Extension line

Although 16 different crystalline modifications have been identified (24,25), the a-pentahydrate is the stable form below 48°C. Solutions of sodium thiosulfate in the absence of seed crystals can be easily supercooled below their normal crystallisation temperatures. The dotted line extension of the dihydrate phase in Figure 1 is an indication that, if supercooling takes place below this line, solutions normally giving the pentahydrate may form the dihydrate [36989-90-9] s1ste2id. 

The first of these can be used when a product is to be marketed in a single country. It can be used for any type of application except for certain types of biotechnology-based items. Having been approved in one country, in most cases an application to a second country will trigger the Mutual Recognition procedure in other concerned countries. There are certain exceptions to this, e.g., where a product has different summaries of product characteristics (SmPCs) in different countries, and these have not been subjected to a harmonization procedure. Line extensions to such products could also remain subject to national procedures. 

Muro Pharmaceutical, Inc. introduced a new line extension, Prelone Syrup 5 mg/ 5 mL (Prednisolone steroid), to the existing product, Prelone 15 mg/5 mL. Because only one strength of Prelone had been available for many years, it was a general practice to prescribe Prelone Syrup without specifying the strength. 

A pharmaceutical product has a limited life cycle and once the patent expires, generic competitors rapidly enter the market. There are a number of strategies that companies can adopt to try to extend patent life. These include line extensions, reformulations, combination products or switching to over-the-counter (OTC) sales. In the United States, but at this point not the European... 

For applications to be processed via the centralised procedure, the CHMP appoints one of its members to act as rapporteur for the coordination of the evaluation of an application for a marketing authorisation. The CHMP may, and usually does, also appoint a second member to act as co-rapporteur. For line extensions, the CHMP will decide on the need for appointment of a corapporteur on a case-by-case basis. All members have an equal opportunity to act as the rapporteur or co-rapporteur, and therefore the CHMP members are invited to express their preference regarding rapporteurships in writing in advance of the meeting at which rapporteurs are appointed. Rapporteurs are usually appointed at every other meeting to facilitate the decision making process as regards (co)-rapporteurships. 

Sooner rather than later, CTD-formatted dossiers should also be made acceptable for other types of products (e.g. generics, line extensions, herbals, radiopharmaceuticals and blood... 

Solid oral dosage forms containing new chemical entities (NCEs) are commonly formulated into tablets or capsules as their first market image formulation. Subsequent drug product line extension development on these NCEs may evaluate more specialized drug delivery systems. Dissolution testing of standard oral tablets or capsules will commonly utilize the paddle or basket apparatus. In this chapter we focus primarily on the development and subsequent validation of dissolution testing methods that use these two devices. 

Analytical testing (preformulation, stability, product release) is a core component of pharmaceutical operations from early R D through manufacturing of the commercial product. The original analytical methods are usually developed by the pioneer pharmaceutical firm and transferred to the provider. In some cases, the early methods are only preliminary methods and are not sufficiently robust to test the quality of downstream (clinical, commercial, and line extension) products and facility quality practices (cleaning validation). In those situations, the supplier is often asked to develop new methods, and in some cases those methods are transferred back to the client. In either scenario, the transfer of validated analytical methodology consists of the following four main tasks [52] ... 

Until only a few years ago, a company intending to market a new drug product in the EU would submit a national NDA in each country in which authorization was sought. While national procedures may still be used in limited situations, such as for approval of product line extensions, a firm must choose the mutual recognition or centralized system. (We will not discuss the approval process for generic products.)... 

We must qualify this last statement in the case of assignments that are related to but not identical with trickle-down the line extensions of fine fragrances. When perfumes have to be developed for a soap, a body lotion, deodorant, or shower gel that are to be sold alongside a fine fragrance carrying the same name, closeness to the original... 

Both line extension assignments and the trickle-down approach involve the art of perfume adaptation, of replacing components of the original composition by others that are technically more suitable for the application in point, or less expensive. We will deal with the problems of adaptation in a later section of this chapter. 

Creative assignments such as trickle-down exercises or developing fragrances for line extensions involve the adaptation of a fragrance for-... 

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