Phillip Lunney - Academia.edu (original) (raw)

Papers by Phillip Lunney

Research paper thumbnail of An Elective Course on Dermatological Topics and Cosmeceutical Compounding

American Journal of Pharmaceutical Education, 2014

To implement and assess a pharmacy dermatology and cosmeceutical compounding elective course and ... more To implement and assess a pharmacy dermatology and cosmeceutical compounding elective course and its impact on graduates' careers. A 3-credit elective course that incorporated classroom lectures on ambulatory dermatologic diseases and cosmeceutical products with case studies, weekly quizzes, and a comprehensive business plan project was implemented in a doctor of pharmacy (PharmD) program in 2010. Assessment instruments including weekly quizzes, a business plan project, and pre- and post-course tests were used to evaluate course content. Across 3 offerings of the course (2010, 2011, 2012), pre- and post-course test scores improved. Results of a postgraduate survey showed that 54% of respondents worked at a pharmacy offering compounding services, and 57% felt that the course played a significant or very significant role in their counseling on dermatologic conditions. Assessment methods revealed student learning of course content and the course appeared moderately beneficial to graduates' early careers. A more longitudinal analysis is needed to assess the course's impact on long-term career choices, particularly those dealing with compounding of cosmeceutical products.

Research paper thumbnail of Investigation of the Statistical Power of the Content Uniformity Tests Using Simulation Studies

Journal of Pharmaceutical Innovation, Mar 1, 2009

A simulation study was performed to investigate the statistical power of the revised US Pharmacop... more A simulation study was performed to investigate the statistical power of the revised US Pharmacopeial Convention, Inc. <905> and Bergum's revised test acceptance limits for 95% confidence. In this simulation exercise, relatively small artificial lots of dosage units (20,000 U) were created to represent various probability distributions with increasing levels of defects. A simulation tool was developed to extract valid samples from each lot and perform the compendial test repeatedly for a minimum of 11,000 trials. This paper describes the results of these simulation trials.

Research paper thumbnail of Effects of additives on the performance of two-component waterborne polyurethane coatings

Journal of Coatings Technology, 1999

The effects of various additives and solvents on a coating’s performance in a two-component water... more The effects of various additives and solvents on a coating’s performance in a two-component waterborne polyurethane coating system are studied using a statistical experimental design method. Using a blocked arrangement of fractional factorial design matrices, six different independent variables, including the use of different additives, catalysts, as well as solvents at different levels, were examined for their effects on various coating performance parameters, such as gloss, hardness, viscosity, and chemical resistance. Statistical analysis revealed several significant effects of these additives on the coating performances. Most importantly, several two-factor interactions between additives were also found to significantly influence the performance properties of the coating. These interactions could be very difficult to detect using traditional one-at-a-time experimental approaches. The information obtained from this study could be used for designing coating systems with superior performance properties.

Research paper thumbnail of Investigation of the Statistical Power of the Content Uniformity Tests Using Simulation Studies

Journal of Pharmaceutical Innovation, 2009

A simulation study was performed to investigate the statistical power of the revised US Pharmacop... more A simulation study was performed to investigate the statistical power of the revised US Pharmacopeial Convention, Inc. <905> and Bergum's revised test acceptance limits for 95% confidence. In this simulation exercise, relatively small artificial lots of dosage units (20,000 U) were created to represent various probability distributions with increasing levels of defects. A simulation tool was developed to extract valid samples from each lot and perform the compendial test repeatedly for a minimum of 11,000 trials. This paper describes the results of these simulation trials.

Research paper thumbnail of Innovation in Pharmaceutical Experimentation Part 1: Review of Experimental Designs Used in Industrial Pharmaceutics Research and Introduction to Bayesian D-Optimal Experimental Design

Journal of Pharmaceutical Innovation, 2008

The concept of design space, as described in the ICH Harmonized Tripartite Guideline Q8 for Pharm... more The concept of design space, as described in the ICH Harmonized Tripartite Guideline Q8 for Pharmaceutical Development (Q8 Pharmaceutical development, ICH harmonized tripartite guidelines, in International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, 2005), was introduced to justify regulatory flexibility in pharmaceutical manufacturing operations. The basis for this concept is that advanced understanding of variables affecting product quality, obtained either through historical operation or demonstrated through process modeling, justifies replacement of traditional process targets with acceptable operational ranges. Process adjustments that allow operation within the region defined by the design space do not require regulatory oversight. Whereas there are many advantages to having the flexibility to operate within such ranges, the concept is only valid when the design space has been adequately described by appropriate experimentation. Given the complexity of pharmaceutical processes and the number of variables to consider in developing operational ranges, only a well-executed pro-gram of experiments, supported by appropriate statistical analyses, could provide the necessary information to truly capture a design space. Thus, the risk of employing a design space is that the model will be applied to a region outside of the approved design space, either through a false statistical inference or by omitting some important factor effects. This article presents a review of the experimental strategies typically employed to develop pharmaceutical processes with special emphasis on the assumptions and limitations of the approaches. An alternative strategy that provides an opportunity to build on previous information efficiently without requiring extraordinary skill in statistics, Bayesian optimal design, is introduced as an alternative to the classical approaches.

