Drug life cycle

The availability of a new class of efficient separations technology for chiral drugs can have an impact on other business issues now at the forefront of the pharmaceutical industry. For example, the strategy of better drug life cycle management can be... 

Fleming E, Ma P. Drug life-cycle technologies, Nature Reviews Drug Discovery 1 751-752 (2002). 

This can also be called the pre-marketing phase of the drug life cycle. It should be noted that although all this is necessary, it is certainly not sufficient for commercial success. 

Health Economics in the Drug Life Cycle—Achieving success in drug discovery, development, reimbursement, and marketing. Urch Publishing Ltd. January 2003. 

Figure 25.5 Custom manufacturing gateways along the drug life cycle.

Table 12.1 Drug life cycle stages and regulatory requirements...

Drug life cycle stage Regulatory requirements/Guidelines... 

SEP increases since the implementation of the SEP Drug life cycle stages and regulatory requirements Donor support of local industry through contracting for local health supplies Zimbabwe Finance capabilities at the firm and financial institution levels... 

The exact mechanism of action of thiabendazole (Mintezol) is unknown. This drug appears to suppress egg or larval production and tiierefore may interrupt die life cycle of the helminth. Thiabendazole is used to treat threadworm. Thiabendazole may cause hypersensitivity reactions, drowsiness, and dizziness. 

Simulations may also be used to inform understanding of market dynamics and life cycle management and to aid in understanding the ways in which reference pricing and parallel trading may influence the best sequence of drug... 

FIGURE 84-1. Life cycle of HIV and targets for antiretroviral drugs. (From Fletcher CV, Kakuda TN. Human immunodeficiency virus infection. In DiPiro JT, Talbert RL, Yee GC, et al, (eds.) Pharmacotherapy A Pathophysiologic Approach. 6th ed. New York McGraw-Hill 2005 2258, with permission.)... 

One way to view the issue of sample throughput is to define the steps required for the process. If we add an in-life portion to the assay time for an ADME/PK study, the term drug metabolism discovery cycle time (DMDCT) applies to the amount of time from the beginning to the end of a study. Thus, DMDCT = in-life cycle time + assay cycle time. 

To assist the reader with the question of which dissolution test to apply when the first part of this chapter is divided into two primary sections—one dealing with drugs that have few or no solubility problems, in which case developing dissolution tests at all stages of the product life cycle... 

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