In User: Drkrishnasarmapathy

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Name: Drkrishnasarmapathy

Joined: Tuesday 24 July 2012 08:13:50 (UTC)

Last seen: Wednesday 11 May 2022 06:13:28 (UTC)

Email (public): drkrishnasarmapathy

Website: http://www.linkedin.com/profile/view?id=59539573&trk=tab_pro

Location: lucknow, India

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To carry out  Quality assurance  and development activity in the field of Organic Chemistry, to make profit for the organization, motivate, guide & lead a team of scientists, Direct strategic planning and the development of goals allied with organization objectives for the Quality group. Ensure the development of talent for leadership roles and plan talent succession for Quality Specialty Operations. Key focuses on maintaining State Of Control, Quality, Compliance, robust and efficient service level and continues improvement.Recommend actions or policies that result in quality operational sites enhancements for compliance and inspection readiness, ensure that critical or strategic priorities at the regional sites are adhering to global quality policies and that sufficient quality oversight is demonstrated in all operational deliverables. Acting as Quality Program Lead for assigning projects to ensure appropriate quality of development and production within defined timelines. Representing Quality Operations in cross-functional project teams with responsibility for oversight of the overall quality of the project .Co-ordinate with inter department functions and manufacturing site functions for technical evaluations and review wherever required.
Assure the cross regional systems implementations are integrated and provide the highest level of efficiency. This includes Laboratory Process optimization, Operational Excellence, analytical excellence, compliance level setting and Global Strategic IT implementations (LIMS, TrackWise, Documentum and other GMP system etc.). Up date knowledge and understanding of worldwide requirements of cGMP and Quality Systems for Commercial products.Hands-on expertise in highest quality standards, GMP compliance and build a quality orientated culture.and worked in regulated plants having approvals of US FDA, MHRA.etc.Hands-on experience in successfully handling and implementing cGMP (Current Good Manufacturing Practice) practices, quality management system, risk assessment, mitigation and Good Documentation Practices


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Interests:

: To carry out research and development activity in the field of Organic Chemistry, to make profit for the organization, motivate, guide & lead a team of scientists, conduct literature search, identify and execute new/novel routes for the synthesis, scale up from grams to kilo levels in lab., conduct pilot trials and assist in production upto ton levels. Carry out impurity profiles and assist in dossier writing. All the above being done keeping in mind the regulatory, safety, environmental issues. To keep in mind IPR issues and draft patents , Commercial aspects taken care are the time schedules, quality parameters and cost factors. All this with a view of non infringement and confidentiality. Simultaneously develop business acumen and convert to profits.file DMFS in US and EU, file patents and contribute to intellectual property

Field/Industry: CHEMICAL/PHARMA

Occupation/Role(s): HEAD

Organisation(s):

IPL LTD

 

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Blob Antiviral Drugs in the battle against COVID-19 & Min...

Created: 2022-02-02 07:17:26

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Patent Evaluation of Antiviral Drugs in the battle against COVID-19 &Minimization of Risks Associated with Occurrence of Dangerousviral mutations During Treatment with Antiviral Mutagenic Agents 

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Blob International Journal of Research Studies in Medical...

Created: 2020-08-21 11:22:57

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Abstract – Hydroquinone as a volatile aromatic hydrocarbon; There is a huge confusion in the public, as well as among politicians and even some scientists, about those two molecules. That confusion ultimately led to people accidently overdosing. Both molecules can be classified as 4-aminoquinolines, and both have anti-plasmodial activities, but they remain two different molecules with some different metabolites. Chloroquine has been widely used since the 1950s for prophylactic and ...

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Blob Antiviral nucleosides- Flu Viruses- QUINOLINES-COV...

Created: 2020-08-21 10:58:20 | Last updated: 2020-08-21 10:58:52

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Antiviral nucleosides-  Flu Viruses-                QUINOLINES-COVID-19 Hydroquinone as a volatile aromatic hydrocarbon; There is a huge confusion in the public, as well as among politicians and even some scientists, about those two molecules. That confusion ultimately led to people accidently overdosing. Both molecules can be classified as 4-aminoquinolines, and both have anti-plasmodial activities, but they...

