scholarly journals Creating new drugs design patterns.Step one. Pharmaceutical development

2019 ◽  
Vol 1 (1) ◽  
pp. 22-31
Author(s):  
Anna V. Basevich ◽  
Anatoliy S. Dzjuba ◽  
Irina E. Kaukhova ◽  
Polina I. Andreeva
Keyword(s):  
Production Process ◽  
Pharmaceutical Company ◽  
Generic Drug ◽  
Quality By Design ◽  
New Drugs ◽  
Modern Approach ◽  
Control Card ◽  
Pharmaceutical Development ◽  
New Drug ◽  
Conducting Research

To optimize the process of pharmaceutical development, it is necessary to take into account the timeframes of the processes and to track all its key stages. To do this, it is necessary to create an algorithm for conducting research, taking into account the modern approach to pharmaceutical development the concept of Quality by Design. The aim of this work was to create an algorithm of actions in conducting research when developing a new drug that can be used in the production process. Flowcharts were used for depicting algorithms. To account the timeframes of the processes, a Gantt diagram was used. The process of pharmaceutical development when launching a new generic drug has been studied at an operating pharmaceutical company. An algorithm for the actions of staff involved in research is proposed The algorithm minds the concept of Quality by Design. A temporary Gannta scheme and a project manager's control card for the process of pharmaceutical development of a generic drug have been developed. Based on the results of the work, an algorithm of actions in conducting research when developing a new drug that can be used in the production process was proposed.

scholarly journals Comparative Analysis of the QbD Approach in the Pharmaceutical Industry

2019 ◽  
Vol 8 (4) ◽  
pp. 20-26 ◽  
Author(s):  
S. A. Rozhnova ◽  
A. V. Tsypkina
Keyword(s):  
Comparative Analysis ◽  
Drug Development ◽  
Systematic Approach ◽  
New Drugs ◽  
Pharmaceutical Development ◽  
Drug Products ◽  
New Drug ◽  
Eurasian Economic Union ◽  
Pharmaceutical Manufacturers ◽  
Economic Union

Introduction. In the development and introduction of medicines into production, the aim of pharmaceutical manufacturers is to comply with the principle of «Quality-by-Design» (QbD). The International Council for Harmonisation (ICH) has created a number of GxP standards, which have become the regulatory framework for the development of documentation regulating the requirements for the development and production of drug products for countries focused on bringing their products to the world pharmaceutical market. The analysis of the system of regulation of pharmaceutical stages of development of new drugs in the territory of the Eurasian Economic Union was not considered, but for the formation of a systematic approach to the management of the process of pharmaceutical development it is necessary to describe them.Aim. To analyze the possibility of applying the QbD principle to the process of drug development at domestic pharmaceutical enterprises.Materials and methods. Content analysis of scientific publications, system and comparative analysis, sociological methods of research in the field of pharmaceutical development.Results and discussions. Regulatory state requirements to the organization and conduct of drug development procedures are analyzed and described. A number of systemic and sectoral problems typical for domestic pharmaceutical manufacturers in the organization of the development and implementation of new drug products. It is established that one of the main problems for Russian enterprises was the organization of the process as a whole and its individual procedures. To solve the problem of organization of procedures for the development and implementation of new medicines, we formed a methodological support, developed on the basis of a systematic approach and international requirements from the quality system.Conclusion. The main problem identified by the manufacturers is the lack of methodological support for the organization of the processes of pharmaceutical development and the introduction of new drugs in the part of research going to the stage of preclinical and clinical development. The decisions adopted by the Eurasian Economic Union do not affect such aspects of pharmaceutical development regulation as the organization of processes, their management and methodological support aimed at the implementation of the QbD principle. To solve this problem, we have developed guidelines for the implementation of the processes of pharmaceutical development and the introduction of new drug products, which allowed us to apply unified and formalized approaches to their organization. 

Marketing and Pharmaceutical Development

1992 ◽  
Vol 22 (2) ◽  
pp. 221-234
Author(s):  
Maven J. Myers
Keyword(s):  
Cumulative Effect ◽  
Basic Research ◽  
Decision Processes ◽  
New Drugs ◽  
The Political ◽  
Market Demand ◽  
Pharmaceutical Development ◽  
New Drug ◽  
The Cost ◽  
Political Decisions

New pharmaceuticals are developed in response to therapeutic need, scientific feasibility, and market demand. As research and development (R&D) decision processes becomes more sophisticated, marketing input plays a greater role in these decisions. Industry-financed R&D is dependent on basic research financed by government. The political decisions which determine government-financed research are significant determinants of the scientific feasibility of a new drug. Many new drugs offer only minor advantages over existing therapies. The cumulative effect of these minor improvements are significant. In addition, new drugs often increase competition in a market. The Orphan Drug Act has contributed to the marketing of drugs where sufficient market demand may not otherwise exist. While some portion of R&D funds are spent on imitative drugs, the incentive for this use of R&D funds decreases as buyers become more sophisticated and as the cost of marketing a new drug increases.

scholarly journals QUALITY BY DESIGN- A NEW APPROACH TO DRUG DEVELOPMENT

2018 ◽  
Vol 3 (2) ◽  
pp. 8-16
Author(s):  
Rumel Dey ◽  
D.R. Chowdhury
Keyword(s):  
Life Cycle ◽  
Drug Development ◽  
Quality By Design ◽  
Modern Approach ◽  
New Approach ◽  
Pharmaceutical Development ◽  
Pharmaceutical Quality ◽  
Proactive Approach

Quality by design is an essential part of the modern approach to pharmaceutical quality. A new approach to drug development could increase efficiencies, provide regulatory relief and flexibility, and offer important business benefits throughout the product’s life cycle. QbD has become the answer to assist both industry and FDA to move towards a more scientific, risk based, holistic and proactive approach to pharmaceutical development.

