際際滷shows by User: shivang47 / http://www.slideshare.net/images/logo.gif 際際滷shows by User: shivang47 / Tue, 19 Jun 2018 13:04:15 GMT 際際滷Share feed for 際際滷shows by User: shivang47 QbD for "Drug Eluting Stents (DES)" by Dr. K.McDemott & S.Chatterjee /slideshow/qbd-for-drug-eluting-stents-des-by-dr-kmcdemott-schatterjee/102654216 qbddrugelutingstents-180619130415
The drug coating process for coated drug-eluting stents (DES) has been identified as a key source of inter- and intra-batch variability in drug elution rates. Quality-by-design (QbD) principles were applied to gain an understanding of the ultrasonic spray coating process of DES. Statistically based design of experiments (DOE) were used to understand the relationship between ultrasonic atomization spray coating parameters and dependent variables such as coating mass ratio, roughness, drug solid state composite microstructure, and elution kinetics. Defect-free DES coatings composed of 70% 85:15 poly(DL-lactide-co-glycolide) and 30% everolimus were fabricated with a constant coating mass. The drug elution profile was characterized by a mathematical model describing biphasic release kinetics. Model coefficients were analyzed as a DOE response. Changes in ultrasonic coating processing conditions resulted in substantial changes in roughness and elution kinetics. Based on the outcome from the DOE study, a design space was defined in terms of the critical coating process parameters resulting in optimum coating roughness and drug elution. This QbD methodology can be useful to enhance the quality of coated DES.]]>
The drug coating process for coated drug-eluting stents (DES) has been identified as a key source of inter- and intra-batch variability in drug elution rates. Quality-by-design (QbD) principles were applied to gain an understanding of the ultrasonic spray coating process of DES. Statistically based design of experiments (DOE) were used to understand the relationship between ultrasonic atomization spray coating parameters and dependent variables such as coating mass ratio, roughness, drug solid state composite microstructure, and elution kinetics. Defect-free DES coatings composed of 70% 85:15 poly(DL-lactide-co-glycolide) and 30% everolimus were fabricated with a constant coating mass. The drug elution profile was characterized by a mathematical model describing biphasic release kinetics. Model coefficients were analyzed as a DOE response. Changes in ultrasonic coating processing conditions resulted in substantial changes in roughness and elution kinetics. Based on the outcome from the DOE study, a design space was defined in terms of the critical coating process parameters resulting in optimum coating roughness and drug elution. This QbD methodology can be useful to enhance the quality of coated DES.]]> Tue, 19 Jun 2018 13:04:15 GMT /slideshow/qbd-for-drug-eluting-stents-des-by-dr-kmcdemott-schatterjee/102654216 shivang47@slideshare.net(shivang47) QbD for "Drug Eluting Stents (DES)" by Dr. K.McDemott & S.Chatterjee shivang47 The drug coating process for coated drug-eluting stents (DES) has been identified as a key source of inter- and intra-batch variability in drug elution rates. Quality-by-design (QbD) principles were applied to gain an understanding of the ultrasonic spray coating process of DES. Statistically based design of experiments (DOE) were used to understand the relationship between ultrasonic atomization spray coating parameters and dependent variables such as coating mass ratio, roughness, drug solid state composite microstructure, and elution kinetics. Defect-free DES coatings composed of 70% 85:15 poly(DL-lactide-co-glycolide) and 30% everolimus were fabricated with a constant coating mass. The drug elution profile was characterized by a mathematical model describing biphasic release kinetics. Model coefficients were analyzed as a DOE response. Changes in ultrasonic coating processing conditions resulted in substantial changes in roughness and elution kinetics. Based on the outcome from the DOE study, a design space was defined in terms of the critical coating process parameters resulting in optimum coating roughness and drug elution. This QbD methodology can be useful to enhance the quality of coated DES. <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/qbddrugelutingstents-180619130415-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> The drug coating process for coated drug-eluting stents (DES) has been identified as a key source of inter- and intra-batch variability in drug elution rates. Quality-by-design (QbD) principles were applied to gain an understanding of the ultrasonic spray coating process of DES. Statistically based design of experiments (DOE) were used to understand the relationship between ultrasonic atomization spray coating parameters and dependent variables such as coating mass ratio, roughness, drug solid state composite microstructure, and elution kinetics. Defect-free DES coatings composed of 70% 85:15 poly(DL-lactide-co-glycolide) and 30% everolimus were fabricated with a constant coating mass. The drug elution profile was characterized by a mathematical model describing biphasic release kinetics. Model coefficients were analyzed as a DOE response. Changes in ultrasonic coating processing conditions resulted in substantial changes in roughness and elution kinetics. Based on the outcome from the DOE study, a design space was defined in terms of the critical coating process parameters resulting in optimum coating roughness and drug elution. This QbD methodology can be useful to enhance the quality of coated DES.
