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Najib Babul Discusses the Benefits and Limitations of the 505(B)(2) Regulatory Pathway For Drug Approval

Najib Babul Discusses the Benefits and Limitations of the 505(B)(2) Regulatory Pathway For Drug Approval
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Najib Babul Discusses Erythropoietic Protoporphyria for a Severe Photodermatosis

Press release content from Accesswire. The AP news staff was not involved in its creation. Najib Babul Discusses Erythropoietic Protoporphyria for a Severe Photodermatosis January 8, 2021 GMT CLARK COUNTY, NV / ACCESSWIRE / January 7, 2021 / Erythropoietic protoporphyria (EPP) is a devastating lifelong disorder characterized by dermal photosensitivity with only one recently approved treatment and very few evidence-based clinical management tools. Dr. Najib Babul, an experienced drug development and regulatory affairs consultant discusses this serious debilitating condition. EPP is a rare inherited disorder of heme biosynthesis characterized by dermal photosensitivity secondary to a partial deficiency of ferrochelatase. In a phenotypically similar X-linked protoporphyria (XLP), there is overactivity of the heme biosynthesis enzyme, erythropoietic aminolevulinate synthase (ALAS2). Both EPP and XLP result in the accumulation of the photosensitizer protoporphyrin IX (PPIX) in erythro

Cinergen: Najib Babul Discusses Erythropoietic Protoporphyria for a Severe Photodermatosis

Cinergen: Najib Babul Discusses Erythropoietic Protoporphyria for a Severe Photodermatosis CLARK COUNTY, NV / ACCESSWIRE / January 7, 2021 / Erythropoietic protoporphyria (EPP) is a devastating lifelong disorder characterized by dermal photosensitivity with only one recently approved treatment and very few evidence-based clinical management tools. Dr. Najib Babul, an experienced drug development and regulatory affairs consultant discusses this serious debilitating condition. EPP is a rare inherited disorder of heme biosynthesis characterized by dermal photosensitivity secondary to a partial deficiency of ferrochelatase. In a phenotypically similar X-linked protoporphyria (XLP), there is overactivity of the heme biosynthesis enzyme, erythropoietic aminolevulinate synthase (ALAS2). Both EPP and XLP result in the accumulation of the photosensitizer protoporphyrin IX (PPIX) in erythrocytes, plasma, skin and liver. The accumulated PPIX is activated by sun exposure, thus generating free

Cinergen: Najib Babul: On the Accuracy of Acute Pain Recall

Cinergen: Najib Babul: On the Accuracy of Acute Pain Recall CLARK COUNTY, NV / ACCESSWIRE / January 5, 2021 / The accuracy of pain recall has important implications for both clinical trials and clinical management where pain is a prominent or primary outcome measure or symptom. Dr. Najib Babul, an experienced drug development and regulatory affairs consultant discusses the accuracy of remembered pain and the benefits and limitations of relying on patient s memory for pain. His conclusion, as reported in peer-reviewed medical journals is that patient recollection of acute pain is generally quite reliable. Pain is a major public health problem, resulting in personal suffering, reduced productivity, and increased health care costs. A report from the Institute of Medicine Committee on Advancing Pain Research, Care, and Education states that chronic pain affects approximately 100 million adults in the U.S. and costs the economy over $600 billion annually. This includes $300 billion in d

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