Advanceutics Inc.
Advancing Pharmaceutical Development, Manufacturing, QbD, Regulatory CMC
Advancing Pharmaceutical Development, Manufacturing, QbD, Regulatory CMC
Programmed and Led Recent Workshops
- Programmed and led workshops organized by CACO-PBS at Foster City, CA. Gave 2 lectures
- "CMC Strategies for Robust Product Development & NDA Submission", June 13th, 2012.
- "Solid Oral Dosage Forms: Theory, Formulation Design, and Case Studies", June 10th 2010.
- Led, organized, moderated, and presented at panel discussions:
- "Biopharmaceutics: Dying area or A Resurgent Area" at AAPS BADG, San Mateo, in 9/2009.
- "Poorly Soluble Drugs: Strategies and Approaches", as a joint event between AAPS BADG & CACO-PBS, Foster City, in 1/2010.
Publications / Patents
- Co-author for book chapter titled "Process Development and Scale-Up of Oral Fast-Dissolving Tablets" in a book titled "Drug Delivery to the Oral Cavity" (Publishers: CRC Press).View this book @ Amazon Books
- Co-Inventor for "Oral Fast Melt Formulation of a Cyclooxygenase-2 Inhibitor", US patent publication #2002/0119193.View this Patent Application
- Co-author for Review Article titled "Recent Technological Advances in Oral Drug Delivery - A Review", Pharmaceutical Science & Technology Today, April 2000, Volume 3, Number 4, pg 138-45.View this Article
- Co-Inventor for "Tablets Quickly Disintegrating in the Oral Cavity and Process for Producing the Same", Issued European Patent # 1072256, Issued US Patent # 6,589,554.View this Patent
- Co-Inventor for "Water Soluble Polymer Based Rapidly Dissolving Tablets and Production Process Thereof", Issued US Patent #6,465,009.View this Patent
- Co inventor of patent application "Sustained Release Pharmaceutical (Ranolazine) Formulations", US application 2006/0177502, currently in review at US PTO.
- Co inventor of patent application "A1 Adenosine Receptor Agonist Polymorphs", US application 2011/0039799, currently in review at US PTO.
Lecture Presentations
- Presented a lecture on "Predicting plasma profiles based on physico chemical attributes and in vitro dissolution profiles for LCM products" at Department of Pharmaceutics, University of Pacific, and Stockton, CA in July 2013.
- Presented a lecture titled "Pharmaceutical Developability Risk Assessment - Premise, Approach, Examples" at Department of Pharmaceutics, University of Pacific, Stockton, CA in May 2013.
- Presented a lecture titled "Strategizing Pharmaceutical Development Activities for Drug Product", at a workshop on "CMC Strategies for Robust Product Development & NDA Submission", organized by CACO-PBS at Foster City, CA, June 13th 2011.View this Presentation Slides
- Presented a lecture titled "Scale-up, Process Validation, and Post Approval Changes for Drug Product" at a workshop on "CMC Strategies for Robust Product Development & NDA Submission", organized by CACO-PBS at Foster City, CA, June 13th 2011.View this Presentation Slides
- Presented a lecture titled "Challenges and Opportunities for Current Generation of Poorly Soluble drugs" at BITS-Pilani Hyderabad campus (India) in September 2010.
- Presented a lecture titled "Scientific and Engineering Basis for Scale-up of Solid Oral Dosage Forms" at Alliance Institute for Health & Pharmaceutical Sciences, Hyderabad (India) in August 2010.
- Presented a lecture titled "Role of Pharmaceutical Scientist in Adding Value to Overall Drug Development" at Alliance Institute for Health & Pharmaceutical Sciences, Hyderabad in August 2010.
- Presented a lecture titled "Optimizing Discovery - Development Interface for Development of NCEs" at ANU, Guntur, Andhra Pradesh (India) in August 2010.
- Presented a lecture titled "Pharmaceutical Developability Risk Assessment and Strategies", at a workshop on "Solid Oral Dosage Forms: Theory, Formulation Design, and Case Studies", jointly organized by CACO-PBS & University of Pacific, Stockton, Foster City, CA, June 10th 2010.
- Presented a lecture titled "Case Studies - Engineering Quality in Product Development, Scale-up, and Process Validation" at a workshop on "Solid Oral Dosage Forms: Theory, Formulation Design, and Case Studies", jointly organized by CACO-PBS & University of Pacific, Stockton, Foster City, CA, June 10th 2010.View this Presentation Slides
- Presented a lecture titled "Pharmaceutical (formulation and process) Development: A Value Add Component in Drug Development" at Chinese American Biopharmaceutical Society (CABS), Foster City, CA on June 5th, 2010.View this Presentation Slides
- Programmed and moderated a panel discussion titled "Poorly soluble drugs: pharmaceutical development strategies and approaches for pre clinical applications" held as a joint dinner event between AAPS BAG and CACO in Foster City on January 20th 2010.
- Presented a lecture on "Predicting plasma profiles based on physico chemical attributes and in vitro dissolution profiles for LCM products" at Department of Pharmaceutics, University of Pacific, and Stockton, CA in November 2006.
- Led and moderated a technical panel discussion on "Biopharmaceutics: A dying Area or resurgent Area" as part of BADG (affiliated with AAPS) dinner event in September 2009.
- Presented a lecture titled "Pharmaceutical Developability Risk Assessment - Premise, Approach, Examples" at Department of Pharmaceutics, University of Pacific, Stockton, CA in November 2006.
- Presented a lecture titled "Biopharmaceutical Properties Effecting Oral Absorption" at CV Therapeutics, Palo Alto in June 2008.
