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Sharma, Sandeep
- Intricacies in the Approval of Radiopharmaceuticals – Regulatory Perspectives and the Way Forward
Abstract Views :253 |
PDF Views:68
Authors
Affiliations
1 I. K. Gujral Punjab Technical University, Jalandhar - 144 603, IN
2 National Institute of Pharmaceutical Education and Research, SAS Nagar - 160 062, IN
3 Maharaja Ranjit Singh Punjab Technical University, Bathinda - 151 001, IN
4 Shivalik College of Pharmacy, Nangal, Rupnagar - 140 126, IN
5 Defence Food Research Laboratory, Siddartha Nagar, Mysuru - 570 011, IN
1 I. K. Gujral Punjab Technical University, Jalandhar - 144 603, IN
2 National Institute of Pharmaceutical Education and Research, SAS Nagar - 160 062, IN
3 Maharaja Ranjit Singh Punjab Technical University, Bathinda - 151 001, IN
4 Shivalik College of Pharmacy, Nangal, Rupnagar - 140 126, IN
5 Defence Food Research Laboratory, Siddartha Nagar, Mysuru - 570 011, IN
Source
Current Science, Vol 116, No 1 (2019), Pagination: 47-55Abstract
Extensive research by the global scientific fraternity has led to the production of many radiopharmaceuticals of immense clinical importance. However, this increasing availability has not been matched by adequate regulatory action to back up the legal foundation for their commercial use. It is imperative for a radiopharmaceutical to have a seal of regulatory authority approval to qualify for human use. The present article highlights various regulatory requirements for approval of radio-pharmaceuticals in USA, Europe, and particularly India, which does not have guidelines for their approval, and intensifies the concern for a harmonized regulatory platform of global acceptance.Keywords
Approval, Commercial Use, Guidelines, Radiopharmaceuticals, Regulatory Authority.Full Text
References
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- The Regulatory Dilemma for Import of Radiopharmaceuticals in India
Abstract Views :255 |
PDF Views:74
Authors
Affiliations
1 I.K. Gujral Punjab Technical University, Jalandhar 144 603, IN
2 Raja Ramanna Fellow, BARC, Radiation Medicine Centre and BRIT, Mumbai 400 012, IN
3 Maharaja Ranjit Singh Punjab Technical University, Bathinda 151 001, IN
4 Shivalik College of Pharmacy, Nangal, District Rupnagar 140 126,, IN
5 Saveetha Institute of Medical and Technical Sciences, Chennai 602 105, IN
1 I.K. Gujral Punjab Technical University, Jalandhar 144 603, IN
2 Raja Ramanna Fellow, BARC, Radiation Medicine Centre and BRIT, Mumbai 400 012, IN
3 Maharaja Ranjit Singh Punjab Technical University, Bathinda 151 001, IN
4 Shivalik College of Pharmacy, Nangal, District Rupnagar 140 126,, IN
5 Saveetha Institute of Medical and Technical Sciences, Chennai 602 105, IN
Source
Current Science, Vol 116, No 11 (2019), Pagination: 1787-1789Abstract
The inclusion of monographs of several radiopharmaceuticals in the Indian Pharmacopoeia has drawn the attention of drug control authorities in the country and other stakeholders. Therefore, in a move towards better regulation of radiopharmaceuticals, the Office of the Drug Controller General of India has issued some important notices concerning their import. However, these notices have resulted in several misgivings among the nuclear medicine community as appointment of patients for nuclear medicine scans had to be cancelled/rescheduled and clinical decisions delayed. An analysis of the sequence of events is presented in this study, highlighting the effects of decisions taken regarding import of radiopharmaceuticals, and suggestions to implement regulations with minimal repercussions.Full Text
References
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- Assessing Extracellular Enzymatic Activity in the Soil on Addition of Root Biomass with Different Biochemical Composition
Abstract Views :231 |
PDF Views:83
Authors
Affiliations
1 Department of Soil Science, Punjab Agricultural University, Ludhiana 141 004, IN
2 Department of Microbiology, Punjab Agricultural University, Ludhiana 141 004, IN
1 Department of Soil Science, Punjab Agricultural University, Ludhiana 141 004, IN
2 Department of Microbiology, Punjab Agricultural University, Ludhiana 141 004, IN
Source
Current Science, Vol 119, No 11 (2020), Pagination: 1807-1814Abstract
Biochemical quality of a biomass determines the rate of its decomposition, which ultimately affects the relative microbial communities. Root biomass constitutes a significant fraction of total plant biomass and can play an important role in affecting microbial activity and extracellular soil enzymes when ischolar_mains have different biochemical composition. To address the pivotal action of biochemical quality, a short-term incubation study was carried out to determine the effect of heterogeneity of ischolar_main biomass on the functional characteristics of enzyme activities in the soil. Root biomasses of six crops with contrasting chemical composition (Oryza sativa, Zea mays, Gossypium hirsutum, Glycine max, Cajanus cajan and Sesamum indicum) were applied alone as well as in different combinations to a sandy-loam soil incubated under controlled environment condition for 63 days. The enzyme activity peaked on the 42nd day, which ranged from 11.85 to 16.85 μg triphenylformazan and from 9.84 to 13.67 μg p-nitrophenol g–1 h–1 for dehydrogenase and alkaline phosphatase respectively. Among the different ischolar_main biomasses and their combinations, maximum soil enzyme activity was found for Z. mays (T2) followed by G. max (T4) and G. max + O. sativa (T9). The ischolar_mains of Oryza sativa (T3), Cajanus cajan (T6) and Cajanus cajan + Oryza sativa (T10) with high contents of hemicellulose and low contents of cellulose showed low enzymatic activity. Cellulose and hemicellulose contents in ischolar_main biomass are mainly responsible for the enhanced functional diversity of soil microbial communities as well as enzyme activities.Keywords
Biochemical Composition, Enzymatic Activity, Root Biomass, Soil Microbial Communities.Full Text