New Product Applications

Blends of two samples of polyethylene in which each blend component was prepared with a single-site catalyst has also been reported [38] to provide an injection molding grade of HDPE with greatly improved environmental stress crack resistance (ESCR). A commercial grade of HDPE suitable for injection molding and prepared with a Ziegler catalyst was used as a control material. This data is shown in Table 6.17. 

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Significant advances in the synthesis, design and fundamental understanding of these viscoelastic materials have fueled the tremendous growth of the PSA product industry and opened up a variety of often demanding new product applications. There is every reason to believe this growth will continue since these products provide convenience and versatility for both the industrial and consumer market. 

The main feature of the harmonisation is guidelines and Common Technical Documents (CTD). The CTD gives a harmonised format and content for new product applications and in 2003 there was an agreement on implementation, in USA, Europe and Japan. 

As more than 95% of new medicines are worked out in the ICH regions the technical requirements for the safety, efficacy and quality of new medicines is determined at large by ICH technical guidelines. The application format for registration (marketing authorization) of new medicines in ICH and associated countries (such as Canada, Switzerland and Australia) has to follow The Common Technical Document (CTD) which provides harmonized structure and format for new product applications. This Common Technical Document is divided into four separate sections and 5 modules (see Fig. 1). The four sections address the application organization (M4 Organization), the Quality section (M4Q), the... 

FDA inspects manufacturers of drugs, biologies, and medical devices in relation to the submission of an NDA or BLA application. But independent of application reviews, it also inspects manufacturers periodically for compliance with such agency regulations as cGMPs. Some manufacturers are also inspected because they have a record of being out of compliance with FDA regulations. On some occasions, periodic compliance inspections coincide with inspections for NDA or BLA new product applications. 

Effective communication, both within the applicant s organization and with the FDA review team, is an integral part of planning any submission. It has been demonstrated consistently that the success of a new product application is dependent on the effectiveness of the organization s submission team and the working relationship developed between this group and the agency review team. 

Postmarketing Reporting of Adverse Drug Experiences, March 1,1992. Center for Drug Evaluation and Research (CDER). Guidance for Industry. Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review, Nov. 1,1992. 

In the same dictionary, innovation is defined as the introduction of novelties the alteration of what is established and something newly introduced a novel practice or method . We can re-interpret this for the industrial environment as the introduction of new products, application processes or services to the market based on prior knowledge . Thus, innovation in R D is the generation of new ideas, which can then be used to produce these new products, processes and services. It should be obvious that this is an activity that does respond directly to planning. Certainly, at the development end of the innovation chain, rigorous planning is a prerequisite and this is covered in Section D on Project Management. 

There are several other key components to trial execution that will require special attention subject recruitment, the informed consent, IRBs/IEC review product accountability, adverse experience and adverse reaction reporting, financial disclosure, and record retention. Each is critical in the overall success of a clinical trial. If one of these is not handled or processed appropriately, the clinical trial will not be used in support of a new product application. Many of these components have been discussed previously in the context of monitoring. Adverse experience and adverse reaction reporting, informed consent, and IRB/IEC are detailed in Chaps. 11 and 20. The remaining key components relative to managing clinical trials will now be addressed. 

Common Technical Document for the Registration of Pharmaceuticals for Human Use (CTD) ICH, 2001) The CTD provides for a harmonized structure, content, and format for new product applications. The document is divided into four separate sections. The four sections address the application organization (M4 organize), the quality section (M4Q), the safety section (M4S) and the efficacy section (M4E) of the harmonized application. Drug metabolism and pharmacokinetic data should be summarized in the safety section that includes the nonclinical overview, nonclinical written summaries, and nonclinical tabulated summaries. More specifically, in Section 2.6.4.S metabolism (interspecies comparison) of the written summaries, the following data should be included ... 

We will look at five specific FDA guidance documents the formatting of the statistical section of an application, the integrated summary of effective-ness, statistical review template, conducting a safety review for a new product application, and guidance for DILI. ... 

FDA. Reviewer guidance Conducting a clinical safety review on a new product application and preparing a report on the review. Washington, DC FDA 2005. 

The process technology for PP manufacture has kept pace with catalyst advances and the development of new product applications and markets. In particular, the... 

Although ethylene/1-olefin copolymers were well documented in the late 1950s with the discovery of the chromium-based Phillips catalyst and the titanimn-based Ziegler catalyst, it was the discovery of metallocene-based single-site catalysts and the constrained geometry catalyst system that significantly increased the various types of new ethylene-based copolymers that are available for commercial applications. These new catalysts created new products, applications and markets for the polyethylene industry. 

It is not xmusual during the early stage of a product growth cycle for product demand to exceed product supply as new product applications are rapidly introduced. This was the case for the polyethylene industry. 

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