Synthesis and Biological Activity of Hydrazones and Derivatives: A Review

2020 ◽  
Vol 20 (5) ◽  
pp. 342-368 ◽  
Author(s):  
Juliana de Oliveira Carneiro Brum ◽  
Tanos Celmar Costa França ◽  
Steven R. LaPlante ◽  
José Daniel Figueroa Villar
Keyword(s):  
Biological Activity ◽  
Medicinal Chemistry ◽  
Biological Activities ◽  
New Drugs ◽  
New Drug ◽  
Cancer Inflammation

Hydrazones and their derivatives are very important compounds in medicinal chemistry due to their reported biological activity for the treatment of several diseases, like Alzheimer’s, cancer, inflammation, and leishmaniasis. However, most of the investigations on hydrazones available in literature today are directed to the synthesis of these molecules with little discussion available on their biological activities. With the purpose of bringing lights into this issue, we performed a revision of the literature and wrote this review based on some of the most current research reports of hydrazones and derivatives, making it clear that the synthesis of these molecules can lead to new drug prototypes. Our goal is to encourage more studies focused on the synthesis and evaluation of new hydrazones, as a contribution to the development of potential new drugs for the treatment of various diseases.

Preclinical Principles of the Investigation of New Drugs

1972 ◽  
Vol 1 (1) ◽  
pp. 1-3
Author(s):  
F J Sanen
Keyword(s):  
Team Work ◽  
New Drugs ◽  
Drug Trials ◽  
New Drug ◽  
Preclinical Investigation ◽  
Research Challenge

From this presentation it becomes apparent that preclinical investigation of new drugs is a multi-disciplinary endeavour. The need for close team work between the various scientists is necessary to meet this complex research challenge successfully. With the development of an ever-increasing number of potent drugs, it is mandatory that the physician responsible for monitoring new drug trials broaden his understanding of preclinical investigations. In doing so, he will soon learn the need for consistent interplay between the preclinical scientist and clinician.

scholarly journals Awareness and Opinions of Research Professionals on India's New Drug and Clinical Trials Regulations: Protocol for a Cross-Sectional Web-Based Survey Study

10.2196/14744 ◽  
2020 ◽  
Vol 9 (1) ◽  
pp. e14744
Author(s):  
Vishal Vennu ◽  
Saurabh Dahiya
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
New Drugs ◽  
Survey Study ◽  
Multiple Sources ◽  
Cross Sectional ◽  
Web Based ◽  
Google Docs ◽  
New Drug ◽  
Research Professionals

Background Although several studies have been conducted and several articles have been published on India's new clinical trial regulations, very few have examined the views of investigators and ethics board members regarding modifications to the previous regulations. Overall, they have neglected to find out the opinions of other relevant professionals, such as research assistants, coordinators, associates, and managers. To our knowledge, no study has yet investigated the awareness and opinions of Indian research professionals on the new 2019 regulations. Objective This study aims to describe the awareness and opinions of Indian research professionals on the new drug and clinical trial regulations. Methods In this cross-sectional, Web-based study, we will conduct an open survey for various Indian research professionals. These professionals will be selected randomly using multiple sources. The survey questionnaires, which have already been validated, were developed using the form function in Google docs. A Web link was generated for participants to take the survey. Descriptive statistics will be shown as means and standard deviations for constant variables, whereas certain variables will instead be shown as numbers and percentages. Results The survey was opened in July 2019. Enrollment has already started and will be completed in three months. The results calculations are expected to begin in October 2019. Conclusions The results of the survey are expected to represent the views of research professionals on the new regulations that will support the development of clinical research and the pharmaceutical industry in India. These regulations are expected to help advance clinical trials, help with the approval of new drugs, and enhance ethical norms in the country. International Registered Report Identifier (IRRID) PRR1-10.2196/14744

2020 New Drug Update

2020 ◽  
Vol 35 (4) ◽  
pp. 151-161
Author(s):  
Daniel A. Hussar ◽  
Laura A. Finn
Keyword(s):  
Rheumatoid Arthritis ◽  
The United States ◽  
New Drugs ◽  
Rating System ◽  
Chronic Obstructive ◽  
Medical Problems ◽  
Idiopathic Constipation ◽  
New Agents ◽  
Obstructive Pulmonary Disease ◽  
New Drug

Five new drugs for medical problems often affecting older people and marketed in the United States in 2019 have been considered in this review. The uses and most important properties of these agents are discussed, and a rating for each new drug is determined using the New Drug Comparison Rating system developed by the author (DAH). Advantages, disadvantages, and other important information regarding each new drug are identified and used as the basis for determining the rating. The drugs considered include new agents indicated for the treatment of patients with Parkinson's disease, rheumatoid arthritis, chronic obstructive pulmonary disease, osteoporosis in postmenopausal women, and chronic idiopathic constipation.

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