Bhowmik, Shravanti
Bhowmick, Subhas
Maiti, Kuntal
Chakra, Amaresh
Shahi, Pradeep
Jain, Deepak
Rajamannar, Thennati
Article History
Received: 1 March 2018
Accepted: 4 July 2018
First Online: 11 July 2018
<!--Emphasis Type='Bold' removed-->Compliance with ethical standards
:
: All authors were paid employees of Sun Pharmaceutical Industries Ltd. (SPIL) at the time the study was conducted. ShB, SB, KM, PS, and RT are shareholders in SPIL. ShB and KM are salaried employees of Sun Pharma Advanced Research Company (SPARC). KM also owns shares in SPARC.
: The studies were approved by the Drug Controller General of India and performed at three (study 1) and five (study 2) sites across India in accordance with the Guidelines for Good Clinical Practice (GCP) and the Declaration of Helsinki. The study 1 protocol and informed consent form were approved by the Institutional Ethics Committee of the MNJ Institute of Oncology and Regional Cancer Center, Hyderabad, India; the Institutional Ethics Committee of Rajah Hospital, Madurai, India; and the Institutional Ethics Committee of the Chittaranjan National Cancer Institute, Kolkata, India. The study 2 protocols and informed consent forms were approved by the Institutional Ethics Committee of the MNJ Institute of Oncology and Regional Cancer Center, Hyderabad, India; the Institutional Ethics Committee of NRR Hospital, Bangalore, Karnataka, India; the Vadodara Ethics Committee of Kailash Cancer Hospital and Research Centre, Goraj, Vadodara, India; the Medical Ethics Committee of Dr. Kamakshi Memorial Hospital, Chennai, India; and the Ethics Committee of Dr. G. Viswanathan Speciality Hospitals, Tamil Nadu, India.
: For both studies, all patients provided written informed consent before participating in the study.
: This article does not contain any studies with animals performed by any of the authors.