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INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT International Peer Reviewed & Refereed Journals, Open Access Journal ISSN Approved Journal No: 2456-4184 | Impact factor: 8.76 | ESTD Year: 2016 Scholarly open access journals, Peer-reviewed, and Refereed Journals, Impact factor 8.76 (Calculate by google scholar and Semantic Scholar | AI-Powered Research Tool) , Multidisciplinary, Monthly, Indexing in all major database & Metadata, Citation Generator, Digital Object Identifier(DOI) |
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| Paper Title: | Reviiew on ICH |
| Authors Name: | Thite Nupur Bapu , Raut Pradnya Jaqbaji , Mokate Shivani Kailas |
| Download E-Certificate: | Download |
| Author Reg. ID: |
IJNRD_202501
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| Published Paper Id: | IJNRD2308014 |
| Published In: | Volume 8 Issue 8, August-2023 |
| DOI: | |
| Abstract: | The international council for harmonization (ICH) is the regulatory requirement to confirm the quality safety and efficacy (QSE) of drugs. It brings a union of drug regulatory experts and Pharma business partners from a few countries such as the European union, Japan, and the United States for harmonisation of technical requirements for drugs in humans. The major aim of ICH is to achieve greater harmonisation in the interpretation and application of technical guidelines for the registration of new active substances obtained by biotechnology by its members; to improve the efficacy of global drug development; to reduce redundant studies; to improve pharmacovigilance activity and quality assurance. |
| Keywords: | • ICH regulatory guideline • Pharmacoepial harmonisation • PSUR (Periodic safety update report) • Good manufacturing practices • Regulatory bodies • Organization of ICH |
| Cite Article: | "Reviiew on ICH", International Journal of Novel Research and Development (www.ijnrd.org), ISSN:2456-4184, Vol.8, Issue 8, page no.a131-a139, August-2023, Available :http://www.ijnrd.org/papers/IJNRD2308014.pdf |
| Downloads: | 000118754 |
| ISSN: |
2456-4184 | IMPACT FACTOR: 8.76 Calculated By Google Scholar| ESTD YEAR: 2016 An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 8.76 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator |
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Published Paper ID:IJNRD2308014 Registration ID: 202501 Published In: Volume 8 Issue 8, August-2023 DOI (Digital Object Identifier): Page No: a131-a139 Country: thane, Maharashtra, india Research Area: Pharmacy Publisher : IJ Publication Published Paper URL : https://www.ijnrd.org/viewpaperforall?paper=IJNRD2308014 Published Paper PDF: https://www.ijnrd.org/papers/IJNRD2308014 |
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ISSN: 2456-4184
Impact Factor: 8.76 and ISSN APPROVED
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