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Blob HCV NS3/4A 3 Protease Inhibitors: Simeprevir, Proces...

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In polymerase and protease drug targets and drug development, which has resulted in a strong infectious disease R&D portfolio,”and has given the company its key pipeline asset, simeprevir (TMC435), a novel protease inhibitor in Phase III clinicaldevelopment for hepatitis C that is being developed in collaboration with Janssen Pharmaceuticals. Currently, hepatitis C virus(HCV) infection is considered a serious health-care problem all over the world. A good number of direct-acting ant...

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Blob Chronic Hepatitis (Chc), Viral Polymerase Nucleotide...

Created: 2019-10-12 11:22:31

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Sofosbuvir is a viral polymerase nucleotide inhibitor that was approved in December2013 by the United States Food and Drug Administration (FDA), and in January 2014by the European Medicines Agency for the treatment of HCV infection [1]. The WHOGuidelines for the screening, care and treatment of persons with hepatitis C infectionrecommend sofosbuvir in combination with ribavirin in genotypes 1, 2, 3 and 4 HCVinfection, either with or without pegylated interferon (depending on the HCV genotype)...

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Blob Bempedoic Acid a Small Molecule Drug Process and Syn...

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Low Density Lipoprotein Cholesterol AbstractBempedoic acid (ETC-1002), a small molecule drug, promotes low density lipoprotein (LDL) receptor mediated clearanceof LDL-cholesterol (LDL-C) by inhibition of adenosine triphosphate citrate lyase (ACL), a mechanism complementary to thoseof existing lipid-modifying therapies. Bempedoic acid is a pro-drug activated specifically within the liver where it inhibits ACL,a regulatory checkpoint within the cholesterol biosynthesis pathway. By inhibiti...

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Blob Crystallization and Polymorphism-Scalable Process fo...

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Crystallization and Polymorphism-Scalable Process for Celecoxib and It’s Polymorph From-3

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Blob Citation: Krishnasarma P, MS Chakravarthy. Crystalli...

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Citation: Krishnasarma P, MS Chakravarthy. Crystallization and Polymorphism-Scalable Process for Celecoxib and It’s Polymorph From-3(Non- Steroidal Anti-Inflammatory Drug (NSAID). LOJ Med Sci 2(2)-2018. LOJMS.MS.ID.000134. 125Review ArticleCrystallization and Polymorphism-Scalable Process forCelecoxib and It’s Polymorph From-3 (Non- SteroidalAnti-Inflammatory Drug (NSAID) 

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Blob Cefpodoxime Proxetil and its By-Products: A Comparat...

Created: 2018-08-31 07:40:48

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Cefpodoxime Proxetil and its By-Products: A Comparative Study as Per EP-7 Krishnasarma pathy*LOJ Med Sci 

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Blob Biomedical Journal of Scientific & Technical Research.

Created: 2018-08-31 06:24:53

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Considerations for Successful Scale-Up to Tox Batches and Phase-Api (Bulk Drug substance)[*]       Krishnasarma pathy* DOI : 10.26717/BJSTR.2018.08.001662Biomedical Journal of Scientific & Technical Research.

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Blob Biomedical Journal of Scientific & Technical Researc...

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Considerations for Successful Scale-Up to Tox Batches and Phase-Api (Bulk Drug substance)[*]       Krishnasarma pathy* DOI : 10.26717/BJSTR.2018.08.001662Biomedical Journal of Scientific & Technical Research.

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Blob Case History-The Control of Impurities-A Critical Is...

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Case History-The Control of Impurities-A CriticalIssue to The Active Pharmaceutical Ingredient 

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Blob Case History-The Control of Impurities-A Critical Is...

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Case History-The Control of Impurities-A CriticalIssue to The Active Pharmaceutical Ingredient 

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Blob Herald Scholarly Open Access Pathy K (2018) Entecavi...

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Herald Scholarly Open Access  krishnasarma Pathy K (2018) Entecavir Patent Evaluation & Genotoxicity.pdf

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Blob Herald Scholarly Open Accesskrishnasarma Pathy K (20...

