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  • 1
    Online Resource
    Online Resource
    Society of Pharmaceutical Tecnocrats ; 2022
    In:  International Journal of Drug Regulatory Affairs Vol. 10, No. 2 ( 2022-06-19), p. 39-45
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 10, No. 2 ( 2022-06-19), p. 39-45
    Abstract: Drug repurposing is a phenomenon that aims at utilising an established and approved drug product or drug substance for an additional clinical indication apart from the one that it was intended for. The reprofiling of drug formulations creates an extensive arsenal of therapeutic options for drug products, thus making the practice a desirable and forthcoming procedure. There are several techniques and methods that have been adopted over the years to evaluate the various possibilities for the repurposing of drugs in search of a wider range of chemical therapeutics. The repurposing of drug products has provided, over the course of time several different advantages to the pharmaceutical industry, and yet remains an uncomprehended and over-looked procedure. The following paper attempts to identify the different benefits that are to be gained from the repurposing of drug products along with the approaches that have been used for the same. Additionally, the paper also discusses the regulatory perspective of drug repurposing, emphasising on the incentives that are available for various pharmaceutical sponsors as well the hurdles that are to be faced during the repurposing of a drug product or drug substance.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2022
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
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  • 2
    Online Resource
    Online Resource
    Society of Pharmaceutical Tecnocrats ; 2022
    In:  International Journal of Drug Regulatory Affairs Vol. 10, No. 1 ( 2022-03-15), p. 51-82
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 10, No. 1 ( 2022-03-15), p. 51-82
    Abstract: Registration of Pharmaceutical drug product in Emerging Market is most demanding task. Regulatory requirements are harmonized in regulated countries by Common technical document (CTD) filing, while there is diversity of requirements in emerging markets. International conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has brought regulatory authorities and pharmaceutical industries of US, Japan and Europe together for various aspects of drug registration but there are is no such harmonized guideline for emerging market except Association of Southeast Asian Nations (ASEAN) and Gulf Co-operation Council (GCC) where harmonization exist in clusters with their mutual concern. The optimization and harmonization requirements has become mandatory and can be examined by the incidence of higher cost involved in availability of drugs, quality requirement of premise and research and development, regional registration requirements. Quality, Safety and Efficacy data has significance importance in dossier registration. Pharmaceutical Industries has to comply with regulatory requirement in Emerging market and for betterment of public Health and safety. The review also explains a brief about different regulatory requirement for Registration of drug product in Emerging market and comparative data for registration of dossier application in Emerging market.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2022
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
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  • 3
    Online Resource
    Online Resource
    Society of Pharmaceutical Tecnocrats ; 2022
    In:  International Journal of Drug Regulatory Affairs Vol. 10, No. 2 ( 2022-06-19), p. 14-27
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 10, No. 2 ( 2022-06-19), p. 14-27
    Abstract: A Drug Master File is a record that consists of detailed, correct data approximately an Active Pharmaceutical Ingredient (API) or Dosage Form of a Finished Product (FP). It is a classified document containing thorough, accurate, and up-to-date information regarding the active medicinal ingredient and medicament. A DMF is divided into two sections: (a) Open part (the Applicant's Part), which includes all of the details needed to determine the quality of a product. And (b) the Closed Part (Restricted Part). The Restricted Part (Closed Part) comprises openly undisclosed manufacturing method knowledge only given to authorized individuals. This compilation aims to offer a comparison of DMF regulatory necessities in addition to the exact data for the registration of lively pharmaceutical ingredients (API) for common drugs in various regulatory governments, including EUROPE (EDQM, EMA), BRAZIL (ANVISA), and SOUTH AFRICA (SAHPRA). This review will provide information on the differences and similarities in the DMF filing requirements in EUROPE, BRAZIL, and SOUTH AFRICA. The regulatory criteria for API registration vary by jurisdiction. Despite the existence and widespread adoption of an ICH-CTD standard format, there are also some limitations. There are a few particular requirements set provided to drug authorities along with the submission. The registration procedure is a regulatory undertaking that permits a person/organization/sponsor/innovator to get permission to participate in the regulation process for fetching marketing authorization/approval.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2022
