Zobrazeno 1 - 9 of 9 pro vyhledávání: '"HANIMI REDDY BAPATU"'
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Akademický článek
Analytical Quality by Design Approach to Test Method Development and Validation in Drug Substance Manufacturing
Autor: N. V. V. S. S. Raman, Useni Reddy Mallu, Hanimi Reddy Bapatu
Publikováno v: Journal of Chemistry, Vol 2015 (2015)
Pharmaceutical industry has been emerging rapidly for the last decade by focusing on product Quality, Safety, and Efficacy. Pharmaceutical firms increased the number of product development by using scientific tools such as QbD (Quality by Design) and
Externí odkaz: https://doaj.org/article/fde64835856143e68e79463dbd0372ce
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2
A QBD WITH THE FRACTIONAL FACTORIAL DESIGN WAS USED TO MATCH THE SIMILARITY BETWEEN RANOLAZINE EXTENDED-RELEASE TABLETS 500 MG AND 1000 MG
Autor: SANKARAIAH JONNA, HANIMI REDDY BAPATU, PRAVEEN SUBBAPPA, KALIYAPERUMAL SARAVANAN
Publikováno v: International Journal of Applied Pharmaceutics. :98-105
Objective: Formulation and development of Ranolazine extended-release Tablets 500 mg and 1000 mg by using QBD with Fractional factorial design to match the similarity with Branded formulation (RANEXA®). Methods: Ranolazine extended-release tablets w
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::51b9cf674bc7398e5dbed8a8f2a0f4d0
https://doi.org/10.22159/ijap.2023v15i2.47241
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3
Stability Indicating HPLC Method for Quantification of Solifenacin Succinate & Tamsulosin Hydrochloride along with Its Impurities in Tablet Dosage Form
Autor: So Jin Park, Woo Hyong Cho, Hari Kishan Reddy Ganthi, Raveendra Reddy P, Hanimi Reddy Bapatu, Young Jun Park
Publikováno v: American Journal of Analytical Chemistry. :840-862
A novel stability-indicating RP-HPLC method was developed and validated for simultaneous determination of Solifenacin Succinate & Tamsulosin Hydrochloride and its impurities in tablet dosage form. The method was developed using L1 column with gradien
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::c0e1e2e34e98e6567757e3215b6a11d1
https://doi.org/10.4236/ajac.2016.711073
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4
QbD Approach Method Development for Estimation of Dabigatran Etexilate along with Its Impurities and Identification of Degradants in Capsule Dosage Form
Autor: Venkat Bhaskar Rao Pasagadugula, Woo Hyung Cho, Hanimi Reddy Bapatu, Ravi Kumar Maram
Publikováno v: American Journal of Analytical Chemistry. :494-524
The concept of Quality by Design was demonstrated in the development of a stability-indicating assay and related substances method by HPLC for Dabigatran Etexilate Capsules dosage form. Method design, method evaluation, method control and life cycle
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::0b627ed0d1b0a42ee5d3346cff7ed160
https://doi.org/10.4236/ajac.2016.76047
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5
Robust and Rugged Stability-Indicating HPLC Method for the Determination of Plerixafor and Its Related Impurities in Drug Substances
Autor: Hanimi Reddy Bapatu, Ravi Kumar Maram, R Satyanarayana Murthy
Publikováno v: Journal of Chromatographic Science. 53:1432-1442
A novel, reversed-phase high-performance liquid chromatographic method was developed and validated for the determination of related substances in Plerixafor (PLX) drug substance. PLX is an immunostimulant used to mobilize hematopoietic stem cells in
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c549fd6de2af54a94deb6bb6488b57a0
https://doi.org/10.1093/chromsci/bmv029
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7
Stability-Indicating HPLC Method for Quantification of Celecoxib and Diacerein Along With Its Impurities in Capsule Dosage Form
Autor: R Satyanarayana Murthy, Ravi Kumar Maram, Hanimi Reddy Bapatu
Publikováno v: Journal of Chromatographic Science. 53:144-153
A novel stability-indicating reverse phase high performance liquid chromatography method was developed and validated for the simultaneous determination of Celecoxib (CEL) and Diacerein (DIN) and its impurities in capsule dosage form. The method was d
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c45c66a0c8da34320344fd3356c6f99f
https://doi.org/10.1093/chromsci/bmu031
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8
Analytical Quality by Design Approach to Test Method Development and Validation in Drug Substance Manufacturing
Autor: Hanimi Reddy Bapatu, Useni Reddy Mallu, N. V. V. S. S. Raman
Publikováno v: Journal of Chemistry, Vol 2015 (2015)
Pharmaceutical industry has been emerging rapidly for the last decade by focusing on product Quality, Safety, and Efficacy. Pharmaceutical firms increased the number of product development by using scientific tools such as QbD (Quality by Design) and
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ddec4117e24f42a3974e30ab7a952f04
https://doaj.org/article/fde64835856143e68e79463dbd0372ce
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9
API Supplier Change or Addition of Alterate API Supplier in Generic Drug Products: Cost, Quality and Regulatory Factors
Autor: Jonna Sankar, Santosh Narla, Narendra Kumar Thamma, Pavan Kumar M, Nvvss Raman, Tejas, Arunkanth Krishnakumar Nair, Useni Reddy Mallu, Hanimi Reddy Bapatu
Publikováno v: Pharmaceutica Analytica Acta.
Generic drug product (GDP) competition for market existence and profitability has become a challenging task for the manufacturers. All the generic players are putting intensive efforts to enter the market with competitive price and consistent drug pr
Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::0a7a5ead407ddd24f9f565d767f08edf
https://doi.org/10.4172/2153-2435.1000364
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