Biopharmaceutics Applications of Physiologically Based Pharmacokinetic Absorption Modeling and Simulation in Regulatory Submissions to the U.S. Food and Drug Administration for New Drugs

2021 ◽  
Vol 23 (2) ◽  
Author(s):  
Fang Wu ◽  
Heta Shah ◽  
Min Li ◽  
Peng Duan ◽  
Ping Zhao ◽  
...  
Keyword(s):  
Modeling And Simulation ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
New Drugs ◽  
Physiologically Based Pharmacokinetic ◽  
Physiologically Based ◽  
Regulatory Submissions ◽  
Absorption Modeling ◽  
The U.S

scholarly journals The emperor's new drugs: An analysis of antidepressant medication data submitted to the U.S. Food and Drug Administration.

2002 ◽  
Vol 5 (No Issue Specified) ◽  
pp. No First Page Specified-No Last Page Specified ◽  
Author(s):  
Irving Kirsch ◽  
Thomas J. Moore ◽  
Alan Scoboria ◽  
Sarah S. Nicholls
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Antidepressant Medication ◽  
New Drugs ◽  
The U.S

Project Zero Delay: A Process for Accelerating the Activation of Cancer Clinical Trials

2009 ◽  
Vol 27 (26) ◽  
pp. 4433-4440 ◽  
Author(s):  
Razelle Kurzrock ◽  
Susan Pilat ◽  
Marcel Bartolazzi ◽  
Dwana Sanders ◽  
Jill Van Wart Hood ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Phase I ◽  
Drug Administration ◽  
Strategic Alliance ◽  
Food And Drug Administration ◽  
Good Practice ◽  
New Drugs ◽  
Cancer Center ◽  
Institutional Review ◽  
Regulatory Submissions

Drug development in cancer research is lengthy and expensive. One of the rate-limiting steps is the initiation of first-in-human (phase I) trials. Three to 6 months can elapse between investigational new drug (IND) approval by the US Food and Drug Administration and the entry of a first patient. Issues related to patient participation have been well analyzed, but the administrative processes relevant to implementing clinical trials have received less attention. While industry and academia often partner for the performance of phase I studies, their administrative processes are generally performed independently, and their timelines driven by different priorities: safety reviews, clinical operations, regulatory submissions, and contracting of clinical delivery vendors for industry; contracts, budgets, and institutional review board approval for academia. Both processes converge on US Food and Drug Administration approval of an IND. In the context of a strategic alliance between M. D. Anderson Cancer Center and AstraZeneca Pharmaceuticals LP, a concerted effort has been made to eliminate delays in implementing clinical trials. These efforts focused on close communications, identifying and matching key timelines, alignment of priorities, and tackling administrative processes in parallel, rather than sequentially. In a recent, first-in-human trial, the study was activated and the first patient identified in 46 days from completion of the final study protocol and about 48 hours after final US Food and Drug Administration IND approval, reducing the overall timeline by about 3 months, while meeting all clinical good practice guidelines. Eliminating administrative delays can accelerate the evaluation of new drugs without compromising patient safety or the quality of clinical research.

The Drug Regulatory System of the United States Food and Drug Administration: A Defense of Current Requirements for Safety and Efficacy

1974 ◽  
Vol 4 (1) ◽  
pp. 95-107 ◽  
Author(s):  
Henry E. Simmons
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Regulatory System ◽  
The United States ◽  
New Drugs ◽  
Safety And Efficacy ◽  
Regulatory Policies ◽  
New Drug ◽  
United States Food ◽  
The U.S

The 1962 Amendments to the Food, Drug, and Cosmetic Act have substantially increased the accountability of manufacturers of new drugs, both by raising standards for clinical testing as well as requiring, for the first time, a demonstration of proof of efficacy. Critics of the new regulatory system of the Food and Drug Administration (FDA) which imposes the requirements, have called for the repeal of the new standards on the grounds that they are stringent to the point of being counterproductive, reflect an unwarranted and excessive concern over drug safety, and have jeopardized the position of the U.S. in the worldwide development of new drugs. The author defends the regulatory system against these criticisms by demonstrating the importance of the scientific standards it has deemed essential for evaluating and approving new drug applications. Evidence of tragedy caused by inefficacious and unsafe drugs used in other countries but not in the U.S. supports FDA concern over safety and efficacy, and indicates that through its caution, the U.S. has doubtlessly been spared similar tragedy. Finally, worldwide trends in new drug development are investigated and it is shown that many factors are involved in the variation in the number and variety of drugs introduced in the marketplace of any given country which have nothing to do with its regulatory policies. It is concluded that FDA's regulatory system serves to assure the safety and efficacy of all drugs introduced into this country, while at the same time, continues to support and encourage the development of significant new drugs.

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