Pharmaceutical products development

Hussain AS, Yu X, Johnson RD. Application of neural computing in pharmaceutical product development. Pharm Res 1991 8 1248-52. 

C. C. Chan and E. Jensen, Overview of pharmaceutical product development and its associated quality system, in Analytical Method Validation and Instrument Performance Verification (eds. C. C. Chan, H. Lam, Y. C. Lee and X.-U. Zhang), Wiley-Interscience, Hoboken, NJ, 2004, pp. 1-10. 

Several large CROs have expanded their services into related markets such as contract product detailing, patient billing services and specialty pharmaceutical product development, manufacturing, and sales. The later situation can present a conflict of interest, if their own products are potentially competitive with the sponsor product candidates. Being both a CRO and a specialty pharmaceutical firm is awkward and represents an undesirable function in the contracting business. 

Hokanson, G. C., A Life Cycle Approach to the Validation of Analytical Methods During Pharmaceutical Product Development, Part II Changes and the Need for Additional Validation, Pfjarm. Tech., 18(16) 92-100, 1994. 

The approaches and strategies presented in this chapter are intended to overcome these issues for CE methods. Recendy a more advanced approach toward chromatographic method development was introduced in pharmaceutical product development that also is beneficial for CE methods. In the advanced approach (i) the voice of the customer is captured, (ii) key process input variables are identified, (iii) critical to quality (CTQ) factors are determined, (iv) several method verification tests are installed, (v) proactive evaluation of method performance during development is performed, (vi) continuous customer involvement and focus is institutionalized, and (vii) method capability assessment (suitability to be applied for release testing against specification limits) is established. 

To invoke a cliche, pharmaceutical product development is an art form (Fig. 3) (2). Pharmaceutical products and processes are developed primarily by recipe-driven trial-and-error methods. Typically, the first stage (drug synthesis) yields a drug substance in powder form. In the second stage... 

OVERVIEW OF PHARMACEUTICAL PRODUCT DEVELOPMENT AND ITS ASSOCIATED QUALITY SYSTEM... 

New Excipient Development Timeline Linked to First Pharmaceutical Product Development Timeline... 

For the pharmaceutical product development scientist, there is clearly a need for objective information about the practical performance of different excipients and their various grades. In this chapter we set out to bring together the results of some of our ongoing evaluations of the physical and mechanical properties of excipients commonly used for the manufacture of solid oral dosage forms. In this particular article, we have chosen to focus on the fillers that are most commonly used in the manufacture of immediate release tablets microcrystalline cellulose (MCC), lactose, calcium phosphate, and mannitol (1). 

He has been responsible for pharmaceutical product development from exploratory development, preclinical, preformulation, and drug delivery platform technologies, formulation, process, and scale-up manufacturing toward commercialization. 

I am pleased to have Dr. Alfred Wachter join me as coeditor of this edition. He was formerly head of Pharmaceutical Product Development for the CIBA Pharmaceutical Company in Basel, Switzerland, and also spent a number of years on assignment in Asia for CIBA. Fred brings a very strong international perspective to the subject matter. 

Hokanson, G. C. A life cycle approach to the validation of analytical methods during pharmaceutical product development, part I The initial validation process. Pharm Tech 118-130 (Sept. 1994). 

Baertschi SW. The Role of Stress Testing in Pharmaceutical Product Development, presented at the American Association of Pharmaceutical Scientists Midwest Regional Meeting, Chicago, IL, May 20, 1996. 

Pharmaceutical Product Development In Vitro-ln Vivo Correlation, edited by Dakshina Murthy Chilukuri, Gangadhar Sunkara, and David Young... 

TABLE 2.3 New Initiatives on Pharmaceutical Product Development by Regulatory Agencies... 

Miyauchi, A. (1998). A commercial application of EBA in a veterinary pharmaceutical production. Development of recombinant epidermal growth factor production process using Bacillus brevis. Int. Conf. Expanded Bed Adsorption, 2nd, Napa Valley, CA, 1998, Abstr. 0.03. 

Zhao, C., Jain, A., Hailemariam, L., Suresh, P., Akkisetty, P., Joglekar, G., Venkatasubra-manian, V., Reklaitis, G.V., Morris, K., and Basu, P. (2006), Toward intelligent decision support for pharmaceutical product development, I. Pharm. Innovation, 1, 23-35. 

Hussain, A. S., Shivanand, P., and Johnson, R. D. (1994), Application of neural computing in pharmaceutical product development Computer aided formulation design, Drug Dev. lnd. Pharm., 20,1739-1752. 

Tests in the target organism are crucial, but the importance of animal and in vitro models for pharmaceutical product development should also not be neglected. In most cases the available range of models and in vitro tests needs to be extended for the development phase, because the models used in research are not adequate or not sufficient. Considering the fact that all potential facets and variations of a new active component (different protein conformations, concentrations and formulations, the mode of action, immunology, pharmacokinetic, safety and efficacy under various conditions) may have to be studied, the availability of models can be an important asset for a fast and cost-effective product development. 

This book is an attempt to summarize information on the fundamentals of pharmaceutical product development for modern biomedicinal products and to combine these with specific recommendations for effective planning and management of applied research and development projects. A reasonable selection of information was necessary to avoid confusions by too many details. This inevitably leads to omissions and simplifications, particularly on patent and registration issues. The reader should bear in mind that these sections are primarily intended to... 

Pharmaceuticals, Mettler-Toledo GmbH, Schwerzenbach. [105f, 106f, IlOf] Schwarz, E. and Pfeffer, S. (1997). Use of subambient DSC for liquid and semi solid dosage forms—Pharmaceutical product development and quality control. J. Therm. Anal, 48, 557-67. [251]... 

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