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Herald Scholarly Open Accesskrishnasarma Pathy K (2018) Entecavir Patent Evaluation & Genotoxicity.

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Blob Krishnasarma Pathy (2018) Process for Preparation of...

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Krishnasarma Pathy (2018) Process for Preparation of Vitamin C and Method for Determination of Vitamin C in Tablets. SF J Chem Res 2:1.

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Blob Method for Preparation of Vitamin C and Method for D...

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Procedure for calcium ascorbate (VITAMIN-C) includes such technological steps as reaction of ascorbic acidon calcium carbonate in water in recent years; the determination of vitamin C has become an important subject in the fieldof biochemistry and commercial foods. This is because vitamin C plays an important role in maintaining human health.Due to the importance of vitamin C in human beings, the quantitative analysis of vitamin C has gained a significantincrease in several areas of analytica...

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Blob Entecavir Patent Evaluation, Method for Diastereomer...

Created: 2018-06-29 10:47:08 | Last updated: 2018-06-29 10:48:15

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Entecavir Patent Evaluation, Method for Diastereomeric ImpuritiesEntecavir is an oral antiviral drug used in the treatment of hepatitis B infection. Entecavir is a guanosine nucleoside analogue with selective activity against hepatitis B virus (HBV), which inhibits reverse transcription, The initial patent on entecavir expired in South Africa in 2011 ZA 1991/07894. Current status available on: http://patentsearch.cipc.co.za/, which should have permitted lower-cost generic competitors to enter...

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Blob Organic and Medicinal Chemistry International Journa...

Created: 2018-06-29 10:43:43

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Organic and Medicinal Chemistry International Journal:Entecavir Patent Evaluation, Method for Diastereomeric ImpuritiesEntecavir is an oral antiviral drug used in the treatment of hepatitis B infection. Entecavir is a guanosine nucleoside analogue with selective activity against hepatitis B virus (HBV), which inhibits reverse transcription, The initial patent on entecavir expired in South Africa in 2011 ZA 1991/07894. Current status available on: http://patentsearch.cipc.co.za/, which should ...

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Blob krishnasarmapathy-Entecavir Patent Evaluation, Molec...

Created: 2018-06-21 05:38:08

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Entecavir is an oral antiviral drug used in the treatment of hepatitis B infection. Entecavir is a guanosine nucleoside analogue with selective activity against hepatitis B virus (HBV), which inhibits reverse transcription, Hepatitis B virus (HBV) is highly endemic in South Africa and across sub-Saharan Africa, where around 8% of people are chronically infected, and rates of HBV-related liver cancer are some of the highest in the world. Globally, viral hepatitis causes approximately 1.3 milli...

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Blob Entecavir Patent Evaluation, Molecular Modelling Stu...

Created: 2018-06-21 05:36:07

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Entecavir is an oral antiviral drug used in the treatment of hepatitis B infection. Entecavir is a guanosine nucleoside analogue with selective activity against hepatitis B virus (HBV), which inhibits reverse transcription, Hepatitis B virus (HBV) is highly endemic in South Africa and across sub-Saharan Africa, where around 8% of people are chronically infected, and rates of HBV-related liver cancer are some of the highest in the world. Globally, viral hepatitis causes approximately 1.3 milli...

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Blob Process for Preparation of Vitamin C and Method for ...

Created: 2018-06-19 06:44:55

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Process for Preparation of Vitamin C and Method for Determination of Vitamin C in Tablets

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Blob Process for Preparation of Vitamin C and Method for ...

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Process for Preparation of Vitamin C and Method for Determination of Vitamin C in Tablets

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Blob SCHOLARLY JOURNAL OF FOOD AND NUTRITION-Route Evalua...

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This is out line work on the process development for the synthesis of buprenorphine, naltrexone, naloxone, and nalbuphine from naturally occurring opiates such as Thebaine, also known as codeine methyl enol ether, and oripavine. Several new methods for N-demethylation of morphinans have been developed during the pursuit of this research. The article traces the evolution of various approaches and provides a comparison for overall efficiency. A reverse phase high performance liquid chromatograp...