Research paper thumbnail of An Elective Course on Dermatological Topics and Cosmeceutical Compounding

American Journal of Pharmaceutical Education, 2014

To implement and assess a pharmacy dermatology and cosmeceutical compounding elective course and ... more To implement and assess a pharmacy dermatology and cosmeceutical compounding elective course and its impact on graduates&amp;amp;amp;amp;#39; careers. A 3-credit elective course that incorporated classroom lectures on ambulatory dermatologic diseases and cosmeceutical products with case studies, weekly quizzes, and a comprehensive business plan project was implemented in a doctor of pharmacy (PharmD) program in 2010. Assessment instruments including weekly quizzes, a business plan project, and pre- and post-course tests were used to evaluate course content. Across 3 offerings of the course (2010, 2011, 2012), pre- and post-course test scores improved. Results of a postgraduate survey showed that 54% of respondents worked at a pharmacy offering compounding services, and 57% felt that the course played a significant or very significant role in their counseling on dermatologic conditions. Assessment methods revealed student learning of course content and the course appeared moderately beneficial to graduates&amp;amp;amp;amp;#39; early careers. A more longitudinal analysis is needed to assess the course&amp;amp;amp;amp;#39;s impact on long-term career choices, particularly those dealing with compounding of cosmeceutical products.

Research paper thumbnail of Investigation of the Statistical Power of the Content Uniformity Tests Using Simulation Studies

Journal of Pharmaceutical Innovation, Mar 1, 2009

A simulation study was performed to investigate the statistical power of the revised US Pharmacop... more A simulation study was performed to investigate the statistical power of the revised US Pharmacopeial Convention, Inc. <905> and Bergum's revised test acceptance limits for 95% confidence. In this simulation exercise, relatively small artificial lots of dosage units (20,000 U) were created to represent various probability distributions with increasing levels of defects. A simulation tool was developed to extract valid samples from each lot and perform the compendial test repeatedly for a minimum of 11,000 trials. This paper describes the results of these simulation trials.

Research paper thumbnail of Effects of additives on the performance of two-component waterborne polyurethane coatings

Journal of Coatings Technology, 1999

The effects of various additives and solvents on a coating’s performance in a two-component water... more The effects of various additives and solvents on a coating’s performance in a two-component waterborne polyurethane coating system are studied using a statistical experimental design method. Using a blocked arrangement of fractional factorial design matrices, six different independent variables, including the use of different additives, catalysts, as well as solvents at different levels, were examined for their effects on various coating performance parameters, such as gloss, hardness, viscosity, and chemical resistance. Statistical analysis revealed several significant effects of these additives on the coating performances. Most importantly, several two-factor interactions between additives were also found to significantly influence the performance properties of the coating. These interactions could be very difficult to detect using traditional one-at-a-time experimental approaches. The information obtained from this study could be used for designing coating systems with superior performance properties.

Research paper thumbnail of Investigation of the Statistical Power of the Content Uniformity Tests Using Simulation Studies

Journal of Pharmaceutical Innovation, 2009

A simulation study was performed to investigate the statistical power of the revised US Pharmacop... more A simulation study was performed to investigate the statistical power of the revised US Pharmacopeial Convention, Inc. <905> and Bergum's revised test acceptance limits for 95% confidence. In this simulation exercise, relatively small artificial lots of dosage units (20,000 U) were created to represent various probability distributions with increasing levels of defects. A simulation tool was developed to extract valid samples from each lot and perform the compendial test repeatedly for a minimum of 11,000 trials. This paper describes the results of these simulation trials.

Research paper thumbnail of Innovation in Pharmaceutical Experimentation Part 1: Review of Experimental Designs Used in Industrial Pharmaceutics Research and Introduction to Bayesian D-Optimal Experimental Design

Journal of Pharmaceutical Innovation, 2008

The concept of design space, as described in the ICH Harmonized Tripartite Guideline Q8 for Pharm... more The concept of design space, as described in the ICH Harmonized Tripartite Guideline Q8 for Pharmaceutical Development (Q8 Pharmaceutical development, ICH harmonized tripartite guidelines, in International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, 2005), was introduced to justify regulatory flexibility in pharmaceutical manufacturing operations. The basis for this concept is that advanced understanding of variables affecting product quality, obtained either through historical operation or demonstrated through process modeling, justifies replacement of traditional process targets with acceptable operational ranges. Process adjustments that allow operation within the region defined by the design space do not require regulatory oversight. Whereas there are many advantages to having the flexibility to operate within such ranges, the concept is only valid when the design space has been adequately described by appropriate experimentation. Given the complexity of pharmaceutical processes and the number of variables to consider in developing operational ranges, only a well-executed pro-gram of experiments, supported by appropriate statistical analyses, could provide the necessary information to truly capture a design space. Thus, the risk of employing a design space is that the model will be applied to a region outside of the approved design space, either through a false statistical inference or by omitting some important factor effects. This article presents a review of the experimental strategies typically employed to develop pharmaceutical processes with special emphasis on the assumptions and limitations of the approaches. An alternative strategy that provides an opportunity to build on previous information efficiently without requiring extraordinary skill in statistics, Bayesian optimal design, is introduced as an alternative to the classical approaches.