QbD for "Drug Eluting Stents (DES)" by Dr. K.McDemott & S.Chatterjee from Shivang Chaudhary
]]> 539 4 https://cdn.slidesharecdn.com/ss_thumbnails/qbddrugelutingstents-180619130415-thumbnail.jpg?width=120&height=120&fit=bounds presentation Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 QbD Model Case Study of MONOCLONAL ANTIBODY : A-Mab. /slideshow/qbd-model-case-study-of-monoclonal-antibody-amab/68064897 a-mabcasestudyversion2-1-161102150948
The A-Mab Case Study involved the efforts of many individuals from CMC-BWG and would not have been made possible if it were not for the countless number of hours spent by the 5 participating companies (GlaxosmithKline, MedImmune, Merck, Pfizer, PWC and sanofi pasteur).]]>
The A-Mab Case Study involved the efforts of many individuals from CMC-BWG and would not have been made possible if it were not for the countless number of hours spent by the 5 participating companies (GlaxosmithKline, MedImmune, Merck, Pfizer, PWC and sanofi pasteur).]]> Wed, 02 Nov 2016 15:09:48 GMT /slideshow/qbd-model-case-study-of-monoclonal-antibody-amab/68064897 shivang47@slideshare.net(shivang47) QbD Model Case Study of MONOCLONAL ANTIBODY : A-Mab. shivang47 The A-Mab Case Study involved the efforts of many individuals from CMC-BWG and would not have been made possible if it were not for the countless number of hours spent by the 5 participating companies (GlaxosmithKline, MedImmune, Merck, Pfizer, PWC and sanofi pasteur). <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/a-mabcasestudyversion2-1-161102150948-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> The A-Mab Case Study involved the efforts of many individuals from CMC-BWG and would not have been made possible if it were not for the countless number of hours spent by the 5 participating companies (GlaxosmithKline, MedImmune, Merck, Pfizer, PWC and sanofi pasteur).
QbD Model Case Study of MONOCLONAL ANTIBODY : A-Mab. from Shivang Chaudhary
]]> 5908 9 https://cdn.slidesharecdn.com/ss_thumbnails/a-mabcasestudyversion2-1-161102150948-thumbnail.jpg?width=120&height=120&fit=bounds document Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 QbD Model Case Study of VACCINE : A-Vax. /slideshow/qbd-model-case-study-of-vaccine-avax/68063777 a-vax-applying-qbd-to-vaccines-161102144632
The A-VAX Case Study involved the efforts of many individuals and would not have been made possible if it were not for the countless number of hours spent by the 5 participating companies (GlaxosmithKline, MedImmune, Merck, Pfizer, and sanofi pasteur).]]>
The A-VAX Case Study involved the efforts of many individuals and would not have been made possible if it were not for the countless number of hours spent by the 5 participating companies (GlaxosmithKline, MedImmune, Merck, Pfizer, and sanofi pasteur).]]> Wed, 02 Nov 2016 14:46:32 GMT /slideshow/qbd-model-case-study-of-vaccine-avax/68063777 shivang47@slideshare.net(shivang47) QbD Model Case Study of VACCINE : A-Vax. shivang47 The A-VAX Case Study involved the efforts of many individuals and would not have been made possible if it were not for the countless number of hours spent by the 5 participating companies (GlaxosmithKline, MedImmune, Merck, Pfizer, and sanofi pasteur). <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/a-vax-applying-qbd-to-vaccines-161102144632-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> The A-VAX Case Study involved the efforts of many individuals and would not have been made possible if it were not for the countless number of hours spent by the 5 participating companies (GlaxosmithKline, MedImmune, Merck, Pfizer, and sanofi pasteur).