- Led and moderated a technical panel discussion on "Developability Assessment in Lead Optimization & Candidate Nomination" as part of BADG (affiliated with AAPS) quarterly discussion on Pharmaceutical Sciences" in San Mateo, CA in March 2008.
- Presented a lecture titled "Application of statistical tools in pharmaceutical process development", as part of graduate course on "Bio Statistics" at the Department of Pharmaceutics, University of Pacific, Stockton, CA in November 2006.
- Presented a lecture titled "Engineering Quality in Pharmaceutical PD Lifecycle", as part of graduate course on "Pharmaceutical Technologies" at the Department of Pharmaceutics, University of Pacific, Stockton, CA in June 2004.
- Presented a lecture titled "Scale-up & Technology Transfer of Pharmaceutical Products: Science, Engineering & Intangibles", as part of graduate course on "Pharmaceutical Technologies" at the Department of Pharmaceutics, University of Pacific, Stockton, CA in May 2004.
- Presented a lecture titled "Application of SUPAC in Pharmaceutical Product Development", as part of graduate course on "Pharmaceutical Technologies" at the Department of Pharmaceutics, University of Pacific, Stockton, CA in July 2003.
- Presented a lecture titled "Process Validation: History, Principles, Approaches & Quality Engineering Tools", as part of graduate course on "Pharmaceutical technologies" at the Department of Pharmaceutics, University of Pacific, Stockton, CA in May 2003.
- Presented a lecture titled "Blending & Blend Uniformity Analysis for Solid Oral Dosage Forms" at CV Therapeutics, Palo Alto, CA in April 2003.
- Presented a lecture titled "Statistical Optimization Techniques in Pharmaceutical product Development" at CV Therapeutics, Palo Alto, CA in September 2003.
- Presented a lecture titled "Process Development and Scale-up of Oral Fast Disintegrating Tablet - Wowtab Technology", as part of short course on "Advanced Practices in Pharmaceutical Tablet and Capsule Technology" held in May 2001, at Las Vegas, NV.
- Presented a two hour interactive seminar on "Product Quality and Design Approaches in Pharmaceutical Process Development" at YPT, Palo Alto as a training course for staff from various departments in March 2001.
- Presented a two hour interactive seminar on "Writing development reports and protocols - development, CTM, Scale-up, Process Validation and Technology Transfer - in PD cycle" at YPT, Palo Alto, as a training course in April 2000 and February 2001.
- Organizer and Co-Moderator for the Round Table Discussion titled "Statistical Process Capability in Manufacturing Process Validation" at the Annual AAPS meeting held Nov. 99 at New Orleans, LO. As part of discussion, presented a lecture titled "Introduction to Statistical Process Capability".View this Presentation Slides
- Presented a two hour interactive seminar on "Statistical Methods in Manufacturing Process Validation" in Shaklee Co., as a training course in October, 1995 at Hayward, CA
Poster Presentations
- Presented a poster titled "Effect of Alcohol on the Release Pattern of Marketed Controlled Release Formulations" at the Annual AAPS Meeting and Exposition held in Nov. 2010 at New Orleans, LO.
- Presented a poster titled "Effect of Alcohol on in vitro release of Metoprolol from its Sustained Release Matrix Formulations" at the Annual AAPS Meeting and Exposition held in Nov. 2010 at New Orleans, LO.
- Presented a poster titled "Influence of Alcohol on Theophylline release from its Sustained Release Formulations" at the Annual AAPS Meeting and Exposition held in Nov. 2010 at New Orleans, LO.
- Presented a poster titled "Application of second generation (Cpm & Cpmk) Process Capability Indices (PCIs) in addition to standard PCIs (Cp, Cpl, Cpu, K, Cpk) in quantifying manufacturing process performance of a pharmaceutical solid oral dosage form" at the Annual AAPS Meeting and Exposition held in Nov. 2003 at Salt Lake City, UT.
- Presented a poster titled "Influence of alcohol on theophylline release from its sustained release formulations" at the Annual AAPS Meeting and Exposition held in Nov. 2010 at New Orleans, LO.
- Presented a poster titled "Box-Benken Design in Optimization of Spray Drying Process to Obtain Taste Masked Material for an Active Pharmaceutical Ingredient (YEU551)" at the Annual AAPS Meeting and Exposition held in Nov. 99 at New Orleans, LO.
- Presented a poster titled "Particle Coating of an Active Pharmaceutical Ingredient (YEU551) using Wurster Column for Taste Masking Purposes in Fast Disintegrating Tablets" at the Annual AAPS Meeting and Exposition held in Nov.99 at New Orleans, LO.
- Presented a poster titled "Statistical Process Capability Analysis in Demonstrating Manufacturing Process Validation - A Case Study" at the Annual AAPS Meeting and Exposition held in Nov. 1997 at Boston, MA.
- Presented a poster titled "Scale-up and Establishing Manufacturing Feasibility of Wowtab Ô Technology for Quick Dissolving Tablets at Commercial Batch Sizes" at the Annual AAPS Meeting and Exposition held in Nov. 1997 at Boston, MA.
- Presented a Poster titled "Statistical Process Capability Indices in Evaluating Powder Flow on A Tablet Press", at the Annual AAPS Meeting and Exposition, held in Oct. 1996 at Seattle, WA.
- Presented a Poster on "Rotatable Composite Design in the Development of Extended Release Tablet Formulation using Hydrophilic and Lipophilic Lipids", at the Annual AAPS Meeting and Exposition, held in Nov. 15-19, 1992 at San Antonio, TX.