Paint by number - Wikipedia, the free encyclopedia. Paint by number (or painting by numbers) describes kits having a board on which light blue or gray lines indicate areas to paint, each area having a number and a corresponding numbered paint to use. The kits were invented, developed and marketed in 1. Max S. Klein, an engineer and owner of the Palmer Paint Company of Detroit, Michigan, and Dan Robbins, a commercial artist. This public response induced other companies to produce their own versions of paint by number. The Craft Master paint- kit box tops proclaimed, . Artifacts which establish Max Klein as the inventor and main merchandiser of these items are part of the collection. After O'Donoghue's death in 1. Smithsonian Institution's National Museum of American History exhibited many key pieces from O'Donoghue's collection, now owned by Speegle, along with works from other collectors in 2. Retrieved May 2. 7, 2. Paint by Number: The How- to Craze that Swept the Nation. Washington, D. C.: Smithsonian Institution, National Museum of American History in Association with Princeton Architectural Press, 2. Eligible for FREE UK Delivery. Painting by numbers is the ideal introduction to painting for the young. Painting by numbers has been a popular occupation for many years. On Online-Games-Zone.com you will find tons of free online games, which you can play right in your browser. All online games are for FREE and you can play them online, so you never need to install any programs on your personal.
PAINT BY NUMBERS - Home Some of us discovered an innate talent for visual communication through painting. Others of us found that the creative tendencies were focused in other areas, maybe music or some other form of expression.
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Transdermal Patch Materials ManagerTransdermal Drug Delivery Systems Scale- Up and Post Approval Change workshop report findings to add important new product development and control principles. Important topics reviewed include ICH harmonization, quality by design, process analytical technologies, product and process validation, improvements to control of critical excipients, and discussion of Food and Drug Administration’s Guidance on Residual Drug in Transdermal and Related Drug Delivery Systems as well as current thinking and trends on in vitro–in vivo correlation considerations for transdermal systems. Key words: CMC, ICH, quality by design (Qb. D), residual drug, TDSINTRODUCTIONIn 1. American Association of Pharmaceutical Scientists, the Food & Drug Administration (FDA), and the United States Pharmacopeia (USP) collaborated to organize a workshop to explore the Scale- Up and Post Approval Change (SUPAC) principles for Adhesive Transdermal Drug Delivery Systems (TDS). The 1. 99. 7 SUPAC Workshop was the fourth in a series. Previous workshops covered other major pharmaceutical dosage forms; namely, oral solid dosage forms, extended release oral dosage forms, and semisolid and liquid topical dosage forms. The findings of the Transdermal Dosage Form Workshop followed the established SUPAC format of discussing the impact of (1) formulation or compositional changes, (2) process variable changes, (3) process scale changes, and (4) process site changes on the finished quality parameters of the transdermal products. Each area of change was further divided to reflect a hierarchy of “significance” and hence aided in establishing post approval change filing documentation. Although the findings of the workshop were published (1), unlike the outcome of prior workshop publications, the findings of the TDS Workshop did not result in the publication of a guidance document for use by both the pharmaceutical industry and the worldwide regulatory communities. For this reason, and also because the passage of time has introduced a number of important innovations and practices for use in both in- process and finished product control, it is timely to revisit and update the TDS Workshop findings. It is the hope of the authors that the updated information presented herein will be useful to those in the industry involved in the development of such products in presenting comprehensive Chemistry, Manufacturing and Controls (CMC) information to the USA and international regulatory bodies involved in the review of the TDS dossier. It is our further hope that the added information will lead to improved submission review times and approvals. While much of this information is not contained in any “official guidance document” it should nevertheless be a useful template for development of the original submission Pharmaceutics Development Report and aid in developing and justifying post approval change submissions as well. This whitepaper, sponsored by the Product Quality Research Institute, is a result of that thinking and is designed to engender additional discussion and commentary from other experts within the industry, academia and worldwide regulatory bodies. Although the document retains the spirit of the original TDS Workshop report it encourages the inclusion of new tools for the development, testing and control of TDS. The use of such tools and approaches as process analytical technologies (PAT), quality by design (Qb. D), in vitro–in vivo correlation (IVIVC) and excipient characterization should improve the robustness of the finished TDS and minimize or prevent unintended drift in the quality of the commercial drug product. REVIEW OF 1. 99. 