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Showing 1 to 20 of 490 for “"drug development"”.

  1. Analytics for financing drug development

    Financing drug development has a particular set of challenges including long development times, high chance of failure, significant market valuation uncertainty, and high costs of development. The earliest stages of translational research pose the greatest risks, which have been termed the "valley …

    mit Repository record for Analytics for financing drug development (opens in a new tab)

  2. The drug development process : evaluation of PDUFA I/II and investigation into reducing drug development times

    … takes approximately eight years to bring a novel drug to market at an average cost of $800 million. Over the last ten years, the Food and Drug Administration (FDA) has helped to reduce the time from filing a new drug application (NDA) to granting marketing approval (i.e. the approval phase). …

    mit Repository record for The drug development process : evaluation of PDUFA I/II and investigation into reducing drug development times (opens in a new tab)

  3. The globalization of clinical drug development

    … clinical research of investigational drugs (also called clinical development) has traditionally been carried out in relatively developed countries in the North American, Western European, and Pacific regions. However, lately it has been widely reported that clinical trials starting now …

    mit Repository record for The globalization of clinical drug development (opens in a new tab)

  4. Financial model of the drug development process

    Thesis (S.M.M.O.T.)--Massachusetts Institute of Technology, Sloan School of Management, 1995.

    mit Repository record for Financial model of the drug development process (opens in a new tab)

  5. Project management and organization structure in drug development

    Thesis (Ph. D.)--Massachusetts Institute of Technology, Sloan School of Management, 1995.

    mit Repository record for Project management and organization structure in drug development (opens in a new tab)

  6. Protein and Ligand Dynamics in Drug Development and Resistance

    … therapeutics. In this work, we describe the development and implementation of novel techniques to study dynamics in proteins and protein-bound ligands, and discuss our investigation of the crucial role of dynamics in two disease-relevant systems.</p><p>First, we have expanded the utility of …

    duke Repository record for Protein and Ligand Dynamics in Drug Development and Resistance (opens in a new tab)

  7. Adaptive Designs and Methods for More Efficient Drug Development

    The development of a novel drug is a time-consuming and expensive process. Innovative trial designs and optimal sequences of clinical trials aim to increase the efficiency of this process by improving flexibility and maximising the use of accumulated information throughout the trials while …

    cambridge Repository record for Adaptive Designs and Methods for More Efficient Drug Development (opens in a new tab)

  8. Insights from biomolecular condensates into disease and drug development

    … of the role of condensates in disease and drug development could facilitate similar paradigm shifts, with early evidence suggesting that condensate dysregulation may be a feature of many diseases, and that therapeutics can modulate condensates. In the studies presented in this thesis, we …

    mit Repository record for Insights from biomolecular condensates into disease and drug development (opens in a new tab)

  9. Forecasting resource requirements for drug development long range planning

    … and manufacturing capacity requirements for a drug development organization. A pharmaceutical drug development group is responsible for designing the manufacturing process for new potential drug products, testing the product quality, and supplying product for clinical trials. The drug

    mit Repository record for Forecasting resource requirements for drug development long range planning (opens in a new tab)

  10. Engineering Liver and Cardiac Models for Drug Development and Regenerative Medicine

    … data for preclinical evaluations of drug-induced liver injury and cardiotoxicity, speeding up the notoriously lengthy and inefficient drug development pipeline, as well as fundamental investigations into stem cell behavior and cell-cell interactions. Tissue engineering is also …

    uic

  11. Topical pharmacokinetics for a rational and effective topical drug development process

    Topical drugs are not developed by the same process as oral drugs. The process is more uncertain and contains gaps. This leads to a poor discharge of risks before going to the clinical phases. The topical drug development process is reviewed in the introduction of the thesis. In particular, past …

    greenwich Repository record for Topical pharmacokinetics for a rational and effective topical drug development process (opens in a new tab)

  12. Altering the Regiospecificity of C6 Indole Prenyltransferase Enzymes Towards Drug Development

    … us to utilize PTs as a unique approach towards drug development. PriB PT is an example of aromatic PTs that has been characterized previously as a L-tryptophan (L-Trp) C6 <em>C</em>-prenyltransferase (C6-<em>C</em>-PT). Analysis of PriB binding pocket, highlighted key residues that might play an …

    chapman Repository record for Altering the Regiospecificity of C6 Indole Prenyltransferase Enzymes Towards Drug Development (opens in a new tab)

  13. Portfolio valuation in early drug development : a systematic accounting of utility

    Pharmaceutical drug development is exhibiting a consistent trend of increased R&D investment required per successful therapy brought to market. Simultaneously, cultural and political sentiment is increasingly putting downward pricing pressure on new therapies. In this difficult environment it is …

    mit Repository record for Portfolio valuation in early drug development : a systematic accounting of utility (opens in a new tab)

  14. Amplifying signals in the tumor microenvironment for drug development and diagnostics

    … the pace of biological discovery leading to the development of targeted therapies and immunotherapies, which have resulted in unprecedented survival benefits for patients. Additionally, they have also materialized in how disease is diagnosed and monitored, which increasingly involves genomic …

    mit Repository record for Amplifying signals in the tumor microenvironment for drug development and diagnostics (opens in a new tab)

  15. Assessing the impact of tumor evolution on oncology drug development and commercialization

    … developing and commercializing targeted oncology drugs directed at a specific tumor mutation instead of all forms and mutations of a single target. While oncologic drugs targeted to aberrant or overexpressed pro-proliferative proteins have revolutionized cancer treatment, tumors treated for long …

    mit Repository record for Assessing the impact of tumor evolution on oncology drug development and commercialization (opens in a new tab)

  16. Targeting protein: protein interaction sites for drug development against voltage-gated sodium channels

    … including psychological, neurological and developmental disorders. Unfortunately, currently available drugs targeting Nav channels are directed against highly conserved domains of the α-subunit of all Nav channels, and as such they have severe side effects, including cardiac malfunction. …

    utmb Repository record for Targeting protein: protein interaction sites for drug development against voltage-gated sodium channels (opens in a new tab)

  17. The role of subgroups and sub-populations in drug development and drug regulation

    … the role of subgroups and sub-populations in drug development and regulation and includes the critical appraisal of regulatory guidance.<br></br><br></br>Chapter One introduces clinical trial methodology and describes the current regulatory environment.<br></br><br></br>In Chapter Two, …

    the-open-u Repository record for The role of subgroups and sub-populations in drug development and drug regulation (opens in a new tab)

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