Therapeutics, categories

To evaluate the performance of the descriptors one needs a database of compoimds for which the biological activities are known, e.g.. either the MDDR or the NCI databases. Queries are selected that are typical of a drug-hke molecule and from therapeutic categories that... 

J. Hardcastie, ed., Pharmaprojects (Therapeutic Categories, Main Volume), Vol. 10, PJB PubHcations, Richmond, UK, 1989, p. a616, and monthly updates. 

Table 3.1 The top 15 therapeutic categories on the basis of new products in the regulatory process in the United States in 2006.

DiMasi JA et al. Research and development costs for new drugs by therapeutic category a study of the US pharmaceutical industry. Pharmacoeconomics 1995 7 152-169. 

Drug Therapeutic category enzyme in the major pathway for metabolism of the drug Frequency of poor metabolizer genotypes, % ... 

Clinical Evaluation by Therapeutic Category Principles for Clinical Evaluation of New Antihypertensive Drugs... 

Efficacy Nine topic headings—Clinical Safety, Clinical Study Reports, Dose-Response Studies, Ethnic Factors, GCP, Clinical Trials, Clinical Evaluation by Therapeutic Category, Clinical Evaluation, Pharmacogenomics total of 18 guidelines... 

DiMasi JA, Grabowski HG, Vernon J. R D costs and returns by therapeutic category. Drug Inf 2004 38 211-23. 

At one end of the spectrum, the event may be a simple dosage problem which could be an error on the part of the prescriber or an unanticipated hypersensitivity for that particular patient. At the other end of the spectrum, is an uncommon, serious adverse reaction not revealed in premarketing clinical trials. Somewhere between those two extremes are more or less serious adverse events which are not entirely unexpected but appear to be more common than is accepted for comparable products in the same therapeutic category. This maybe a real increase in frequency or may be due to patient selection bias. The later has arisen with new products which claim a lower incidence of certain adverse reactions which encourages doctors to precribe them preferentially for patients who have suffered such reactions with older products. 

As part of primary care, general practitioners (GPs) are free to prescribe virtually any medicine they consider desirable for the patient, with the exception of medicines in certain therapeutic categories covered by the 1985 and 1992 Selected List restrictions (see below). 

Compound or Class Botanical Source Therapeutic Category/Use... 

Lead Compound Compound Class of Compound Therapeutic Category / Use... 

The shift to a more science-based process, however, is not fully complete. It occurred more rapidly in some therapeutic categories than in others, and in some pharmaceutical companies than in others. These two dimensions are, of course, not independent for companies whose work is more heavily concentrated in areas where science-driven activities have taken hold more fully and have in turn adopted the new approach more quickly. A striking feature about this technological shift has been the considerable heterogeneity in the adoption process. The diffusion of this change has not been rapid or complete. 

A third basic option available in the case of some therapeutic categories is to develop an over-the-counter version of a product subject to patent expiration. The strategy has been employed for example for anti-inflammatory pain relievers such as Motrin and Naprosyn, anti-ulcer therapies such as the H2 blockers Tagamet and Zantac, proton pump inhibitors such as Prilosec, and in several other therapeutic categories. However, a shift to OTC status requires approval by the FDA that the drug is safe for self-medication (Juhl 2000 McCarran 1991 Schweitzer 1997). A company will normally need to submit new clinical trial evidence to that effect. If approved by the FDA, the company receives a three-year exclusivity period for its OTC product in recognition for the new clinical trial work. 

A key driver of success in the OTC market is the ability to capitalize on the brand loyalty enjoyed by the prescription product. The number of category shifts to OTC status approved by the FDA has grown over time. At the same time, there are many therapeutic categories where this is not as viable strategy because they would not meet the FDA s requirement on safety for self-medication (e.g., mental health and cancer drugs). The FDA has also declined several product requests for shifts to OTC status, such as anticholesterol drug agents. 

In spite of intertemporal differences in the number of NMEs introduced, the cumulative number of NMEs launched in Taiwan increased steadily. Between 1985 and 2002, 821 NMEs were introduced in Taiwan (Fig. 13.2). On average, nearly 46 NMEs were introduced into Taiwan s market annually." The three largest therapeutic categories were alimentary tract and metabolism, cardiovascular system, and nervous system, each... 

Bulk procurement encompasses that medicines orders are pooled together, that the focus is on the list of priority medicines and that duplication within therapeutic categories is avoided as much as possible. This will result in larger procurement volume and will increase purchasing power. Bulk procurement can be through cooperation of facilities in a country, but positive experience has also been reported from arrangements between states. 

Therapeutic Categories. This classification is important for the pharmaceutical industry, as many companies specialize in selected therapeutic classes. The ranking of the major ones is shown in Table 11.5. Together, they account for 30% of global drug sales. 

These reflections discredit the conventional wisdom that drug prices are open-ended. At least for we too drugs, there is competitive pressure within the same therapeutic category. 

A pragmatic approach to resolve the problem is to allow the supplier to use the IP outside the area of the customer s direct interest. This can be defined, for instance, by a therapeutic category. Thus, the supplier is restricted to use the IP for the synthesis of PFCs outside the specific therapeutic category of the drug that is the object of the joint project. 

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