7 TDS WORKSHOP REPORT FINDINGSIt is important to note that this whitepaper follows the same convention as the 1. TDS Workshop Report in that it reviews passive TDS only. While, we, the authors recognize the development and advent of active TDS, we feel that a discussion of these is best left for a subsequent whitepaper as the potential array of active systems is sufficiently broad to warrant its own discussion. Our definition of “passive” systems is any system that uses only nonfacilitated flux to deliver drug to the stratum corneum; that is, they exclude facilitated systems involving physical approaches such as mechanical force, electrical force, heat, and sound. We begin our 2. 01. TDS whitepaper with a brief review of the salient findings of the 1. Compositional Variables. In 1. 99. 7, it was recognized that “transdermal delivery systems typically contain, in addition to the drug(s), vehicles such as oils, alcohols, glycerin, water, fatty acid esters, surfactants, and may also contain fillers or excipients such as lactose, silicone dioxide, cellulose and cross- linking agents”(1). Furthermore it was recognized that “the TDS platform will contain several materials such as backing film, peelable liner, etc. The passage of time has certainly confirmed the truth of these statements and therefore argues in favor of an updating of the TDS Workshop principles based on current scientific thinking and capability. The authors have undertaken to do this in the section of this whitepaper entitled Improvements in Control of Critical Excipients (see “Glossary” for definition) wherein, both traditional excipients such as adhesives, viscosity agents, permeation enhancers as well as release membranes and other critical components are discussed. In regards to compositional variables, the 1. TDS Workshop Report concluded: “no a priori allowable range in excipients or platform materials was established by the workshop group” (1). The Workshop Report concludes: “. We note in this update that current technology allows improved identification, testing, and control of these critical compositional components. We also feel that the use of the current improved statistical design packages when combined with Qb. D approaches can afford substantial information about the allowable range of both minor excipients/components and those that are critical to the TDS. In addition, the use of these approaches when combined with improved testing techniques associated with PAT and enhanced finished product testing such as in vitro release can and should be used to facilitate review and approval of post- approval TDS CMC submissions involving compositional variables. Each of these techniques will be discussed fully in subsequent sections of this whitepaper. Process Variables. Since 1. 99. 7, substantial progress has been made by the pharmaceutical industry in the development of robust manufacturing processes. Techniques such as PAT are becoming more common in process control of manufacturing operations and in continual feedback and feedforward loops that adjust manufacturing operations thereby providing more consistent end product. In parallel, improvements to end- product testing have further increased the ability of companies to manufacture more consistent products and to monitor and control variation. Improvements to in- process and finished product testing were anticipated in the 1. Workshop Report which recognized the value of “control of unit operations” and the “characterization of the interplay between process variables and end- product performance”, especially, “drug delivery”, and “adhesion and wearability” (1). Our experts have elaborated on these control strategies in several sections of this whitepaper; notably those on process analytical technology approaches, and, improvements to test methods and controls of transdermal delivery systems. The latter topic provides an update on improvements to testing of drug flux, drug release, adhesion and tackiness, and, finally, in vitro/in vivo correlations approaches. In Vitro Tests. In vitro testing was common in 1. In this whitepaper, we review modernization of those techniques and the testing equipment used to monitor drug flux, drug release, adhesion, tackiness, and IVIVC. In Vitro/In Vivo Correlation. The 1. 99. 7 Workshop Report stated that three possible in vitro/in vivo correlations could be investigated; those being: in vitro release/in vivo skin permeation, in vitro release/in vivo bioavailability, and in vitro permeation/in vivo bioavailability (1). At that time, the authors concluded “there are very few recorded in vitro/in vivo correlations for transdermal systems. In fact, there is no published information indicating that an IVIVC has been established for any currently marketed passive transdermal system. Nevertheless, the authors of this whitepaper have included current thinking about the application of IVIVC in this update. CURRENT PRINCIPLES THAT AFFECT TDS DEVELOPMENTImpact of ICH Harmonization. ICH Q8(R2)—Pharmaceutical Development ICH Q8 encourages manufacturers to establish (during design/development) detailed understanding about their manufacturing process using Qb. D principles or other alternative methodology, and to define appropriate design space through assessment of process parameters that might impact product quality. Based on this detailed understanding, manufacturers would be able to better assess how future variation of critical material attributes and process parameters within their ranges (design space) could provide continuous assurance of product safety, quality, and efficacy (http: //www. Drugs/Guidance. Compliance. Regulatory. Information/Guidances/UCM0. 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