Regulatory and Ethical Issues in Pediatric Clinical Research: Recommendations From a Panel Discussion

Affiliations

¹ President, South Asian Affiliate of ACCP, National Chair in Clinical Pharmacology, Indian Council of Medical Research, Delhi, India.
² Indian Council of Medical Research and Department of Health Research, Delhi, India.
³ Indian Academy of Pediatrics, Mumbai, India.
⁴ New Horizons Child Developmental Center and Research Foundation, Neuro Developmental Clinic, Lokmanya Tilak, Municipal General (Sion) Hospital and Medical College, Mumbai, India.
⁵ Indian Council of Medical Research, Mumbai, India.
⁶ American College of Clinical Pharmacology, Department of Pharmaceutical Sciences, and Research and Graduate Programs, College of Pharmacy, The University of Tennessee Health Science Center, Memphis, TN, USA.
⁷ Department of Pharmacology and All India Institute of Medical Sciences, New Delhi, India.
⁸ Department of Pharmacology, PGIMER, Chandigarh, India.
⁹ Novartis Institute for Biomedical Research, Cambridge, MA, USA.
¹⁰ Joint Drugs Controller of India, Government of India, New Delhi, India.
¹¹ Serum Institute of India Pvt Ltd, Pune, India.
¹² Pediatric Therapeutic Area in Clinical Development, Novartis, Cambridge, MA, USA.
¹³ Vidhi Centre for Legal Policy, New Delhi, India.

Review

Nilima Kshirsagar et al. J Clin Pharmacol. 2017 Aug.

. 2017 Aug;57(8):943-946.

doi: 10.1002/jcph.916. Epub 2017 May 17.

¹ President, South Asian Affiliate of ACCP, National Chair in Clinical Pharmacology, Indian Council of Medical Research, Delhi, India.
² Indian Council of Medical Research and Department of Health Research, Delhi, India.
³ Indian Academy of Pediatrics, Mumbai, India.
⁴ New Horizons Child Developmental Center and Research Foundation, Neuro Developmental Clinic, Lokmanya Tilak, Municipal General (Sion) Hospital and Medical College, Mumbai, India.
⁵ Indian Council of Medical Research, Mumbai, India.
⁶ American College of Clinical Pharmacology, Department of Pharmaceutical Sciences, and Research and Graduate Programs, College of Pharmacy, The University of Tennessee Health Science Center, Memphis, TN, USA.
⁷ Department of Pharmacology and All India Institute of Medical Sciences, New Delhi, India.
⁸ Department of Pharmacology, PGIMER, Chandigarh, India.
⁹ Novartis Institute for Biomedical Research, Cambridge, MA, USA.
¹⁰ Joint Drugs Controller of India, Government of India, New Delhi, India.
¹¹ Serum Institute of India Pvt Ltd, Pune, India.
¹² Pediatric Therapeutic Area in Clinical Development, Novartis, Cambridge, MA, USA.
¹³ Vidhi Centre for Legal Policy, New Delhi, India.

No abstract available

Keywords: Clinical Pharmacology; clinical trials; drug development; ethics; pediatrics.

Publication types