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  • Vaghela, Khushboo  (6)
  • 1
    Online Resource
    Online Resource
    Regulatory perspective of Drug Repurposing: Methods, Regulatory pathways and Hurdles
    Society of Pharmaceutical Tecnocrats ; 2022
    In:  International Journal of Drug Regulatory Affairs Vol. 10, No. 2 ( 2022-06-19), p. 39-45
    Details
    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
    URL: Article
    DOI: 10.22270/ijdra.v10i2.520
    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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    Online Resource
  • 2
    Online Resource
    Online Resource
    Regulatory requirement for the approval of Generic Drug in Vietnam as per ASEAN Common Technical Dossier (ACTD)
    Society of Pharmaceutical Tecnocrats ; 2022
    In:  International Journal of Drug Regulatory Affairs Vol. 10, No. 3 ( 2022-09-19), p. 66-69
    Details
    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
    URL: Article
    DOI: 10.22270/ijdra.v10i3.532
    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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    Online Resource
  • 3
    Online Resource
    Online Resource
    Regulatory Prospective on Software as a Medical Device
    Society of Pharmaceutical Tecnocrats ; 2022
    In:  International Journal of Drug Regulatory Affairs Vol. 10, No. 4 ( 2022-12-15), p. 13-17
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 10, No. 4 ( 2022-12-15), p. 13-17
    Abstract: Software is becoming increasingly important in medical devices and digital adoption more broadly. It is becoming more important as a medical device in its own right. (1) Currently the use of software in medical market is growing exponentially and many countries have already set guidelines for quality control and clinical evaluation for SaMD. Millions of users use AI based medical device for the diagnosis & Management of diseases. Regulation for the SaMD, IMDRF published guidance document in 2013, in EU they are regulated by EMA, in Australia they are regulated by TGA and in Canada they are regulated by Health Canada. Regulations of these countries and IMDRF were reviewed and articles of challenges in artificial intelligence based medical devices reviewed. There are also many challenges like cybersecurity, safety, and decommissioning, high cost of device and also the design and development process. The objective is to focus on SaMD’s regulations and Challenges.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v10i4.545
    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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    Online Resource
  • 4
    Online Resource
    Online Resource
    Comparisons of registration requirements of Nutraceuticals in Philippines, Tanzania, Cambodia and India
    Society of Pharmaceutical Tecnocrats ; 2022
    In:  International Journal of Drug Regulatory Affairs Vol. 10, No. 4 ( 2022-12-15), p. 18-23
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 10, No. 4 ( 2022-12-15), p. 18-23
    Abstract: "Nutraceuticals" are the combination of Nutrition and pharmaceutical. The term Nutraceutical was given by Dr. Stephen in 1989. A dietary supplement is a product taken by mouth that contains a dietary ingredient (Vitamins, Minerals, Herbs, Amino acids etc.) Numerous definitions and nomenclature for dietary supplements exist worldwide. In India Food Safety and Standards authority (FSSA), defines Nutraceuticals as "foods for special dietary uses or functional foods or health supplements". In Philippines Nutraceuticals are known as food supplement & dilatory supplement. In Sudan, Nutraceuticals are known as dietary supplement & health product .In Cambodia Nutraceuticals are known as health supplement product. Every country has their own guidelines, regulatory requirements which deal with regulatory registration procedures of Nutraceuticals. In order to enter the Indian Nutraceutical market, some of the very important areas of focus include product evaluation, actual product analysis, procuring licenses and developing India specific health and label claims.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v10i4.546
    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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    Online Resource
  • 5
    Online Resource
    Online Resource
    Comparison of Dietary Supplements Product Registration requirements in Singapore, Malaysia, Ghana, Zimbabwe and India
    Society of Pharmaceutical Tecnocrats ; 2022
    In:  International Journal of Drug Regulatory Affairs Vol. 10, No. 3 ( 2022-09-19), p. 61-65
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 10, No. 3 ( 2022-09-19), p. 61-65
    Abstract: Nowadays, diet is thought to be much richer than it used to be. The people’s ignorance of the basic principles of nutrition has led a large part of the population to a non-balanced diet that is high in both calories and fat and low in proteins, vitamins and minerals. This is where Dietary supplement comes in role as it is any vitamin, mineral, herbal product, or other ingestible preparation that is added to the diet to benefit health. Dietary supplements are used worldwide and represent a broad category of ingestible products that are distinguishable from conventional foods and drugs. They do not belong to the category of common food neither medicines nor special dietary products and not intended for specific categories of people. It is very important to ensure that any product entering the market completely complies with the regulatory guidelines and requirements. The regulation of dietary supplement in the five countries India, Singapore, Malaysia, Ghana and Zimbabwe is reviewed and compared.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v10i3.531
    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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    Online Resource
  • 6
    Online Resource
    Online Resource
    FDA’s new pharmaceutical quality initiative: Knowledge-aided assessment & structured applications
    Society of Pharmaceutical Tecnocrats ; 2022
    In:  International Journal of Drug Regulatory Affairs Vol. 10, No. 4 ( 2022-12-15), p. 1-7
    Details
    In: International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 10, No. 4 ( 2022-12-15), p. 1-7
    Abstract: This review paper is about FDA’s new pharmaceutical quality initiative: Knowledge-aided assessment & structured applications (KASA). The aim of USFDA is Timely development, assessment, and approval of safe and effective drugs is pivotal for assuring the American public has access to quality medicines. At present, the new drug and generic quality assessment is performed using a written narrative. To modernize the assessment of drug applications, a KASA system has been initiated. KASA could become a system that captures and manages information about a drug product including risk identification, mitigation and communication, and control strategy. It does this through a structured IT framework that could completely replace the current unstructured text-based, narrative assessment.
    Type of Medium: Online Resource
    ISSN: 2321-6794 , 2321-7162
    URL: Article
    DOI: 10.22270/ijdra.v10i4.523
    Language: Unknown
    Publisher: Society of Pharmaceutical Tecnocrats
    Publication Date: 2022
    detail.hit.zdb_id: 2738279-5
    SSG: 15,3
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
    Online Resource
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