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Blob Route Evaluation and Analytical HPLC Method Developm...

Created: 2018-06-04 05:30:06 | Last updated: 2018-06-04 05:30:26

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This is out line work on the process development for the synthesis of buprenorphine, naltrexone, naloxone, and nalbuphine from naturally occurring opiates such as Thebaine, also known as codeine methyl enol ether, and oripavine. Several new methods for N-demethylation of morphinans have been developed during the pursuit of this research. The article traces the evolution of various approaches and provides a comparison for overall efficiency. A reverse phase high performance liquid chromatograp...

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Blob process development of antiviral agents : Amantadin...

Created: 2018-05-05 07:09:19

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Recent advances in process development of antiviral agents targeting the influenza virus: Amantadine-Remantadine-derived pharmaceutical agents"

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Blob Recent advances in process development of antiviral ...

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Recent advances in process development of antiviral agents targeting the influenza virus: Amantadine-Remantadine-derived pharmaceutical agents"

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Blob IJMSCI Recent advances in process development of ant...

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Recent advances in process development of antiviral agents targeting the influenza virus: Amantadine-Remantadine-derived pharmaceutical agents"

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Blob Bigunidine Metformin Pharmacologically Efficacious T...

Created: 2018-03-23 07:50:58

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Metformin usage may be considered for people with type 2 diabetes to help them control their blood sugar levels a secondary sideeffect may be weight loss, which leads some to believe it may be a viable medication to use for weight loss. However, researchers arestill not clear on whether or not metformin has an actual impact on weight, or if weight loss is due to lifestyle changes in people withtype 2 diabetes. Metformin (Glucophage, Glumetza, Fortamet) is typically prescribed to counteract th...

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Blob Bigunidine Metformin Pharmacologically Efficacious T...

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Metformin usage may be considered for people with type 2 diabetes to help them control their blood sugar levels a secondary sideeffect may be weight loss, which leads some to believe it may be a viable medication to use for weight loss. However, researchers arestill not clear on whether or not metformin has an actual impact on weight, or if weight loss is due to lifestyle changes in people withtype 2 diabetes. Metformin (Glucophage, Glumetza, Fortamet) is typically prescribed to counteract th...

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Blob Synthesis of Sildenafil Citrate Validated HPLC Metho...

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The present study describes analytical method of 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H–pyrazolo[4,3-d]pyrimidin-5-yl)-4- ethoxyphenyl]sulphonyl]-4methypiperazine citrate (sildenafil Citrate). The following specification particularly describes and ascertains the nature of this invention, and the manner in which it is to be performed. Sildenafil is an oral drug used primarily to treat male sexual function problems (impotence or erectile dysfunction) since becoming available in 199...

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Blob Synthesis of Sildenafil Citrate Validated HPLC Metho...

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The present study describes analytical method of 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H–pyrazolo[4,3-d]pyrimidin-5-yl)-4- ethoxyphenyl]sulphonyl]-4methypiperazine citrate (sildenafil Citrate). The following specification particularly describes and ascertains the nature of this invention, and the manner in which it is to be performed. Sildenafil is an oral drug used primarily to treat male sexual function problems (impotence or erectile dysfunction) since becoming available in 199...

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Blob Antihistamine Drugs Possess some Antiacetylcholine P...

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Antihistamine Drugs Possess someAntiacetylcholine Properties 

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Blob Epidemic Flu Viruses & the influenza a virus

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Epidemic Flu Viruses & the influenza a virus

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Blob Nutri Food Sci Int J 5(5): NFSIJ.MS.ID.555674 (2018)...

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Nutri Food Sci Int J 5(5): NFSIJ.MS.ID.555674 (2018) 001

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Blob Krishnasarma Pathy* DOI: 10.19080/OAJT.2018.02.55559...

