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Data Integrity and Compliance With CGMP

Pharma Tutor

Data Integrity and Compliance With CGMP. Read more about Data Integrity and Compliance With CGMP Log in or register to post comments Read more about Data Integrity and Compliance With CGMP Log in or register to post comments Data integrity refers to the completeness, consistency, and accuracy of data. Sat, 07/09/2022 - 16:51.

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EVALUATION OF PROCESSED FOOD ACCEPTANCE AND ITS REGULATORY COMPLIANCE IN ASIAN COUNTRIES

Pharma Tutor

EVALUATION OF PROCESSED FOOD ACCEPTANCE AND ITS REGULATORY COMPLIANCE IN ASIAN COUNTRIES. Mon, 11/14/2022 - 17:09. Avdesh Thassu. MPharm (Nat. Associate Vice President. Global Regulatory Affairs, Emami Limited athassu@hotmail.com. Articles.

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Versanis’ bimagrumab, first-in-class obesity therapy, enters Phase IIb of development

Pharmaceutical Technology

While tirzepatide requires weekly administration, bimagrumab is administered once every four weeks, which should have positive implications on patient compliance. Despite its high price tag, bimagrumab’s unique features set it apart from currently marketed therapies.

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AI-Powered Precision Engagement in Commercial and Medical Functions

Intouch Solutions

Instead, it will be a transformational process that affects various functions of the organization, triggering considerations related to data privacy and security, regulatory compliance, and change management. Facilitating cost containment and expediting the content approval process in accordance with regulatory compliance.

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Grand Rounds May 19, 2023: Aspirin or Low-Molecular-Weight Heparin for Thromboprophylaxis After a Fracture (Robert O’Toole, MD)

Rethinking Clinical Trials

A pilot study, called the ADAPT trial, demonstrated feasibility, similar in-patient compliance and similar post-discharge adherence for the 2 options. Researchers aimed to test the safety and effectiveness of Aspirin use as prophylaxis in orthopedic trauma cases.

Trials 130
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Grand Rounds December 2, 2022: A Randomized Controlled Trial of Mobile Health Intervention in Heart Failure and Diabetes: Lessons Learned (G. Michael Felker, MD, MHS)

Rethinking Clinical Trials

Adherence to medical therapy was not measurably different between the arms. This trial turned out to be more challenging than anticipated. It was a labor of love; the site payment was low; we asked friends to be sites in the trial. Sites have a lot of trials that are competing. One pays more than another. pctGR, @Collaboratory1.

Trials 130
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What challenges does the advanced therapies sector face? 

Drug Discovery World

Other Challenges: Limited insurance coverage: Many insurance companies are hesitant to cover CGTs due to their high price tags and limited long-term data. Fostering open innovation and collaboration could help address this issue. Increased clinical data and evidence of cost-effectiveness can improve coverage.