Therapeutic groups

In order to be approved, an NDA must include data which demonstrate that the dmg is both safe and effective. Each NDA is assigned to a division within ODER for consideration and adnunistrative control, and then assigned to the appropriate therapeutic group within the division for review. The primary team of reviewers typically consists of a physician, a pharmacologist or toxicologist, and a chemist. 

Identification of the medicinal product (name, form, strength, pharmaco-therapeutic group)... 

The results showed that the compounds studied with more frequency in the aquatic environment, and of which, logically, there is more information, are the antibiotics, analgesics and anti-inflammatories (like diclofenac, ibuprofen, naproxen, acetylsalicylic acid, and paracetamol), as well as the p-blocker atenolol. In the category of antibiotics, several families are included, like the macrolides (erythromycin), the fluoroquinolones (ofloxacin and ciprofloxacin), sulfonamides (sulfamethoxazole), penicillins (amoxicillin), the metronidazol, and trimethoprim. Other therapeutic groups also widely studied and frequently found in the environmental waters are the lipid regulators (gemfibrozil and bezafibrat), antiepileptic carbamaze-pine, and antidepressants (diazepam, fluoxetine, paroxetine) (see Table 3). 

An accurate measure of the apparent causes of the evolution of pharmaceutical expenditure could be obtained by taking chain-linked Laspeyres price indexes for each therapeutic group with a suitable level of disaggregation. In this situation, ideally we would have monetary measures of willing-... 

Generally it can be observed that price elasticity is low, a trend that is aggravated by the fact that in most health systems the consumer does not pay the totality of the price. Some authors state that the elasticity of substitution between medicines in different therapeutic groups can be almost nil. The existence of insurance is an incentive for greater consumption and facilitates the application of higher prices (moral hazard). 

The drug price intervention system in place in Spain since 1991 is based on the fixing of the price of each product by the health authorities, calculated according to its cost . This system allows for the possibility of excluding certain products or therapeutic groups from the price intervention system. It would be desirable to apply this exclusion principle to those products that are subject to a reasonable level of competition. Briefly, the main features of the Spanish system of price regulation are as follows ... 

Second, we analyse the position of the leading products in the different therapeutic and generic drug markets. Our aim is to evaluate the extent to which the leaders achieve dominant positions in each market. Positions of dominance are shown in terms of the market share of the most frequendy prescribed active ingredient, product or presentation in its therapeutic group of active ingredients, products or presentations, called v, in which g = 1,2,..., G are mutually exclusive groups. 

Australia (1998) Coverage six therapeutic groups, especially coronary diseases and ulcers (pharmacological equivalence) RP the lowest in each group Reviewal every four months... 

British Columbia (1995) Coverage products with different active ingredients within the same therapeutic group RP generally the lowest in each group Reviewal ad hoc... 

To sum up, in Europe we have an enormous variety of types and formulas of co-payment, which have developed gradually over time and allow us to draw some conclusions with regard to their effectiveness. In practice, the percentage of pharmaceutical expenditure borne by patients varies greatly for different countries and therapeutic groups.20... 

The form and the process of regulation offer a whole range of possibilities, from hierarchy to the market, via various hybrid situations. The efficient regulator will be that which succeeds in developing an intervention that provides a better response to the characteristics of the transaction. For their part, lobbies are characterized by their nationality, size, reputation and experience. The empirical application considers a sample of active ingredients in three therapeutic groups for which the author identifies the regulatory forms adopted in each of the two countries. 

In order to analyse the balance in view of the threat of exclusion from public financing, the author devises a demand equation with a two-stage budget allocation. The first step is to choose a therapeutic group, and the second is to choose the differentiated products. The co-payment acts as the price. The main conclusion is that when the product is included in public financing the health service can receive a discount if the political decisions are price-sensitive and the fixed cost of market entry in the event of inclusion is lower than the fixed cost of exclusion. In his study of price-cap regulation, the author insists that the mechanism should be continued in the long term, and that therefore it is necessary to account for the entire lifetime of the product and consider a discount factor. All this takes as its point of departure Abbott s 1995 model. 

Therapeutic group Compounds CAS Number Sampling campaings First Second (2005) (2006-2008) ... 

ATC therapeutic group based on the World Health Organisation Nordic Anatomical Therapeutic Chemical Classification Index (ATC) codes. 

Therapeutic group Compound Maximal concentration detected (ng/L) References... 

A prescriber may apply to the HIC for a TCP exemption for an individual patient for a particular product, if adverse effects or reactions are expected to occur with all of the benchmark priced products or the transfer to a benchmark priced product would cause patient confusion leading to problems with compliance. Pharmacists may not substitute between different chemical entities in a therapeutic group. 

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