Product development utilization

Product development for biological pharmaceuticals might appear as a simple continuation of a research project after a sufficiently effective compound has been identified. From a scientific point of view there is no clear distinction between research and development. Until the clinical phase, product development utilizes the same basic skills and methods and - to a great extent - the experience of the same people who did the research. However, the rules change considerably as soon as innovative research turns into conservative testing of quality, safety and efficacy and into analytical and process development. 

O.JVI. Scott Sons. The O.M. Scott Sons Co. (Scotts) has developed a series of coated products which utilize copolymer blends of vinyHdene chloride copolymerized with methyl methacrylates, acrylonitriles, methyl acrylates, and/or vinyHdene—vinyl chloride monomers. 

G. Lancaster, J. Damen, C. Orozco, and J. Moody, Global product and application development utilizing Insite technology, MetCon 94 Proceedings, USA, May 1994. 

The identification and quantification of potentially cytotoxic carbonyl compounds (e.g. aldehydes such as pentanal, hexanal, traw-2-octenal and 4-hydroxy-/mAW-2-nonenal, and ketones such as propan- and hexan-2-ones) also serves as a useful marker of the oxidative deterioration of PUFAs in isolated biological samples and chemical model systems. One method developed utilizes HPLC coupled with spectrophotometric detection and involves precolumn derivatization of peroxidized PUFA-derived aldehydes and alternative carbonyl compounds with 2,4-DNPH followed by separation of the resulting chromophoric 2,4-dinitrophenylhydrazones on a reversed-phase column and spectrophotometric detection at a wavelength of378 nm. This method has a relatively high level of sensitivity, and has been successfully applied to the analysis of such products in rat hepatocytes and rat liver microsomal suspensions stimulated with carbon tetrachloride or ADP-iron complexes (Poli etui., 1985). 

The utility and value of the ability to solution deposit inorganic materials must be promoted and discussed in a variety of forums, both technical and nontechnical. In general, the technical forums are required to share observations during experimentation as well as product development. Forums such as workshops, symposia, ad hoc consortia, and study groups are necessary to provide an environment for engineers and scientists to disclose and discuss problems and solutions. The nontechnical forums are important to excite the mass... 

Parasitoid wasps are the most widely studied group of insect parasites. Female wasps lay an egg(s) on or in an insect and the progeny develop utilizing that insect as their sole food source, eventually killing the host. Female parasitoids tend to be host specific and typically exploit a specific host immature life stage (e.g., egg, larvae, or pupae). Most parasitoid wasps are relatively small. Females actively seek out multiple hosts and can find and parasitize host insects in cryptic habitats. There is a wide range of species that attack stored-product insects and a considerable body of research on these natural enemies, only some of which are covered here [see Godfray (1994) for more information on parasitoids and Brower et al. (1995) and Scholler and Flinn (2000) for reviews of information specifically on stored product parasitoids]. 

The third and last major driver is to develop/maintain agricultural activities and to respond to agriculture hazards. Such development could consist of promoting the production and utilization of local bio-resources for food, fuel, electricity and material production. It could also consist of the electrification of remote rural areas by means of micro-hydropower, wind or solar energy. 

Hard shell capsules occupy a central role in drug product development and manufacture, ranking second behind compressed tablets in frequency of utilization in drug delivery. In product development, such capsules are often the first dosage form for any orally administered drug substance. Although the expectation may be that the final marketed form will be a compressed tablet, firms may consider using the capsule as the first marketed form to shorten the overall development cycle. 

Historically, the time period for pharmaceutical drug product development is usually on the order of 10 to 15 years. However, with the ever-increasing competition between pharmaceutical companies, it is of utmost important to reduce the time utilized to complete the development process. 

The introduction of the HP substituent did increase the water solubility of the CD 40-fold over the parent P-CD while retaining much of the solubilizing power of the P-CD cavity. The new derivative did demonstrate improved renal safety allowing for the utilization of this CD in both oral and parenteral product development. 

---