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Papers by Sushma Srivastava
Therapeutic Innovation & Regulatory Science
Recombinant drug products successfully treat many life-threatening and chronic diseases. The high... more Recombinant drug products successfully treat many life-threatening and chronic diseases. The high cost of these drugs makes them inaccessible to the patients particularly in developing countries. Patent expiration of innovator recombinant drug products has led to the development of biosimilars or similar biologics by several manufacturers. Unlike generics, these are not identical to their innovator products because of the differences in the manufacturing process; however, they are similar in quality characteristics, biological activity, safety, and efficacy. The regulatory procedures used for generic drugs cannot be applied for biosimilars as they are large complex structures produced from living cells and can produce potential risk of immune-based adverse reactions. Out of several safety issues related to biosimilars, two main safety concerns are variable potency and immunogenicity, for which a robust long-term pharmacovigilance system is needed. Various guidelines have been issued...
Phytotherapy research : PTR, Jan 13, 2017
The benefits of herbal drugs were well understood way back. They have been used for the promotion... more The benefits of herbal drugs were well understood way back. They have been used for the promotion of health and medical purposes - in disease conditions. It is a conventional belief that herbal drugs have no side effects, are cheaper and locally available. Among Indian systems of medicines, herbs/herbal formulations are used to a larger extent. The quality control of the marketed herbs/herbal formulations is important for acquiring optimum therapeutic benefit as well as for expanding global outreach. Therefore, herbal drug standards are important. Reference standards, the Indian Pharmacopoeia Reference Substances especially the botanical reference substances and the phytochemical reference substances are required for comparison of quality of herbal drugs. The Indian Pharmacopoeia Commission has initiated the process of providing Indian Pharmacopoeia Reference Substances to the stakeholders. Therefore, this article provides an overview of the history and the status of herbal drug sta...
Molecular and Cellular Biochemistry, 2016
Diabetic cardiomyopathy (DCM) is a dreadful complication of diabetes responsible for 80 % mortali... more Diabetic cardiomyopathy (DCM) is a dreadful complication of diabetes responsible for 80 % mortality in diabetic patients, but unfortunately its pharmacotherapy is still incomplete. Rutin is a naturally occurring flavonoid having a long history of use in nutritional supplements for its action against oxidative stress, inflammation, and hyperglycemia, the key players involved in the progression of DCM, but remains unexplored for its role in DCM. This study was conducted to address this lacuna. It was performed in 4-week-old Streptozotocin-induced (45 mg/kg) diabetic rats for a period of 24 weeks to mimic the cardiotoxic effect of chronic hyperglycemia in diabetic patient's heart and to investigate the effect of rutin (50 mg/kg/day) in ameliorating these effects. Heart of the diabetic rats showed altered ECG parameters, reduced total antioxidant capacity, increased inflammatory assault, and degenerative changes. Interestingly, rutin treatment significantly ameliorated these changes with decrease in blood glucose level (p > 0.001), % HbA1c (p > 0.001) and reduced expression of TNF-α (p < 0.001), CRP (p < 0.001), and BNP (p < 0.01) compared to diabetic control rats. In addition, rutin provided significant protection against diabetes associated oxidative stress (p < 0.05), prevented degenerative changes in heart, and improved ECG parameters compared to diabetic control rats. The heart-to-body weight ratio was significantly reduced in rutin treatment group compared to diabetic control rats (p < 0.001). In conclusion, this study implicates that oxidative stress and inflammation are the central players involved in the progression of DCM and rutin ameliorates DCM through its antioxidant and anti-inflammatory actions on heart.
Meth Find Exp Clin Pharmacol, 2007
Estimation of intraocular pressure in rabbits is often done by indentation tonometry using Schiot... more Estimation of intraocular pressure in rabbits is often done by indentation tonometry using Schiotz tonometer. The use of Schiotz tonometer for estimation of intraocular pressure requires the use of topical anesthesia, poses risk of infection and injury to cornea and puts the animal under stress. Therefore, in this study noncontact tonometer was used to estimate intraocular pressure in rabbits and the technique is described for the first time. Twenty-five rabbits were subjected to intraocular pressure estimation using Schiotz as well as noncontact tonometer by two independent observers. All intraobserver and interobserver differences were within two standard deviation from the mean, indicating good repeatability and reproducibility of the two methods. A good linear correlation was observed between measurements done by Schiotz and noncontact tonometers with the correlation coefficient (r(2)) of 0.9122 and regression equation y = 1.632x + 4.8684. No significant difference was observed in percent change in intraocular pressure in timolol-treated, water-loaded rabbits using noncontact tonometer and Schiotz tonometer. Noncontact tonometer provides an easy, quick and safe method for intraocular pressure estimation, which is comparable to the conventional method of Schiotz tonometry. Therefore, despite the cost, noncontact tonometry seems to have a greater scope in experimental studies.
