 ◽  
Vol 07 ◽  
Author(s):  
Paramjeet Malik ◽  
Neelam Pawar ◽  
Kavita Bahmani
Keyword(s):  
Generic Drugs ◽  
Drug Product ◽  
Drug Approval ◽  
Approval Process ◽  
Regulatory Requirements ◽  
Team Members ◽  
Regulatory Authorities ◽  
Effective Manner ◽  
Review Team

: Safety, efficacy and quality of a therapeutic product is the major concern for the pharmaceutical companies. FDA and PMDA are the main regulatory authorities in USA & JAPAN respectively that ensures the maintenance of these required parameters by forming standard guidelines and process for drug approval. These regulatory authorities’ reviews each step of a pharmaceutical drug product from its discovery phase to marketed product. Dossier plays an important role during the approval process of a drug product, as it allows both applicant and review team members to evaluate the data in an effective manner. A dossier consists of five modules containing informative data of various stages of a drug product but in a brief pattern with folders and subfolders. In the present paper, the authors focus on in-depth review of approval process for new and generic drugs in USA and Japan.

CNN Based Technique for Systematic Classification of Field Photographs

2018 ◽  
Author(s):  
Kavitha D. ◽  
Ramachandra Hebbar ◽  
Vinod P.V. ◽  
Harsheetha M.P. ◽  
Jyothi L. ◽  
...  
Keyword(s):  
Systematic Classification

scholarly journals Physiological Implications of Hydrogen Sulfide in Plants: Pleasant Exploration behind Its Unpleasant Odour

2015 ◽  
Vol 2015 ◽  
pp. 1-6 ◽  
Author(s):  
Zhuping Jin ◽  
Yanxi Pei
Keyword(s):  
Hydrogen Sulfide ◽  
Growth And Development ◽  
Defense Responses ◽  
Plant Responses ◽  
Plant Growth And Development ◽  
Systematic Classification ◽  
Physiological Processes ◽  
Overwhelming Evidence

Recently, overwhelming evidence has proven that hydrogen sulfide (H2S), which was identified as a gasotransmitter in animals, plays important roles in diverse physiological processes in plants as well. With the discovery and systematic classification of the enzymes producing H2Sin vivo, a better understanding of the mechanisms by which H2S influences plant responses to various stimuli was reached. There are many functions of H2S, including the modulation of defense responses and plant growth and development, as well as the regulation of senescence and maturation. Additionally, mounting evidence indicates that H2S signaling interacts with plant hormones, hydrogen peroxide, nitric oxide, carbon monoxide, and other molecules in signaling pathways.

scholarly journals Slovene-English Contrastive Phraseology: Lexical Collocations

2010 ◽  
Vol 7 (2) ◽  
pp. 57-73
Author(s):  
Primož Jurko
Keyword(s):  
English Language ◽  
Focal Point ◽  
Systematic Classification ◽  
Lexical Collocations ◽  
The Difference ◽  
Translation Errors ◽  
Language Pair

Phraseology is seen as one of the key elements and arguably the most productive part of any language. %e paper is focused on collocations and separates them from other phraseological units, such as idioms or compounds. Highlighting the difference between a monolingual and a bilingual (i.e. contrastive) approach to collocation, the article presents two distinct classes of collocations: grammatical and lexical. %e latter, treated contrastively, represent the focal point of the paper, since they are an unending source of translation errors to both students of translation and professional translators. %e author introduces a methodology of systematic classification of lexical collocations applied on the Slovene-English language pair and based on structural (lexical congruence) and semantic (translational predictability) criteria.

scholarly journals Classification of digital stitch lines in machine embroidery

2021 ◽  
Vol 72 (05) ◽  
pp. 538-544
Author(s):  
DANIELA SOFRONOVA ◽  
RADOSTINA A. ANGELOVA
Keyword(s):  
Web Sites ◽  
High Tech ◽  
Apparel Design ◽  
Systematic Classification ◽  
Software Products ◽  
Software Product ◽  
Textile And Apparel ◽  
Large Application ◽  
The Web

Despite the large application of the machine embroidery in textile and apparel design and high-tech clothing items, there is а lack of systematic arrangement of the digital stitch lines, used by embroidery machines and embroidery designers. Since 2010 information on embroidery stitch lines could be mostly found in the web sites of the embroidery machine manufacturers and software product manuals. However, in the instruction manuals the instruments for creating various embroidery objects are simply described without providing systematic information on the types of the stitch lines. Even more, different names of the stitch lines and different ways to achieve the same design are observed. Single authors offer their own classifications based entirely and logically on the stitches of the hand embroidery. Another group of authors relied on already developed techniques and strategies for digitizing stitches in various software products or took into account the final appearance of the stitch lines or their application. Our study aimed to develop a detailed and systematic classification of the digital stitch lines in the machine embroidery, which has not been presented in the literature.

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