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MPI Research Inc
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“The addition of a truly elite talent such as Dr. Vidal to our team creates important new opportunities for MPI Research and our Sponsors,” said Dr. Daniel Patrick, Director of Pathology. “His specialization in reproductive studies encompasses a growing area of concern and interest for pharmaceutical and chemical developers worldwide.” #pathology   #MPIResearch  

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Biofilms may explain many of the challenges clinicians face with wound care, infection and healing. Due to antibiotic resistance, biofilms may cause chronic infections or prevent wounds from fully healing because an infection is never fully eradicated. Persistent infection can lead to systemic infections, risky prolonged exposure to antibiotics or amputation of the infected site. #biofilm   #infection   #healing  

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Antibody drug conjugates (ADCs) are a newer class of chemotherapeutics comprised of monoclonal antibodies that selectively bind to tumor-associated antigens and have an associated cytotoxic small-molecule payload.

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Potency is a required measurement to determine the amount of active ingredient contained in a preclinical dose formulation. Assessing potency ensures that the test system receives the appropriate amount of active ingredient based on predetermined specifications. Potency determinations are made using a validated analytical method. We have identified some factors for consideration in order to have the most effective sample preparation that result in accurate potency measures.

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We recently participated in the October Standard for Exchange of Nonclinical Data (SEND) Face-to-Face meeting between the FDA and industry. We want to share with you our take-a-ways on the latest SEND developments from this productive session. The FDA is encouraging the industry to submit sample SEND datasets for technical review and the FDA described the process for submitting sample datasets. It is important to closely follow the process described on the FDA website to avoid potential delays in the review process. #FDA   #SEND  

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The answer is yes! Establishing adequate stability of a preclinical dose formulation is a critical component in drug development, as it ensures that the test system receives the appropriate amount of test article based on protocol specifications. Considerations for designing adequate stability protocols must include assessment of formulation, storage, and dosing conditions. #preclinical   #doseformulation   #stability  

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When transitioning from lead optimization to development, there are several factors that should be understood prior to conducting GLP toxicity studies. These include performing a gap analysis which involves identifying the bioanalytical method ranges and selecting appropriate collection intervals to accurately quantify systemic exposure. #pharmacokinetic   #pkstudies   #Bioanalytical  

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At MPI Research, we always recommend conducting “A Gap Analysis” to identify deficiencies and provide an approach moving forward that mitigates risk and accounts for unknown factors that may require consideration. #gapanalysis   #pharmacokinetic  

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In today’s world of drug development, almost every aspect of the development continuum is related to speed, efficiency, precision, and quality. Whether it is a generic company racing to first-to-file status, a virtual or biotech company looking to entice Sponsors with promising data, or a mid-large pharma organization seeking its next promising candidate for New Drug Application (NDA) filing and approval – every aspect of the development process needs to progress seamlessly. #drugdevelopment  

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MPI Research is proud to be part of helping save lives by providing a model for testing the efficacy of platelet replacement products.
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