View in EDS

Regulatory and Ethical Frameworks for First-in-Human Clinical Trials in India: Proceedings of a Codesigned Capacity-Building Workshop.

Saved in:
Bibliographic Details
Title: Regulatory and Ethical Frameworks for First-in-Human Clinical Trials in India: Proceedings of a Codesigned Capacity-Building Workshop.
Authors: Shafiq N; Clinical Pharmacology Unit, Department of Pharmacology, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, 160012, India. nusrat.shafiq.pgi@gmail.com., Kumar A; Clinical Pharmacology Unit, Department of Pharmacology, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, 160012, India., Cherian JJ; Clinical studies and trials Unit, Division of Development Research, Indian Council of Medical Research, V. Ramalingaswami Bhawan, Ansari Nagar, New Delhi, Delhi, 110029, India.; Health Systems and Policy (HSP), Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.; Faculty of Medical Research, Academy of Scientific and Innovative Research (AcSIR), Ghaziabad, Uttar Pradesh, 201002, India., Madan T; Division of Development Research, ICMR Network for Phase 1 Clinical Trials, CSTU, ICMR HQ, New Delhi, Delhi, 110029, India., Kshirsagar N; Former National Chair Clinical Pharmacology, Division of Basic Medical Sciences, Indian Council of Medical Research, New Delhi, Delhi, 110029, India., Mukherjee A; Clinical studies and trials Unit, Division of Development Research, Indian Council of Medical Research, V. Ramalingaswami Bhawan, Ansari Nagar, New Delhi, Delhi, 110029, India.; Faculty of Medical Research, Academy of Scientific and Innovative Research (AcSIR), Ghaziabad, Uttar Pradesh, 201002, India.; Wellcome Trust/India Alliance, New Delhi, India., Vij S; Clinical Pharmacology Unit, Department of Pharmacology, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, 160012, India., Singh PK; Formerly- Senior VP Clinical Trial Management, Lambda Therapeutic Research, Ahmedabad, Gujarat, 382481, India.; Kashiv Biosciences India Pvt. Ltd, Sardar Patel Ring Rd, Ahmedabad, Gujrat, 382210, India., Srivastava G; Office of Oncologic Diseases, U.S. Food and Drug Administration, Silver Spring, MD, 20993, USA., Visala A; Central Drugs Standard Control Organization (CDSCO), FDA Bhavan, ITO, Kotla Road, New Delhi, 110002, India., Kumar A; Aurigene Oncology Limited, Bengaluru, Karnataka, 560100, India., Soman A; Global Regulatory Affairs- CMC, Sun Pharma Advanced Research Co. Ltd. (SPARC), Mumbai, Maharashtra, 400093, India., Kotakonda HK; DMPK & Clinical Pharmacology, Bugworks Research India Pvt Ltd, Bangalore, Karnataka, 560065, India., Joglekar S; Novartis Healthcare Pvt Ltd., Hyderabad, Telangana, 500081, India., Joshi M; Technical Operations, IDRS Labs Pvt Ltd., Bengaluru, Karnataka, 560099, India., Udupa V; Toxicology, Glenmark Pharmaceuticals Limited, Mumbai, Maharashtra, 400026, India., Poomali A; Division of Development Research, ICMR Network for Phase 1 Clinical Trials, CSTU, Indian Council of Medical Research, New Delhi, Delhi, 110029, India., Noronha NB; Division of Development Research, ICMR Network for Phase 1 Clinical Trials, CSTU, Indian Council of Medical Research, New Delhi, Delhi, 110029, India., Gogtay N; Department of Clinical Pharmacology, Seth GS Medical College & KEM Hospital, Mumbai, Maharashtra, 400012, India., Krishnamurthy MN; Department of Clinical Pharmacology, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Centre, Navi Mumbai, Maharashtra, 410210, India.; Homi Bhabha National Institute (HBNI), Mumbai, Maharashtra, 400094, India., Mohapatra S; Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), Guwahati, Assam, 781101, India., Saha N; Centre for Translational and Clinical Research, School of Chemical and Life Sciences, Jamia Hamdard, New Delhi, Delhi, 110062, India., Gota V; Department of Clinical Pharmacology, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Centre, Navi Mumbai, Maharashtra, 410210, India., Pradhan AK; Advisor to CDSCO, New Delhi, Delhi, 110002, India., Chatterjee P; Cell and Gene Therapy R&D and Process Development, Aurigene Oncology Limited, Bangalore, Karnataka, 560100, India., Kumar A; Novartis Healthcare Pvt Ltd, Hyderabad, Telangana, 500081, India., Chaturvedi A; CSR Delivery and Head-RWS India, Hyderabad, Telangana, 500032, India.; Regulatory Writing and Submissions (RWS), Global Clinical Operations (GCO), Novartis Healthcare Pvt Ltd., Novartis Knowledge city, Hyderabad, Telangana, 500032, India., Balasundaram MK; Clinical Pharmacology Unit, Department of Pharmacology, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, 160012, India., Prakash G; Department of Clinical Haematology and Medical Oncology, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, 160012, India., Kakkar AK; Clinical Pharmacology Unit, Department of Pharmacology, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, 160012, India., Malhotra S; Clinical Pharmacology Unit, Department of Pharmacology, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, 160012, India.