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
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  • 4
    Online Resource
    Online Resource
    Society of Pharmaceutical Tecnocrats ; 2022
    In:  International Journal of Drug Regulatory Affairs Vol. 10, No. 2 ( 2022-06-28), p. 102-111
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 10, No. 2 ( 2022-06-28), p. 102-111
    Abstract: Cancer is the leading cause of death worldwide and is a well-known fact that it can be cured if detected and treated early. Cancer treatment has evolved from conventional therapies like vinca alkaloids, photodynamic and radiation therapy, chemotherapy to immunotherapy. Recent advances in tumour agnostic therapies based on cancer genetics and molecular features has led to a single drug treating different types of cancers. Next Generation sequencing (NGS) represents an effective way to gather large amount of genomic information about a cancer. The concept of precision medicine goes along with an understanding of the cancer genome as determined by NGS. Thus with an array of cancer diagnosis and treatment options the marketing approval process globally is challenging. This is mainly due to lack of harmonization of guidelines. This review evaluates the approval process of oncology drugs in US, EU and India.  Recent USFDA initiatives like Project Orbis involving multi country collaboration and real time oncology review while EU PRIME and WHO proposed reliance pathway are several global initiatives which accelerates assessment process. New NDCT rules introduced in India in 2019 is one of the key step towards faster availability and accessibility of Cancer drugs in the country. Countries with high resource settings like USA and EU have recognized this and have made several initiatives to provide early access to patients. USA has several pathways for speeding up the regulatory approval process for oncology drugs. India has recently came up with New Drugs and Clinical Trial rules, 2019 (NDCT rules 2019) which laid down the provisions of Provisions of Accelerated approval, Expedited review and Clinical trial waivers ensures faster availability and accessibility  of  cancer drugs in the country. Although a lot of initiatives have already been taken in this direction still there is a strong need to harmonize the requirements globally for faster availability and accessibility of drug in the country for the much-needed patients.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2022
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
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  • 5
    Online Resource
    Online Resource
    Society of Pharmaceutical Tecnocrats ; 2022
    In:  International Journal of Drug Regulatory Affairs Vol. 10, No. 3 ( 2022-09-19), p. 66-69
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 10, No. 3 ( 2022-09-19), p. 66-69
    Abstract: Drug approval process differs from one country to another country. The purpose of this study is to give a comparative overview on generic drug market regulation in ASEAN Countries Cambodia and Vietnam. The aim of study is to facilitate proper knowledge regarding main critical issues, differences as well as similarities of related drug regulation. There is a different requirement for registration of generic product in each regulatory system but also comprises of some similar outline that includes some common rules. These are variances and regulatory hurdles such as Number of batches for submission in dossier, stability conditions, registration of product, analysis, bioequivalence and clinical study requirement. ASEAN countries for generic drug product approval ACTD submitted to country specific authority. For solid oral dosage forms as per ASEAN guideline there are 4 parts have to be submitted. Part I contains Administrative requirements which is not a part of common technical document. Part II is Quality contains 3 sections that are a) Table of Content b) Quality overall Summary c) Body of data. Part III contains Non clinical. Part IV contains Clinical data. For the generic drug product Part III and Part IV is not required.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2022
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
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  • 6
    Online Resource
    Online Resource
    Society of Pharmaceutical Tecnocrats ; 2022
    In:  International Journal of Drug Regulatory Affairs Vol. 10, No. 4 ( 2022-12-15), p. 45-52
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 10, No. 4 ( 2022-12-15), p. 45-52
