
Islah AhmedIntercept Pharmaceuticals, Inc. · Medical Safety and PV
Islah Ahmed
Doctor of Medicine
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Publications (7)
Background:
Biosimilars are defined as biologic products that are highly similar to reference products, notwithstanding minor differences in clinically inactive components, with no clinically meaningful differences between the biologic product and the reference product in terms of safety profile, purity, and potency. Due to the high cost of innova...
Biologics are essential to oncology care. As patents for older biologics begin to expire, the United States is developing an abbreviated regulatory process for the approval of similar biologics (biosimilars), which raises important considerations for the safe and appropriate incorporation of biosimilars into clinical practice for patients with canc...
epoetin zeta is a recently introduced recombinant erythropoietin, designed to be biologically similar to epoetin alfa. This posthoc analysis evaluated the impact of switching patients with chronic kidney disease (CKD) on hemodialysis from epoetin alfa to epoetin zeta, or vice versa, on hemoglobin concentration, epoetin dose, and patient safety.
dat...
In 1994, a standardized dry extract of Ginkgo biloba leaves (SeGb), has been approved by German health authorities for the treatment of primary degenerative dementia and vascular dementia. More than 24 different brands of Ginkgo biloba extract are sold in the United States. Tacrine, also known as tetrahydroaminoacrine (THA), and donepezil are curre...
The pharmacological effects of sulpiride on the central nervous system (CNS) were studied after using brain bioelectricaI activity measurements. Sulpiride is an unusual psychotropic with both antipsychotic and antidepressant properties. In a double-blind, placebo-controlled crossover, quantitative pharmaco-EEG (QPEEG) research design, 100 mg, 200 m...
The central nervous system (CNS) effects of buspirone were evaluated in two separate double-blind, cross-over, placebo-controlled, quantitative pharmaco-EEG (QPEEG) studies. Single doses were used in healthy volunteers, and both single and multiple doses were evaluated in patients with generalized anxiety disorders (GAD). In healthy volunteers, sta...