Source: Clinical drug investigation [Clin Drug Investig] 2026 Jul; Vol. 46 (7), pp. 683-689. Date of Electronic Publication: 2026 May 26.
Publication Type: Journal Article; Review
Journal Info: Publisher: Adis, Springer International Country of Publication: New Zealand NLM ID: 9504817 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1179-1918 (Electronic) Linking ISSN: 11732563 NLM ISO Abbreviation: Clin Drug Investig Subsets: MEDLINE
Database: MEDLINE Ultimate
FullText Text:
  Availability: 0
Header DbId: mdl
DbLabel: MEDLINE Ultimate
An: 42189405
AccessLevel: 2
PubType: Academic Journal
PubTypeId: academicJournal
PreciseRelevancyScore: 0
IllustrationInfo
Items – Name: Title
  Label: Title
  Group: Ti
  Data: Regulatory and Ethical Frameworks for First-in-Human Clinical Trials in India: Proceedings of a Codesigned Capacity-Building Workshop.
– Name: Author
  Label: Authors
  Group: Au
  Data: <searchLink fieldCode="AU" term="%22Shafiq+N%22">Shafiq N</searchLink>; Clinical Pharmacology Unit, Department of Pharmacology, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, 160012, India. nusrat.shafiq.pgi@gmail.com.<br /><searchLink fieldCode="AU" term="%22Kumar+A%22">Kumar A</searchLink>; Clinical Pharmacology Unit, Department of Pharmacology, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, 160012, India.<br /><searchLink fieldCode="AU" term="%22Cherian+JJ%22">Cherian JJ</searchLink>; Clinical studies and trials Unit, Division of Development Research, Indian Council of Medical Research, V. Ramalingaswami Bhawan, Ansari Nagar, New Delhi, Delhi, 110029, India.; Health Systems and Policy (HSP), Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.; Faculty of Medical Research, Academy of Scientific and Innovative Research (AcSIR), Ghaziabad, Uttar Pradesh, 201002, India.<br /><searchLink fieldCode="AU" term="%22Madan+T%22">Madan T</searchLink>; Division of Development Research, ICMR Network for Phase 1 Clinical Trials, CSTU, ICMR HQ, New Delhi, Delhi, 110029, India.<br /><searchLink fieldCode="AU" term="%22Kshirsagar+N%22">Kshirsagar N</searchLink>; Former National Chair Clinical Pharmacology, Division of Basic Medical Sciences, Indian Council of Medical Research, New Delhi, Delhi, 110029, India.<br /><searchLink fieldCode="AU" term="%22Mukherjee+A%22">Mukherjee A</searchLink>; Clinical studies and trials Unit, Division of Development Research, Indian Council of Medical Research, V. Ramalingaswami Bhawan, Ansari Nagar, New Delhi, Delhi, 110029, India.; Faculty of Medical Research, Academy of Scientific and Innovative Research (AcSIR), Ghaziabad, Uttar Pradesh, 201002, India.; Wellcome Trust/India Alliance, New Delhi, India.<br /><searchLink fieldCode="AU" term="%22Vij+S%22">Vij S</searchLink>; Clinical Pharmacology Unit, Department of Pharmacology, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, 160012, India.<br /><searchLink fieldCode="AU" term="%22Singh+PK%22">Singh PK</searchLink>; Formerly- Senior VP Clinical Trial Management, Lambda Therapeutic Research, Ahmedabad, Gujarat, 382481, India.; Kashiv Biosciences India Pvt. Ltd, Sardar Patel Ring Rd, Ahmedabad, Gujrat, 382210, India.<br /><searchLink fieldCode="AU" term="%22Srivastava+G%22">Srivastava G</searchLink>; Office of Oncologic Diseases, U.S. Food and Drug Administration, Silver Spring, MD, 20993, USA.<br /><searchLink fieldCode="AU" term="%22Visala+A%22">Visala A</searchLink>; Central Drugs Standard Control Organization (CDSCO), FDA Bhavan, ITO, Kotla Road, New Delhi, 110002, India.<br /><searchLink fieldCode="AU" term="%22Kumar+A%22">Kumar A</searchLink>; Aurigene Oncology Limited, Bengaluru, Karnataka, 560100, India.<br /><searchLink fieldCode="AU" term="%22Soman+A%22">Soman A</searchLink>; Global Regulatory Affairs- CMC, Sun Pharma Advanced Research Co. Ltd. (SPARC), Mumbai, Maharashtra, 400093, India.