    Abstract: The medicinal products used in the treatment, prevention, and diagnosis of rare disease like Myoclonus disease, Huntington's disease, Tourette syndrome are called as Orphan drugs, when it comes to defining rare disease and approving them as “Orphan designations.” The Criteria varies from country to country based on severity, prevalence of the disease and alternative therapies available. In 1983, the US government brought the Orphan Drug Act to facilitate and encourage pharmaceutical company to develop orphan drugs without which they show reduced interest in the research and development of these drugs. The reason being their low market value and sales of orphan a drug is so miniscule that it will not enable them to even recover a fraction of the investment made in them. After the inception of “Orphan Drugs” act 4500 orphan designations have been approved, 730 biologic drug products have been approved to treat 250 Orphan designations. In the past decades, orphan designations have doubled in number when compared to its preceding decade but only 1/5th of the developed medications to treat them and received regulatory approval.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2022
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
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  • 7
    Online Resource
    Online Resource
    Society of Pharmaceutical Tecnocrats ; 2022
    In:  International Journal of Drug Regulatory Affairs Vol. 10, No. 1 ( 2022-03-15), p. 1-13
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 10, No. 1 ( 2022-03-15), p. 1-13
    Abstract: Drug repurposing involves the disquisition of using medicines for new remedial purposes. With the increasing waste production, given the costs and tiresome pace of new medicine search, repurposing of medicines already in the market to treat all kinds of conditions is decreasingly getting a selective approval because uses the composites that have been de-risked, with lesser development costs and shorter timelines of developing the drug. Colourful and experimental data approaches have been used for the identification of the medicines to be repurposed. There are also major technical and non-supervisory challenges that need to be addressed. In this review, we present the different kinds of approaches used for medicine repurposing, study the challenges faced by the scientists during repurposing as well as recommend ways by which these challenges could be overcome to help realize the full potential of medicine repurposing. Drug displacing is the repurposing of an already existing medicine for the treatment of a different complaint or medical condition than that for which it was firstly developed. This is one line of scientific exploration which is being pursued to develop safe and effective COVID-19 treatments. Other exploration directions include the discovery of a COVID-19 vaccine and convalescent tube transfusion. Several being antiviral specifics, preliminarily developed or used as treatments for SARS, MERS, HIV/ AIDS, and malaria, have been delved as implicit COVID‐19 treatments, with some moving into clinical trials. Monoclonal antibodies under disquisition for repurposing include anti-IL-6 agents (tocilizumab) and anti-IL-8 (BMS-986253). This is in resemblance to new monoclonal antibody medicines developed specifically for COVID-19.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2022
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
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  • 8
    Online Resource
    Online Resource
    Society of Pharmaceutical Tecnocrats ; 2022
    In:  International Journal of Drug Regulatory Affairs Vol. 10, No. 3 ( 2022-09-15), p. 1-9
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 10, No. 3 ( 2022-09-15), p. 1-9
    Abstract: Background: there is growing concern that medicines supplied to most of the developing countries are of substandard quality. Along with the establishment of strong regulatory systems for ensuring compliance and regulatory law enforcement, manufacturing facilities need to work to implement dependable systems at each stage of the production process to ensure the safety, efficacy, and quality of their products. Objective: the aim of this study was to assess the level of compliance with regulatory requirements by small-scale pharmaceutical manufacturing facilities in Addis Ababa, Ethiopia. Material & Method: A cross-sectional observational study was conducted using a structured questionnaire and checklist to assess the level of compliance of small-scale local pharmaceutical manufacturing facilities to regulatory requirements and also to identify the challenges faced by the manufacturing facilities. Result: This study indicated that the overall implementation status of regulatory requirements in the local small-scale pharmaceutical manufacturing companies is far below the minimum standard set by WHO and the national regulatory authority. Basic on specific regulatory requirement elements compliance: requirements related to QA were 26.9, requirements related to personnel qualification were 38.1, requirements related to Quality control were 25.9, and requirements related to sanitation and hygiene were 15.3. Of the total regulatory requirements, only 26.1% were found to be implemented. Major challenges faced by the local small-scale pharmaceutical manufacturing industry for the implementation of regulatory requirements were: human resource capacity constraints, limited investment, limited support from Governments and other stakeholders, and poor infrastructure. Conclusion: The study demonstrated that level of regulatory requirements implementation in the local small-scale pharmaceutical manufacturers is far below the minimum standard set by the national regulatory authority. Important gaps were reported particularly in materials management, production operations, quality control, and sanitation and hygiene.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2022
