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Such a strategy would identify clinically relevant predictors that may exist at the earliest possible opportunity, allow these predictors to be integrated into subsequent clinical development and provide mechanistic insights into drug disposition and patient-specific factors that influence response, therefore paving the way towards more personalized medicine.
The data obtained from this pilot study might be used for the design of any subsequent clinical development programme.
This in vivo study was designed to provide data to support the subsequent clinical development of PF-05280014 as a potential biosimilar.
29, 30 The significant anti-MM activity of bortezomib observed in preclinical studies provided the impetus for subsequent clinical development of the drug.
Cellular assays are critically important for the identification and optimization of potent inhibitors suitable for in vivo pharmacology studies and subsequent clinical development.
Furthermore, of particular importance for the subsequent clinical development of ONYX-015, it was noted that efficacy against this tumour was significantly enhanced when the virus was combined with the chemotherapeutic agents 5-FU or cisplatin (Heise et al, 1997).
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It applies to new drug substance and drug product during clinical development and subsequent applications for marketing, as well as specific cases of post-approval submissions of marketed products and to new marketing applications.
Confirmation of this hypothesis, and the development of subsequent clinical strategies for limited these infections, would require additional comprehensive surveillance efforts among communities in China and elsewhere.
Such analyses have been pivotal to the development and subsequent clinical use of drugs such as trastuzumab and imatinib, and are now included wherever technically feasible in both Phase I and Phase II trials.
The BiomarCaRE consortium measures success not only in terms of development of novel risk estimation models and their subsequent clinical utility, but also in terms of the development of novel, innovative technologies.
Taken together, our data indicate that important phenomena are related to the development of active tuberculosis and subsequent clinical cure.
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