<br /><searchLink fieldCode="AU" term="%22Kotakonda+HK%22">Kotakonda HK</searchLink>; DMPK & Clinical Pharmacology, Bugworks Research India Pvt Ltd, Bangalore, Karnataka, 560065, India.<br /><searchLink fieldCode="AU" term="%22Joglekar+S%22">Joglekar S</searchLink>; Novartis Healthcare Pvt Ltd., Hyderabad, Telangana, 500081, India.<br /><searchLink fieldCode="AU" term="%22Joshi+M%22">Joshi M</searchLink>; Technical Operations, IDRS Labs Pvt Ltd., Bengaluru, Karnataka, 560099, India.<br /><searchLink fieldCode="AU" term="%22Udupa+V%22">Udupa V</searchLink>; Toxicology, Glenmark Pharmaceuticals Limited, Mumbai, Maharashtra, 400026, India.<br /><searchLink fieldCode="AU" term="%22Poomali+A%22">Poomali A</searchLink>; Division of Development Research, ICMR Network for Phase 1 Clinical Trials, CSTU, Indian Council of Medical Research, New Delhi, Delhi, 110029, India.<br /><searchLink fieldCode="AU" term="%22Noronha+NB%22">Noronha NB</searchLink>; Division of Development Research, ICMR Network for Phase 1 Clinical Trials, CSTU, Indian Council of Medical Research, New Delhi, Delhi, 110029, India.<br /><searchLink fieldCode="AU" term="%22Gogtay+N%22">Gogtay N</searchLink>; Department of Clinical Pharmacology, Seth GS Medical College & KEM Hospital, Mumbai, Maharashtra, 400012, India.<br /><searchLink fieldCode="AU" term="%22Krishnamurthy+MN%22">Krishnamurthy MN</searchLink>; Department of Clinical Pharmacology, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Centre, Navi Mumbai, Maharashtra, 410210, India.; Homi Bhabha National Institute (HBNI), Mumbai, Maharashtra, 400094, India.<br /><searchLink fieldCode="AU" term="%22Mohapatra+S%22">Mohapatra S</searchLink>; Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), Guwahati, Assam, 781101, India.<br /><searchLink fieldCode="AU" term="%22Saha+N%22">Saha N</searchLink>; Centre for Translational and Clinical Research, School of Chemical and Life Sciences, Jamia Hamdard, New Delhi, Delhi, 110062, India.<br /><searchLink fieldCode="AU" term="%22Gota+V%22">Gota V</searchLink>; Department of Clinical Pharmacology, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Centre, Navi Mumbai, Maharashtra, 410210, India.<br /><searchLink fieldCode="AU" term="%22Pradhan+AK%22">Pradhan AK</searchLink>; Advisor to CDSCO, New Delhi, Delhi, 110002, India.<br /><searchLink fieldCode="AU" term="%22Chatterjee+P%22">Chatterjee P</searchLink>; Cell and Gene Therapy R&D and Process Development, Aurigene Oncology Limited, Bangalore, Karnataka, 560100, India.<br /><searchLink fieldCode="AU" term="%22Kumar+A%22">Kumar A</searchLink>; Novartis Healthcare Pvt Ltd, Hyderabad, Telangana, 500081, India.<br /><searchLink fieldCode="AU" term="%22Chaturvedi+A%22">Chaturvedi A</searchLink>; CSR Delivery and Head-RWS India, Hyderabad, Telangana, 500032, India.; Regulatory Writing and Submissions (RWS), Global Clinical Operations (GCO), Novartis Healthcare Pvt Ltd., Novartis Knowledge city, Hyderabad, Telangana, 500032, India.<br /><searchLink fieldCode="AU" term="%22Balasundaram+MK%22">Balasundaram MK</searchLink>; Clinical Pharmacology Unit, Department of Pharmacology, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, 160012, India.<br /><searchLink fieldCode="AU" term="%22Prakash+G%22">Prakash G</searchLink>; Department of Clinical Haematology and Medical Oncology, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, 160012, India.<br /><searchLink fieldCode="AU" term="%22Kakkar+AK%22">Kakkar AK</searchLink>; Clinical Pharmacology Unit, Department of Pharmacology, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, 160012, India.<br /><searchLink fieldCode="AU" term="%22Malhotra+S%22">Malhotra S</searchLink>; Clinical Pharmacology Unit, Department of Pharmacology, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, 160012, India.
