The Role of the Regulatory Affairs Professional in Guiding New Drug Research, Development, and Approval

2019 ◽  
pp. 563-582
Author(s):  
S. Albert Edwards
Keyword(s):  
Drug Research ◽  
Research Development ◽  
New Drug ◽  
Regulatory Affairs

The role of human resources in processes of portuguese firms’ RD&I certification and development

2014 ◽  
Author(s):  
Sérgio Gomes ◽  
Vítor Braga ◽  
Alexandra Braga
Keyword(s):  
Human Resources ◽  
Competitive Advantage ◽  
Scientific Knowledge ◽  
Management Systems ◽  
Research Development ◽  
Innovation Activities

Innovation is seen as a competitive advantage that many companies use to ensure the continuity and success of your business.NP 4457:2007 is the Portuguese norm that supports management, based on a model of innovation backed up by interfaces and interaction between technical/scientific knowledge, its specific mechanisms and the overall society.Our paper aims to analyse innovation activities and the involvement of human resources in Portuguese firms certified by NP4457 and associated to the implementation of Research, Development, and Innovation (RD&I) management systems. We have collected the data through IPAC’s database, using a survey administered to all firms.Our results suggest the existence of a Human Resources (HR) involvement policy, customers and suppliers. The involvement of stakeholders with innovation activities results of its acceptance as a mechanism able to generate wealth, with benefits for both firms and the community.

scholarly journals Metabolic Acidosis in Patients with CKD: Epidemiology, Pathogenesis, and Treatment

2021 ◽  
pp. 1-16
Author(s):  
Marcin Adamczak ◽  
Stanisław Surma
Keyword(s):  
Metabolic Acidosis ◽  
Sodium Bicarbonate ◽  
Current Knowledge ◽  
Venous Blood ◽  
The Body ◽  
Hydrogen Ions ◽  
Ckd Progression ◽  
New Drug ◽  
Treatment And Prevention

<b><i>Background:</i></b> Metabolic acidosis in CKD is diagnosed in patients with plasma or venous blood bicarbonate concentration lower than 22 mmol/L. Metabolic acidosis occurs in about 20% of patients with CKD. Metabolic acidosis may lead to dysfunction of many systems and organs as well as CKD progression. Currently, sodium bicarbonate is mainly used for pharmacological treatment of metabolic acidosis in patients with CKD. Veverimer is a new drug dedicated to treatment of metabolic acidosis in patients with CKD. Orally given veverimer binds hydrogen ions in the intestines and subsequently is excreted from the body with feces. Clinical studies have shown that veverimer is effective in increasing serum bicarbonate concentrations in CKD patients with metabolic acidosis. Here, we present review of the epidemiology, pathogenesis, diagnosis, treatment, and prevention of metabolic acidosis in CKD patients. <b><i>Summary:</i></b> Metabolic acidosis is common in patients with CKD and contributes to CKD progression and many complications, which worsen the prognosis in these patients. Currently, sodium bicarbonate is mainly used in metabolic acidosis treatment. The role of the new drug veverimer in the metabolic acidosis therapy needs further studies. <b><i>Key Message:</i></b> The aim of this review article is to summarize the current knowledge concerning the epidemiology, pathogenesis, diagnosis, treatment, and prevention of metabolic acidosis in CKD patients.

Overview of recently approved 505(b)(2) new drug applications (2010-2012): Role of clinical pharmacology

2014 ◽  
Vol 54 (12) ◽  
pp. 1330-1336 ◽  
Author(s):  
Sheetal Agarwal ◽  
Wei Qiu ◽  
Chandrahas Sahajwalla
Keyword(s):  
Clinical Pharmacology ◽  
New Drug

scholarly journals 3-Phenylcoumarins as a Privileged Scaffold in Medicinal Chemistry: The Landmarks of the Past Decade

Molecules ◽  
2021 ◽  
Vol 26 (21) ◽  
pp. 6755
Author(s):  
Maria J. Matos ◽  
Eugenio Uriarte ◽  
Lourdes Santana
Keyword(s):  
Medicinal Chemistry ◽  
Review Paper ◽  
Relevant Literature ◽  
Natural Origin ◽  
Drug Candidates ◽  
Heterocyclic Molecules ◽  
The Past ◽  
New Drug ◽  
Privileged Scaffold

3-Phenylcoumarins are a family of heterocyclic molecules that are widely used in both organic and medicinal chemistry. In this overview, research on this scaffold, since 2010, is included and discussed, focusing on aspects related to its natural origin, synthetic procedures and pharmacological applications. This review paper is based on the most relevant literature related to the role of 3-phenylcoumarins in the design of new drug candidates. The references presented in this review have been collected from multiple electronic databases, including SciFinder, Pubmed and Mendeley.

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.

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