Hypothetical drug development

Figure 3.1 Hypothetical drug development pipeline, illustrating activities during a 12-month period. Three stages of drug development are indicated at the bottom of the figure. The corresponding milestones for each stage are indicated at the top of the figure. (Courtesy of Milestone Development Services, Newtown, Pa., USA.)...

TABLE 27.4 Discounted Cash Flows for a Hypothetical Drug Development Project ... 

This analysis suggests that future accelerated drug development activities require quantitative and qualitative process considerations. Industry experiences suggest that an iterative relationship, if not balance, between the two approaches exist. Whatever the case may be, future approaches to accelerated drug development is likely to continue to focus on the number of compounds/candidates in each development stage and on the rate at which they flow through the pipeline. These features are likely to combine elements of quantitative and qualitative process approaches. An extension of the previously described hypothetical pipeline is shown in Figure 3.4 to... 

COMPARATIVE PRECLINICAL DEVELOPMENT PROGRAMS FOR A HYPOTHETICAL DRUG AND BIOLOGIC... 

Consider a second hypothetical study in which three doses of a new antihypertensive drug are to be compared, and three groups of participants will each receive one dose. Such a study may be performed in earlier-phase drug development to determine the most appropriate dose for subsequent larger trials. The research question, research hypothesis, and null hypothesis in this case would be ... 

In an effort to develop an effective bioadhesive system for buccal administration, insulin was encapsulated into polyacrylamide nanoparticles by the emulsion solvent evaporation method [98]. Though nanoparticle formation ensures even distribution of the drug, pelleting of the nanoparticles was performed to obtain three-dimensional structural conformity. In addition, it was hypothetized that the pelletized particles will remain adhered to the mucosa, leading to good absorption. While studying bioadhesion and drug release profiles, it was found that the... 

All excipient background information is collected and stored electronically. This allows a user to access the data, manipulate the background traces based on the individual-excipient-to-dmg ratio in use, and make a prediction of the background to assess any potential issues for analytical development. For example, assume a formulation containing API and excipients at unit quantities as outlined in Table 14.3. Based on the quantity information, one can easily calculate the hypothetical individual excipient-to-drug ratio for each of the excipients. Nominal individual excipient-to-dmg ratios are listed from Table 14.1. By comparing the ratios, multipliers are obtained. Then, the data for relevant excipient background traces stored... 

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