– Name: TitleSource
  Label: Source
  Group: Src
  Data: <searchLink fieldCode="JN" term="%229504817%22">Clinical drug investigation</searchLink> [Clin Drug Investig] 2026 Jul; Vol. 46 (7), pp. 683-689. <i>Date of Electronic Publication: </i>2026 May 26.
– Name: TypePub
  Label: Publication Type
  Group: TypPub
  Data: Journal Article; Review
– Name: TitleSource
  Label: Journal Info
  Group: Src
  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Adis%2C+Springer+International%22">Adis, Springer International </searchLink><i>Country of Publication: </i>New Zealand <i>NLM ID: </i>9504817 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1179-1918 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2211732563%22">11732563 </searchLink><i>NLM ISO Abbreviation: </i>Clin Drug Investig <i>Subsets: </i>MEDLINE
PLink https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=mdl&AN=42189405
RecordInfo BibRecord:
  BibEntity:
    Identifiers:
      – Type: doi
        Value: 10.1007/s40261-026-01558-8
    Languages:
      – Code: eng
        Text: English
    PhysicalDescription:
      Pagination:
        StartPage: 683
    Titles:
      – TitleFull: Regulatory and Ethical Frameworks for First-in-Human Clinical Trials in India: Proceedings of a Codesigned Capacity-Building Workshop.
        Type: main
  BibRelationships:
    HasContributorRelationships:
      – PersonEntity:
          Name:
            NameFull: Shafiq N
      – PersonEntity:
          Name:
            NameFull: Kumar A
      – PersonEntity:
          Name:
            NameFull: Cherian JJ
      – PersonEntity:
          Name:
            NameFull: Madan T
      – PersonEntity:
          Name:
            NameFull: Kshirsagar N
      – PersonEntity:
          Name:
            NameFull: Mukherjee A
      – PersonEntity:
          Name:
            NameFull: Vij S
      – PersonEntity:
          Name:
            NameFull: Singh PK
      – PersonEntity:
          Name:
            NameFull: Srivastava G
      – PersonEntity:
          Name:
            NameFull: Visala A
      – PersonEntity:
          Name:
            NameFull: Kumar A
      – PersonEntity:
          Name:
            NameFull: Soman A
      – PersonEntity:
          Name:
            NameFull: Kotakonda HK
      – PersonEntity:
          Name:
            NameFull: Joglekar S
      – PersonEntity:
          Name:
            NameFull: Joshi M
      – PersonEntity:
          Name:
            NameFull: Udupa V
      – PersonEntity:
          Name:
            NameFull: Poomali A
      – PersonEntity:
          Name:
            NameFull: Noronha NB
      – PersonEntity:
          Name:
            NameFull: Gogtay N
      – PersonEntity:
          Name:
            NameFull: Krishnamurthy MN
      – PersonEntity:
          Name:
            NameFull: Mohapatra S
      – PersonEntity:
          Name:
            NameFull: Saha N
      – PersonEntity:
          Name:
            NameFull: Gota V
      – PersonEntity:
          Name:
            NameFull: Pradhan AK
      – PersonEntity:
          Name:
            NameFull: Chatterjee P
      – PersonEntity:
          Name:
            NameFull: Kumar A
      – PersonEntity:
          Name:
            NameFull: Chaturvedi A
      – PersonEntity:
          Name:
            NameFull: Balasundaram MK
      – PersonEntity:
          Name:
            NameFull: Prakash G
      – PersonEntity:
          Name:
            NameFull: Kakkar AK
      – PersonEntity:
          Name:
            NameFull: Malhotra S
    IsPartOfRelationships:
      – BibEntity:
          Dates:
            – D: 01
              M: 07
              Text: 2026 Jul
              Type: published
              Y: 2026
          Identifiers:
            – Type: issn-electronic
              Value: 1179-1918
          Numbering:
            – Type: volume
              Value: 46
            – Type: issue
              Value: 7
          Titles:
            – TitleFull: Clinical drug investigation
              Type: main
ResultId 1