Molecular vision, 2016
Diabetic retinopathy is a common microvascular complication of long-standing diabetes. Several co... more Diabetic retinopathy is a common microvascular complication of long-standing diabetes. Several complex interconnecting biochemical pathways are activated in response to hyperglycemia. These pathways culminate into proinflammatory and angiogenic effects that bring about structural and functional damage to the retinal vasculature. Since Zingiber officinale (ginger) is known for its anti-inflammatory and antiangiogenic properties, we investigated the effects of its extract standardized to 5% 6-gingerol, the major active constituent of ginger, in attenuating retinal microvascular changes in rats with streptozotocin-induced diabetes. Diabetic rats were treated orally with the vehicle or the ginger extract (75 mg/kg/day) over a period of 24 weeks along with regular monitoring of bodyweight and blood glucose and weekly fundus photography. At the end of the 24-week treatment, the retinas were isolated for histopathological examination under a light microscope, transmission electron microsco...
Indian Journal of Experimental Biology, Oct 1, 2013
Aqueous extract of C. longa when administered 4 h after induction of E. coli lipopolysaccharide-i... more Aqueous extract of C. longa when administered 4 h after induction of E. coli lipopolysaccharide-induced uveitis in rats showed significantly suppressed inflammation with a significantly lower mean clinical grade, histopathological grade and aqueous humor (AH) protein level compared to vehicle treated group. Although, prednisolone group showed significantly lower clinical grade, histopathological grades and AH protein levels compared to C. longa group, TNF-alpha levels did not differ significantly. Moreover, when the aqueous extract was administered starting from 3 days before induction of uveitis, the mean clinical and histopathological grade as well as AH protein and TNF-alpha levels were comparable to C. longa group when treatment was administered 4 h after induction of uveitis. It is concluded that topically applied standardized aqueous extract of C. longa suppresses endotoxin-induced uveitis in rats by reducing TNF-alpha activity.
Drug Screening Methods, 2016
Drug Screening Methods, 2016
Drug Discovery and Clinical Research, 2011
Textbook of Pharmacovigilance, 2011
Acta Ophthalmologica Scandinavica, 2003
Drug Screening Methods, 2016
Drug Screening Methods, 2016
Drug Screening Methods, 2016
Therapeutic Innovation & Regulatory Science
Recombinant drug products successfully treat many life-threatening and chronic diseases. The high... more Recombinant drug products successfully treat many life-threatening and chronic diseases. The high cost of these drugs makes them inaccessible to the patients particularly in developing countries. Patent expiration of innovator recombinant drug products has led to the development of biosimilars or similar biologics by several manufacturers. Unlike generics, these are not identical to their innovator products because of the differences in the manufacturing process; however, they are similar in quality characteristics, biological activity, safety, and efficacy. The regulatory procedures used for generic drugs cannot be applied for biosimilars as they are large complex structures produced from living cells and can produce potential risk of immune-based adverse reactions. Out of several safety issues related to biosimilars, two main safety concerns are variable potency and immunogenicity, for which a robust long-term pharmacovigilance system is needed. Various guidelines have been issued...
Phytotherapy research : PTR, Jan 13, 2017
The benefits of herbal drugs were well understood way back. They have been used for the promotion... more The benefits of herbal drugs were well understood way back. They have been used for the promotion of health and medical purposes - in disease conditions. It is a conventional belief that herbal drugs have no side effects, are cheaper and locally available. Among Indian systems of medicines, herbs/herbal formulations are used to a larger extent. The quality control of the marketed herbs/herbal formulations is important for acquiring optimum therapeutic benefit as well as for expanding global outreach. Therefore, herbal drug standards are important. Reference standards, the Indian Pharmacopoeia Reference Substances especially the botanical reference substances and the phytochemical reference substances are required for comparison of quality of herbal drugs. The Indian Pharmacopoeia Commission has initiated the process of providing Indian Pharmacopoeia Reference Substances to the stakeholders. Therefore, this article provides an overview of the history and the status of herbal drug sta...