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Epidemic Flu Viruses & the influenza a virus subtypes H1N1, H1N2 and H3N2, HDFxKrishnasarma Pathy*Head of QC/QA, IPL Research Centre, IndiaSubmission: October 31, 2017; Published: March 07, 2018*Corresponding author: Krishnasarma Pathy, Head of QC/QA, IPL Research Centre, India, Tel: 9919188895,Email:Open Acc J of Toxicol. 2018; 2(4): OAJT.MS.ID.555593 (2018)001Mini ReviewThe history of flu viruses teaches that the influence has origin from animal’s birds, generically aquatic, and t...

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Blob Krishnasarma Pathy*Flu Viruses Open Acc J of Toxicol...

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Krishnasarma Pathy*Head of QC/QA, IPL Research Centre, IndiaSubmission: October 24, 2017; Published: March 07, 2018*Corresponding author: Krishnasarma Pathy, Head of QC/QA, IPL Research Centre, India, Tel: 9919188895Human H1N1 pandemic developed from the originally localized Mexican source early in the spring 2009. For the emergency created by the epidemic of influence of the pigs in Mexico it was correct not to create alarmism being victims of bad information. Cytokine storm should be mentio...

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Blob Abstract Human H1N1 pandemic developed from the orig...

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For the emergency created by the epidemic of influence of the pigs in Mexico it was correct not to create alarmisms being victims of a bad information. The possibility that the virus arrives in other parts of the world is real as for all the types of influence virus. In order that a strain has a wide distribution, its antigenic characteristics must ensure that it escapes the neutralization of antibodies of the host and of the surrounding population. The discovery of a new, biologic Host-Defen...

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Blob FLUVIRUSES

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AbstractHuman H1N1 pandemic developed from the originally localized Mexican source early in the spring 2009. For the emergency created by the epidemic of influence of the pigs in Mexico it was correct not to create alarmism being victims of bad information. Cytokine storm should be mentioned as one of the key pathogenic events contributing to the overall mortality in substantial portion of patients. If active immunization is assumed to be preventive measure of proven efficacy, clinicians are ...

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Blob Title (-)-Galantamine Pharmacological screening and...

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Blob http://scifed.com/fulltext/the-influenza-a-virus-sub...

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http://scifed.com/fulltext/the-influenza-a-virus-subtypes-h1n1-h1n2-and-h3n2-hdfx-a-novel-immunomodulatorand-potential-fighter-against-cytokine-storms-in-viral-flu-infections-carica-papaya-linn/21844#one

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http://scifed.com/fulltext/the-influenza-a-virus-subtypes-h1n1-h1n2-and-h3n2-hdfx-a-novel-immunomodulatorand-potential-fighter-against-cytokine-storms-in-viral-flu-infections-carica-papaya-linn/21844#one

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Blob Krishnasarma pathy, (2017) The influenza A virus sub...

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The discovery of a new, biologic host-defense protein, “HDFx”, may provide a unique way to ameliorate and prevent the “cytokinestorms” and haemorrhages seen in severe influenza infections.The influenza A virus subtypes H1N1, H1N2 and H3N2 are prevalent inpig populations worldwide. All scientific data point towards swine as the key host species for new human influenza pandemics, whichhave been suggested to evolve in pigs from viral genes of avian, human and porcine orig...

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Blob Krishnasarma pathy, (2017) The influenza A virus sub...

Created: 2017-11-20 11:10:20

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The discovery of a new, biologic host-defense protein, “HDFx”, may provide a unique way to ameliorate and prevent the “cytokinestorms” and haemorrhages seen in severe influenza infections.The influenza A virus subtypes H1N1, H1N2 and H3N2 are prevalent inpig populations worldwide. All scientific data point towards swine as the key host species for new human influenza pandemics, whichhave been suggested to evolve in pigs from viral genes of avian, human and porcine orig...

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Blob The influenza A virus subtypes H1N1, H1N2 and H3N2 ,...

Created: 2017-11-16 12:21:14

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The influenza A virus subtypes H1N1, H1N2 and H3N2 ,HDFx: A NovelImmunomodulator and Potential Fighter Against Cytokine Storms inViral Flu Infections- Carica papaya Linn 

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Blob Method Development and Pharmacological study of Chem...

