A non-profit organization of stakeholders with interest in improving drug development productivity. We are particularly interested in your experience with the challenges of drug development whether as member of industry, academia, regulatory, CROs, non-profit organizations, as a patient or a member of the public at large. If you are interested in being part of the Network and contributing to Network discussions and activities please read the description below and send us the registration information. We welcome sponsors and donors who would like to support our activities.
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Phase-0/Microdosing Network description (Phase-0Microdosing.org):
The Phase-0/Microdosing Network, a non-profit organization, is an international consortium of cross-disciplinary stakeholders with interest in improving the productivity of drug development. The organization's main goal is to help determine the role and potential applications of Phase-0 including microdosing approaches in drug development. Other objectives include disseminating information and supporting research relevant to these approaches. Members include clinicians, scientists, regulators, Pharma, Biotech, CROs, patient advocacy groups and other non-profit organizations with interest in the potential of these approaches to accelerate drug development by providing safer, earlier, faster, and cheaper, in-vivo human data for developmental decision-making.
The Network aims to use the collective cross-disciplinary knowledge and skills of its members to maximize the potential of these approaches to provide cost-effective solutions to developmental challenges. There is considerable translational potential in the range of analytical tools such as AMS, PET, LC-MS/MS, the continuum of microdosing and other Phase-0 methodologies, and their permutations. The complementary and synergistic potential of these investigational tools should be considered as early as possible in the drug development process to optimize their potential impact. The network welcomes and encourages discussion of the limitations of these approaches.
Rules of Engagement
Members are welcome to introduce their operations, strategic philosophies, and studies, as they may be relevant to the future of this field while avoiding discussion of purely commercial entities and services.
Members can share information that is scientific in nature directly to the membership on the Network. If the information is administrative, logistic, operational or other non-scientific site- or organization-specific information that the member has personal interest in, it should be first shared with Network administration to decide if and how to communicate it. As an example, the use of AMS, LC/MS-MS, or PET in a particular drug development scenario, though technical and operational in nature, is scientific in the sense that it discusses a general 'truth' about the use these tools rather than being local, circumstantial, logistical or commercial information. But if the information is on the capabilities of a particular operational site then it should be shared with Network administration to decide whether it is of interest to the group at large.
Only material that is in the public domain (e.g., peer-reviewed articles), or otherwise owned by Network members, can be shared over the Network.
Quarterly teleconferences and meetings on the occasion of major conferences will take place as appropriate. There will be no sharing of contact information or other personal data with third parties.
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|Dose to be Administered||Start and Maximum Doses|
|Total cumulative dose < 500 pg, maximum of 5 administrations with a washout between doses (6 or more actual or predicted half-lives)
each dose < 100 pg
each dose < 1/100th of the NOAEL and < 1/100th of the pharmacologically active dose.
|Maximal daily and starting doses can be the same, but not exceed 100 pg.|
|Pharmacology||General Toxicity Studies a||Genotoxicity b / Other|
|In vitro target/receptor profiling should be conducted.
Appropriate characterization of primary pharmacology (mode of action and/or effects) in a pharmacodynamically relevant model should be available to support human dose selection.
|7-day repeated-dose toxicity study in one species, usually rodent, by intended route of administration with toxicokinetic data, or via the i.v. route. Hematology, clinical chemistry, necropsy, and histopathology data should be included. A maximum dose of 1000-fold the clinical dose on a mg/kg basis for i.v. and mg/m2 for oral administration can be used.||Genotoxicity studies are not recommended, but any studies or SAR assessments conducted should be included in the clinical trial application.
For highly radioactive agents (e.g., PET imaging agents), appropriate PK and dosimetry estimates should be submitted.