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
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  • 9
    Online Resource
    Online Resource
    Society of Pharmaceutical Tecnocrats ; 2022
    In:  International Journal of Drug Regulatory Affairs Vol. 10, No. 2 ( 2022-06-19), p. 73-81
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 10, No. 2 ( 2022-06-19), p. 73-81
    Abstract: Artificial intelligence (AI) algorithms have changed the landscape of Cardio Vascular Disease (CVD) risk assessment and demonstrated a better performance mainly due to its ability to handle the input nonlinear variations. Further, it has the flexibility to add risk factors derived from medical imaging modalities using Computer Vision (CV). Most commonly used algorithms in CVD risk predications were classification and regression tress (CART). Though most of the developed models have shown good accuracy but have not considered risks factors or dependent variables related to specific population which plays an integral role in predicting the risk of CVDs. This Include gender specific clinical risk factors (hormonal changes, bone density etc.), metrological, chronological data, exposure to environmental pollutants, race, genotype, hereditary, dietary intake, physical inactivity, psychological stress etc. Secondly the existing models have not included the weighing and grading of the risks, as all factors won’t contribute equally to the Cardiac Risk. Importantly predictive models can be readily used within the populations in which they were developed but practically they often give a less than satisfactory performance, when applied to another population because of the Inter genetic variations especially in CVDs. India accounts for one-fifth of these deaths worldwide especially in younger population. The results of Global Burden of Disease study state age-standardized CVD death rate of 272 per 100000 populations in India, which is much higher than that of global average of 225. CVDs strike Indians a decade earlier than the western population. For Indians, particular causes of concern in CVD are early age of onset, rapid progression and high mortality rate. Indians are known to have the highest coronary artery disease (CAD) rates, and the conventional risk factors fail to explain this increased risk. In Indian context, aggressive screening tests should begin at an early age and will be beneficial for early detection and treatment to reduce the mortality. Hence there is necessity to develop upgraded AI models specific to a subset of population (Indian, Caucasoid, Dravidian etc.) inclusive of the risk factors in that specific population. Secondly allotting weighing, grading of risk factors in the model will provide accurate cardiac risk prediction compared to other approaches. The regulatory and policy landscape for AI is an emerging issue in jurisdictions globally, including in the European Union and in supra-national bodies like the IEEE, OECD and others. Since 2016, a wave of AI ethics guidelines has been published in order to maintain social control over the technology.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2022
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
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  • 10
    Online Resource
    Online Resource
    Medwin Publishers ; 2022
    In:  Pharmaceutical Drug Regulatory Affairs Journal Vol. 5, No. 1 ( 2022)
    In: Pharmaceutical Drug Regulatory Affairs Journal, Medwin Publishers, Vol. 5, No. 1 ( 2022)
    Abstract: Regulatory Affairs in pharmaceutical industries is a one of the most critical job. Regulatory Affairs is mainly concerned about the lifecycle of healthcare product and it gives tactical, strategic and operation advice to work within regulation to develop safe and effective healthcare product around the World. The work of Regulatory Affairs to nurture and implementing a strategy to guarantee the collective efforts of the drug development team, so that the drug get approval from global regulatory authorities. Regulatory Affairs is a catchy career choice for graduate student from scientific background. Regulatory Affairs is a multitasking job. This job is suitable for those people who enjoys communicating with people, enjoys team work and want to expand their knowledge in pharmaceutical sector. Regulatory Affairs is a very rewarding job. A person who want pursue their job in Regulatory Affairs should have knowledge about ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use).
    Type of Medium: Online Resource
    ISSN: 2642-6315
    Uniform Title: Regulatory Affairs in Pharmaceutical Industry
    URL: Issue
    Language: Unknown
    Publisher: Medwin Publishers
    Publication Date: 2022
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