Created: 2017-08-18 10:18:59

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Blob Oxcarbazepine by HPLC Method

Created: 2017-04-12 10:18:08

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~Oxcarbazepine is in a class of drug called anticonvulsants. It inhibits unusual electrical activity in the brain. Oxcarbazepine may help control seizures, but it does not cure the disease. However, this medication is also used for treatment of epilepsy. Oxcarbazepine HPLC chromatography determination method was developed to quantify the quality of the synthesized drug. The developed method was then validated for the determination of Oxcarbazepine The separation was achieved in a octylsilyl s...

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Blob 5 Batch Analysis,Guidance to the manufacturer and th...

Created: 2016-09-10 09:21:16

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~~The term ‘5 – batch analysis’ originates from the US EPA guidelines for testing of pesticides. The term is accepted now by most regulatory bodies like EEC, Indian registration authorities namely CIB & RC and other countries as well. There are no guidelines of OECD for this study. The study is essential to determine the composition of the product with respect to the active ingredient and its associated impurities.

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Blob SILDENAFIL CITRATE (Viagra) IN ITS POLYMORPHIC FORMS

Created: 2013-04-08 05:17:04

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 AN IMPROVED PROCESS FOR THE PREPARATION OF SILDENAFIL CITRATE (Viagra) IN ITS POLYMORPHIC FORM The present invention provides an improved process for preparation of 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H –pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulphonyl]-4methypiperazine citrate (Sildenafil Citrate) ofPolymorphic form I)

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Blob synnthesis of Tris[ 2-pyridyl)methyl]amine

Created: 2012-09-14 09:57:46

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Blob STUDY OF QUANTIFICATION OF IMPURITIES AND RELATED SU...

Created: 2012-08-13 16:46:39

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    Bulk drug during its production process, after its scale up, it is necessary to analyse for the presence of any impurities or related substances in it. This is to ensure the impurities and related substances are within their limits as per ICH Guidelines. The impurities and related substances are defined as; Impurity: Any component present in the drug substance or drug product which is not the desired product, a product-related substance, or excipient including buffer com...

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Blob Process for the preparation of amorphous atorvastati...

Created: 2012-07-24 12:07:03

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Atorvastatin calcium is a drug compound that is used as a lipid-lowering agent, fortreating hypercholesterolemia. The compound has the chemical name[R-(R*,R*)]-2-(4-fluorophenyl)-3,ö-dihydroxy-5-(1-methylethyl)-3-phenyl-4-{(phenylamino)carbonyl}-1H-pyrolle-1-hepatonic acid, calcium salt (2:1) trihydrate. Pharmaceutical productscontaining crystalline atorvastatin calcium trihydrate are sold using the trademarkLIPITOR.

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Blob Novel polymorph of 5-cyanopthalide high purity inter...

Created: 2012-07-24 12:02:16

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The present invention relates to obtaining a new polymorph of 5-Cyanophthalide in highly pure form (99.5 to 99.99%), which is an intermediate used forthe synthesis of citalopram& escitalopram both of which are potent antidepressant drugs.Moreover this new polymorph of 5-cyanophthalide does not contain impurities liketerephthalic acid & diphthalide derivatives.        

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Blob Enantioselective method of synthesizing methylphenid...

Created: 2012-07-24 11:51:52

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Process for the preparation of enantioselective method of making methylphenidate and derivatives . The method involves use of a rhodium catalyst, and selectively produces the D-enantiomer of the methylphenidate derivative in excess of the L-enantiomer . Furthermore, the method selectively produces the threo-diastereomer in excess of the erythro-diastereomer. The method is thus suitable for synthesis of D-threo-methylphenidate (the biologically active form of this compound) and derivatives &...

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Blob Quality Assurance and GMP and ICH

Created: 2012-07-24 11:46:03

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Quality Assurance is a planned and systematic approach to generate enough confidence in the quality of the product and processes in the long run as per the specifications." In this biog you will find post related to ICH, GMP and Quality related matters.

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Blob Industrial process for OXICONAZOLE Dr Krishnasarma P...