Molecular and Cellular Biochemistry, 2016
Diabetic cardiomyopathy (DCM) is a dreadful complication of diabetes responsible for 80 % mortali... more Diabetic cardiomyopathy (DCM) is a dreadful complication of diabetes responsible for 80 % mortality in diabetic patients, but unfortunately its pharmacotherapy is still incomplete. Rutin is a naturally occurring flavonoid having a long history of use in nutritional supplements for its action against oxidative stress, inflammation, and hyperglycemia, the key players involved in the progression of DCM, but remains unexplored for its role in DCM. This study was conducted to address this lacuna. It was performed in 4-week-old Streptozotocin-induced (45 mg/kg) diabetic rats for a period of 24 weeks to mimic the cardiotoxic effect of chronic hyperglycemia in diabetic patient's heart and to investigate the effect of rutin (50 mg/kg/day) in ameliorating these effects. Heart of the diabetic rats showed altered ECG parameters, reduced total antioxidant capacity, increased inflammatory assault, and degenerative changes. Interestingly, rutin treatment significantly ameliorated these changes with decrease in blood glucose level (p > 0.001), % HbA1c (p > 0.001) and reduced expression of TNF-α (p < 0.001), CRP (p < 0.001), and BNP (p < 0.01) compared to diabetic control rats. In addition, rutin provided significant protection against diabetes associated oxidative stress (p < 0.05), prevented degenerative changes in heart, and improved ECG parameters compared to diabetic control rats. The heart-to-body weight ratio was significantly reduced in rutin treatment group compared to diabetic control rats (p < 0.001). In conclusion, this study implicates that oxidative stress and inflammation are the central players involved in the progression of DCM and rutin ameliorates DCM through its antioxidant and anti-inflammatory actions on heart.
Meth Find Exp Clin Pharmacol, 2007
Estimation of intraocular pressure in rabbits is often done by indentation tonometry using Schiot... more Estimation of intraocular pressure in rabbits is often done by indentation tonometry using Schiotz tonometer. The use of Schiotz tonometer for estimation of intraocular pressure requires the use of topical anesthesia, poses risk of infection and injury to cornea and puts the animal under stress. Therefore, in this study noncontact tonometer was used to estimate intraocular pressure in rabbits and the technique is described for the first time. Twenty-five rabbits were subjected to intraocular pressure estimation using Schiotz as well as noncontact tonometer by two independent observers. All intraobserver and interobserver differences were within two standard deviation from the mean, indicating good repeatability and reproducibility of the two methods. A good linear correlation was observed between measurements done by Schiotz and noncontact tonometers with the correlation coefficient (r(2)) of 0.9122 and regression equation y = 1.632x + 4.8684. No significant difference was observed in percent change in intraocular pressure in timolol-treated, water-loaded rabbits using noncontact tonometer and Schiotz tonometer. Noncontact tonometer provides an easy, quick and safe method for intraocular pressure estimation, which is comparable to the conventional method of Schiotz tonometry. Therefore, despite the cost, noncontact tonometry seems to have a greater scope in experimental studies.
Molecular vision, 2016
Diabetic retinopathy is a common microvascular complication of long-standing diabetes. Several co... more Diabetic retinopathy is a common microvascular complication of long-standing diabetes. Several complex interconnecting biochemical pathways are activated in response to hyperglycemia. These pathways culminate into proinflammatory and angiogenic effects that bring about structural and functional damage to the retinal vasculature. Since Zingiber officinale (ginger) is known for its anti-inflammatory and antiangiogenic properties, we investigated the effects of its extract standardized to 5% 6-gingerol, the major active constituent of ginger, in attenuating retinal microvascular changes in rats with streptozotocin-induced diabetes. Diabetic rats were treated orally with the vehicle or the ginger extract (75 mg/kg/day) over a period of 24 weeks along with regular monitoring of bodyweight and blood glucose and weekly fundus photography. At the end of the 24-week treatment, the retinas were isolated for histopathological examination under a light microscope, transmission electron microsco...
Indian Journal of Experimental Biology, Oct 1, 2013
Aqueous extract of C. longa when administered 4 h after induction of E. coli lipopolysaccharide-i... more Aqueous extract of C. longa when administered 4 h after induction of E. coli lipopolysaccharide-induced uveitis in rats showed significantly suppressed inflammation with a significantly lower mean clinical grade, histopathological grade and aqueous humor (AH) protein level compared to vehicle treated group. Although, prednisolone group showed significantly lower clinical grade, histopathological grades and AH protein levels compared to C. longa group, TNF-alpha levels did not differ significantly. Moreover, when the aqueous extract was administered starting from 3 days before induction of uveitis, the mean clinical and histopathological grade as well as AH protein and TNF-alpha levels were comparable to C. longa group when treatment was administered 4 h after induction of uveitis. It is concluded that topically applied standardized aqueous extract of C. longa suppresses endotoxin-induced uveitis in rats by reducing TNF-alpha activity.
Drug Screening Methods, 2016
Drug Screening Methods, 2016
Drug Discovery and Clinical Research, 2011
Textbook of Pharmacovigilance, 2011
Acta Ophthalmologica Scandinavica, 2003
Drug Screening Methods, 2016
Drug Screening Methods, 2016
Drug Screening Methods, 2016