Thesis. 1979. Ph.D.--Massachusetts Institute of Technology. Dept. of Economics. / MICROFICHE COPY AVAILABLE IN ARCHIVES AND DEWEY. / Bibliography: leaves 176-179. / This thesis examines the effect that federal regulation of the product quality of new drugs (through safety and efficacy requirements) has had on the flow of new drugs onto the market place. The approach is to econometrically estimate these effects using disaggregated therapeutic class data from the 1970's. There are two primary estimations. First, the current effects of regulation on the production function relation between introductions and research expenditures are estimated. Second, the indirect effects of regulation on research effort are estimated in a research expenditures equation. These estimates are then combined to estimate the overall effect of regulation on introductions in the current era. In addition to the basic estimations described above, several important subsidiary issues are treated in the thesis. One is a discussion of the decline in new drug introductions of the 1962 era in terms of its individual therapeutic class components. This discussion gives strong support to the position that nonregulatory factors precipitated that decline in the rate of product introductions. Also, the project selection process of major pharmaceutical companies is examined in great detail. That discussion, and some econometric tests of hypotheses generated, clearly demonstrates that in order to predict how firms will respond to changes in environmental factors affecting profitability, one must first understand how firms collect, evaluate, and apply information concerning those factors. / Ph.D.

Thesis (M.S.)--State University of New York at Binghamton, Thomas J. Watson School of Engineering and Applied Science, Department of Systems Science and Industrial Engineering, 2009. / Includes bibliographical references.

This investigation attempts to examine the influences of validation on pharmaceutical processes especially at a new manufacturing facility that has to meet international requirements, and fulfil a cost effective business strategy. At Aspen Pharmacare, a pharmaceutical organisation, there are two manufacturing facilities situated adjacent to each other, one new and one old. The new facility creates ideal opportunities to supply products to local and international markets. The investigation compares legal requirements from local and international regulatory authorities. Validation and qualification practices as well as the problems encountered during the different phases are discussed. Particular attention is given to the validation approach at the new Aspen facility. Problems and proposed solutions relating to the design review, installation, operational, and performance qualification are discussed. Validation of analytical methods for cleaning analysis, cleaning validation of equipment, and optimisation of some tablet manufacturing processes are described. Statistical evaluations of analytical results are included to find the optimum conditions for integrating new personnel with new processes and equipment. A business model reviews the cost of non-conformances of the enalapril maleate 10 mg tablets manufactured at the two manufacturing facilities. Finally the dissertation proves that validation is not only a regulatory requirement but that it also provides benefits such as adding value to the business, and ultimately reducing the cost of medicines.

Thesis (MBA)--Stellenbosch University, 2003. / ENGLISH ABSTRACT: With globalisation and the accompanying increase in international trade there is a great drive towards performing risk assessments on the quality of products. Such assessments are of particular importance within the food and drug industry, so much that this approach is also being adapted by the FDA in their analysis of the quality of products and probable risks to it. The pharmaceutical industry is heavily regulated to reduce or eliminate the production and distribution of poor quality products. Pharmaceuticals have to be of high quality as people's lives depend on it. Many pharmaceutical companies import raw materials from international manufacturers or international agents. In most cases the raw material or the products have to go through a long and complicated supply chain. The more parties involved in the supply chain, the greater the risk to product quality. Supply chain partnerships have therefore become critical to manage these risks to product quality throughout the supply chain. In order to manage risks to product quality, it has become vital to perform product quality risk assessments, especially through the supply chain. In this study the Failure Mode Effect Analysis (FMEA) is used to perform a risk assessment of risks to product quality throughout the supply chain. To obtain the criticality of the risks the Failure Mode Effect and Criticality Analysis (FMCEA) is applied. Quality improvement systems which contribute towards managing the risks to product quality are also discussed in this report. By managing quality risks to pharmaceutical products along with using quality as a strategy, the pharmaceutical company contributes towards improved health for patients as well as customer satisfaction, business success and excellence. / AFRIKAANSE OPSOMMING: Die toepassing van die analise van die risiko op produkte is vinnig besig om te vermeerder. Die FDA gaan dit toepas in hulle analise van die kwaliteit van produkte en die risiko wat daarmee gepaard gaan, in die voedsel en medisyne bedryf. Die farmaseutiese industrie word baie streng gereguleer om te verhoed dat die produksie en distribusie van swak kwaliteit produkte ervaar word. Farmaseutiese produkte moet van hoë gehalte wees, omdat die gesondheid van pasiënte daarvan afhang. Baie farmaseutiese maatskappye bestel rou materiale van oorsese makelaars en in baie gevalle moet die rou materiale deur 'n lang en gekompliseerde voorsieningsketting gaan. Hoe meer agente betrokke is, hoe hoër word die risiko met respek tot die kwaliteit van die produk. Die voorsieningsketting speel 'n kritiese rol om te verseker dat risikos beheer kan word, omdat elke party verantwoordelik is vir die lewering van kwaliteitsprodukkte. Om te verseker dat risikos beheer word, het dit belangrik geword om risiko analise te doen op die kwaliteit van produkte, veral wanneer in die voorsieningsketting. In hierdie studie word die "Failure Mode Effect Analysis (FMEAJ' gebruik om 'n risiko analise te doen met betrekking tot risikos op 'n produk se kwaliteit wanneer in die voorsieningsketting. Die "Failure Mode Effect, and Criticality Analysis (FMECAJ', word ook toegepas om te bereken hoe krities die risiko is. Verbeteringstelsels wat bydra tot die beheer en kontrole van risikos vir produk kwaliteit word ook in hierdie studie bespreek. Deur die risikos te beheer op die kwaliteit van produkte, dra die farmaseutiese maatskappy by tot beter gesondheid vir pasiente, en verseker klient satisfaksie en suksesvolle besigheid.

published_or_final_version / Medical Sciences / Master / Master of Medical Sciences

Thesis (MTech. degree in Pharmaceutical Sciences)--Tshwane University of Technology, 2009. / Quality control procedures are vital in the pharmaceutical industry to guarantee the authenticity and quality of products. A major challenge in quality assurance of herbal material is the vast variation of active constituents in plants from the same species. As a result of this variation, the selection of only a few compounds as criteria for quality control is inadequate. Pelargonium (P.) sidoides is indigenous to South Africa and highly valued by traditional healers as a remedy to treat coughs, upper respiratory tract irritations and gastrointestinal conditions. An ethanolic extract of P. sidoides is used in the proprietary herbal tincture known as Umckaloabo®. The composition and concentration of polyphenols are parameters which determine the quality of this herbal medicine because it provides several therapeutic benefits in the non-specific medicinal treatment of infectious diseases. Despite the commercial development of P. sidoides very few studies have been conducted to document the full phytochemical range of variation for natural populations and no study has been published on the development of a fast accurate quality control method for the validation of raw material.

University of Macau / Institute of Chinese Medical Sciences