Radioimmunoassay（RIA）
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RIA is probably the oldest type of immunoassay. The radioactive isotope is used to label the antibody/antigen. The amount of radioactive signals is inversely proportional to that of target antigens.https://www.creative-biolabs.com/immuno-oncology/immunoassay.htm
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✔ Assembling and binding volumes
✔ Submission
https://www.creative-biolabs.com/immuno-oncology/ind-publishing-and-submission.htm
Pre-IND Meeting
For the drug development, pre-IND meeting is a critical tool to discuss the needs and challenges specific to the general product development, nonclinical testing, manufacturing information, protocol design or other regulatory questions defined in the Code of Federal Regulations (21 CFR 312.82). https://www.creative-biolabs.com/immuno-oncology/pre-ind-meeting.htm
Medical Writing and Translation
✔ Clinical overviews (eCTD Module 2.5) including literature review and references
✔ Clinical summaries (eCTD Module 2.7) including clinical pharmacology, efficacy, and safety
✔ Clinical study report preparation and review (eCTD Module 5)
✔ Clinical justification documents for EU, US and other emerging Regulatory markets
✔ Gap analysis for dossiers in clinical module
✔ Clinical and nonclinical document support, handling queries during HA meetings and responding to them
✔ Technical review dossiers
✔ Biowaiver support and justification document services
https://www.creative-biolabs.com/immuno-oncology/medical-writing-and-translation.htm
Regulatory Strategy Consulting
To gain approval for clinical testing after finalizing the pre-clinical testing of innovative new therapies, it is a key milestone for pharmaceutical companies to apply for approval of Investigational New Drug (IND) with FDA or other agencies.https://www.creative-biolabs.com/immuno-oncology/regulatory-strategy-consulting.htm
IND Regulatory Services
Navigating the drug development process from early stage discovery to clinical stage is complex and expensive. https://www.creative-biolabs.com/immuno-oncology/ind-regulatory-services.htm
cGMP Manufacturing
In the United States, the Current Good Manufacturing Practice (cGMP) is the Food and Drug Administration (FDA) 's formal regulations on the design, monitoring, control and maintenance of manufacturing processes and facilities.https://www.creative-biolabs.com/immuno-oncology/cgmp-manufacturing.htm
Antibody and Protein Toxicology
Pre-clinical toxicology is a study of the toxic effects of drugs in development based on statistical and quantitative analysis. https://www.creative-biolabs.com/immuno-oncology/antibody-and-protein-toxicology.htm
Antibody and Protein Pharmacology
Pharmacology is a key component concerned with the study of drug action in animal models which is essential and determinant to IND approval and ultimate NDA approval for a drug candidate. https://www.creative-biolabs.com/immuno-oncology/antibody-and-protein-pharmacology.htm
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