QbD Model Case Study of VACCINE : A-Vax. from Shivang Chaudhary
]]> 2309 6 https://cdn.slidesharecdn.com/ss_thumbnails/a-vax-applying-qbd-to-vaccines-161102144632-thumbnail.jpg?width=120&height=120&fit=bounds document Black http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 "How to draft a PATENT Specification?" /shivang47/how-to-draft-a-patent-specification howtodraftapatentbyshivangchaudharyciieiima-151023091611-lva1-app6891
A Ready Reference Guide for Learning "How to draft effective PATENT specification?" 1. Title 2. Technical Field 3. Background 4. Object 5. Statement 6. Summary 7. Drawings 8. DESCRIPTION (What the invention is>, How it is Made/ Used/ Works/ Looks) 9. CLAIMS 10.ABSTRACT ]]>
A Ready Reference Guide for Learning "How to draft effective PATENT specification?" 1. Title 2. Technical Field 3. Background 4. Object 5. Statement 6. Summary 7. Drawings 8. DESCRIPTION (What the invention is>, How it is Made/ Used/ Works/ Looks) 9. CLAIMS 10.ABSTRACT ]]> Fri, 23 Oct 2015 09:16:11 GMT /shivang47/how-to-draft-a-patent-specification shivang47@slideshare.net(shivang47) "How to draft a PATENT Specification?" shivang47 A Ready Reference Guide for Learning "How to draft effective PATENT specification?" 1. Title 2. Technical Field 3. Background 4. Object 5. Statement 6. Summary 7. Drawings 8. DESCRIPTION (What the invention is>, How it is Made/ Used/ Works/ Looks) 9. CLAIMS 10.ABSTRACT <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/howtodraftapatentbyshivangchaudharyciieiima-151023091611-lva1-app6891-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br> A Ready Reference Guide for Learning &quot;How to draft effective PATENT specification?&quot; 1. Title 2. Technical Field 3. Background 4. Object 5. Statement 6. Summary 7. Drawings 8. DESCRIPTION (What the invention is&gt;, How it is Made/ Used/ Works/ Looks) 9. CLAIMS 10.ABSTRACT
"How to draft a PATENT Specification?" from Shivang Chaudhary
]]> 1831 8 https://cdn.slidesharecdn.com/ss_thumbnails/howtodraftapatentbyshivangchaudharyciieiima-151023091611-lva1-app6891-thumbnail.jpg?width=120&height=120&fit=bounds presentation 000000 http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 FMEA, DoE & PAT : Three Inseparable Organs of Quality Risk Management (QRM) Body for Pharmaceutical Product Development with QbD /slideshow/fmea-doe-pat-three-inseparable-organs-of-quality-risk-management-qrm-body-for-pharmaceutical-product-development-with-qbd/31869487 fmea-20doe-20pat-203-20in-201-20by-20shivang-20chaudhary-140303201743-phpapp01
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]]> Mon, 03 Mar 2014 20:17:43 GMT /slideshow/fmea-doe-pat-three-inseparable-organs-of-quality-risk-management-qrm-body-for-pharmaceutical-product-development-with-qbd/31869487 shivang47@slideshare.net(shivang47) FMEA, DoE & PAT : Three Inseparable Organs of Quality Risk Management (QRM) Body for Pharmaceutical Product Development with QbD shivang47 <img style="border:1px solid #C3E6D8;float:right;" alt="" src="https://cdn.slidesharecdn.com/ss_thumbnails/fmea-20doe-20pat-203-20in-201-20by-20shivang-20chaudhary-140303201743-phpapp01-thumbnail.jpg?width=120&amp;height=120&amp;fit=bounds" /><br>
FMEA, DoE & PAT : Three Inseparable Organs of Quality Risk Management (QRM) Body for Pharmaceutical Product Development with QbD from Shivang Chaudhary
]]> 6275 4 https://cdn.slidesharecdn.com/ss_thumbnails/fmea-20doe-20pat-203-20in-201-20by-20shivang-20chaudhary-140303201743-phpapp01-thumbnail.jpg?width=120&height=120&fit=bounds presentation 000000 http://activitystrea.ms/schema/1.0/post http://activitystrea.ms/schema/1.0/posted 0 https://cdn.slidesharecdn.com/profile-photo-shivang47-48x48.jpg?cb=1713712458 Shiv is a post graduate [MS Pharm (Pharmaceutics)] from NIPER & functioning as a leading QbD evangelist for Drug Product Formulation Development & Process Optimization as well as Scale-Up, Technology Transfer, Validation & Commercialization. As a senior "Formulation Engineer", Shiv is mainly associated with Pharma R&Ds& Regulatory agencies as a Lean 6 Quality by DESIGN (QbD) & Process Analytical TECHNOLOGY (PAT) Project Professional; his core expertise are: Drug Product Formulation & Process Development as well as Scale-Up, Technology Transfer, Validation & Commercialization of SOLID ORAL (Tablet IR / MR MUPS Hard Gelatin & SoftGel Capsule), LIQUID ORAL (Solution Suspens... https://www.facebook.com/pages/Quality-by-Design-Process-Analytical-Technology-QbDPAT/305769212945418?ref=aymt_homepage_panel https://cdn.slidesharecdn.com/ss_thumbnails/qbddrugelutingstents-180619130415-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/qbd-for-drug-eluting-stents-des-by-dr-kmcdemott-schatterjee/102654216 QbD for &quot;Drug Eluting ... https://cdn.slidesharecdn.com/ss_thumbnails/a-mabcasestudyversion2-1-161102150948-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/qbd-model-case-study-of-monoclonal-antibody-amab/68064897 QbD Model Case Study o... https://cdn.slidesharecdn.com/ss_thumbnails/a-vax-applying-qbd-to-vaccines-161102144632-thumbnail.jpg?width=320&height=320&fit=bounds slideshow/qbd-model-case-study-of-vaccine-avax/68063777 QbD Model Case Study o...