Created: 2012-07-24 11:38:44 | Last updated: 2013-06-21 09:49:15

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Industrial process for OXICONAZOLE Dr Krishnasarma PathyOxiconazole inhibits ergosterol biosynthesis, which is required forcytoplasmic membrane integrity of fungi. It acts to destabilize the fungal cyctochromeP450 51 enzyme (also known as Lanosterol 14-alpha demethylase). This is vital in thecell membrance structure of the fungus. Its inhibition leads to cell lysis. Oxiconazole hasalso been shown in inhibit DNA synthesis and suppress intracellular concentrations ofATP. Like other imidazole an...

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Blob GLIBENCLAMIDE Complexes ( Complexes of Mg,Cr,Ni,Zn a...

Created: 2012-07-24 11:33:50 | Last updated: 2012-07-24 11:33:51

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The N-acetyl derivative of β-phenethylamine is reacted with chlorosulfonic acid to form the para sulfonyl chloride derivative. This is then subjected to ammonolysis, followed by base-catalyzed removal of the acetamide. This is then acylated with 2-methoxy-5-chlorobenzoic acid chloride to give the amide intermediate. This is then reacted with cyclohexyl isocyanate to yield the sulfonylurea glibenclamide

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Blob HOW TO START ANALYTICAL METHOD DEVELOPMENT

Created: 2012-07-24 11:28:31

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 A bulk drug during its production process, after its scale up, it is necessary to analyse for the presence of any impurities or related substances in it. This is to ensure the impurities and related substances are within their limits as per ICH Guidelines.The impurities and related substances are defined as; Impurity: Any component present in the drug substance or drug product which is not the desired product, a product-related substance, or excipient including buffer components. I...

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Blob DEFINITION “IMPURITY”

Created: 2012-07-24 11:18:54

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Impurities are normally generated during the formation of Active PharmaceuticalIngredients and their intermediates. Chances of their generation during Drug Productsformation are less as formulation is a physical blending process. Care is taken that theseexcipients do not react with each other to produce the degradants. They may consist oforganic and inorganic, and define levels at which impurities/degradants should beidentified.ICH Q3A covers drug substances and Q3B covers drug products. Th...

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Blob Improved process for preparing L-phenylephrine hydro...

Created: 2012-07-24 11:12:15

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The present invention relates to an improved process for preparing L-phenylephrinehydrochloride on an industrial scale    

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Blob PROCESS FOR PREPARATIN OF VITAMIN-C-Dr.krishnasarma ...

Created: 2012-07-24 11:03:13

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Ascorbic acid (vitamin C) is a water-soluble vitamin. It occurs as a white or slightly yellowcrystal or powder with a slight acidic taste. It is an antiscorbutic product. On exposure to light, itgradually darkens. In the dry state, it is reasonably stable in air, but in solution it rapidlyoxidizes. Ascorbic acid (vitamin c) is freely soluble in water; sparingly soluble in alcohol;insoluble in chloroform, in ether, and in benzene. The chemical name of ascorbic acid (vitaminc) is L-ascorbic a...

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Blob Industrial process for preparation of Levetiracetam....

Created: 2012-07-24 10:59:51

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         Levetiracetam belongs to the class of compounds used in the treatment of epilepsy so it.has huge demand in market and it is worth to develop the product.

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Blob solid-state forms of celecoxib andAN IMPROVED PROCE...

Created: 2012-07-24 10:54:47

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          The present application provides an improved process for the preparation  of          4-[5-(4-methylphenyl)-3- (trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide           (Celecoxib) and its purification and crystallisation to produce polymorph .  

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Blob Amorphous solids - Pharmaceutical technology and d...

Created: 2012-07-24 10:45:30

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Blob A Primer on Intellectual Property Rights-Dr.krishnas...

Created: 2012-07-24 10:39:44

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  nTypes of Intellectual Property   nWhat is a Patent , its requirements & specification   nPatent claims   nCriteria for claiming inventors   nTypes of patents   nInfringement & validity of patent   nIndian patent scenario   nPatent Cooperation Treaty (PCT)   nDifferences in patent Laws   nPatent Resources  

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