Cytostatic anticancer drug development: preclinical studies and early clinical trials (Frankfurt/Main, November 1989)

1990 ◽  
Vol 116 (2) ◽  
pp. 224-227 ◽  
Author(s):  
Wolfgang E. Berdel ◽  
Heinz -H. Fiebig
Keyword(s):  
Clinical Trials ◽  
Drug Development ◽  
Anticancer Drug ◽  
Preclinical Studies ◽  
Anticancer Drug Development

Clinical Drug Development for the Treatment of Pulmonary Arterial Hypertension: Collaboration With the Pharmaceutical Industry and Regulatory Agencies

2010 ◽  
Vol 9 (4) ◽  
pp. 214-219
Author(s):  
Robyn J. Barst
Keyword(s):  
Clinical Trials ◽  
Pulmonary Arterial Hypertension ◽  
Drug Development ◽  
Phase 1 ◽  
Preclinical Studies ◽  
Phase 2 ◽  
Phase 3 ◽  
Preclinical Testing ◽  
New Drug ◽  
Pulmonary Arterial

Drug development is the entire process of introducing a new drug to the market. It involves drug discovery, screening, preclinical testing, an Investigational New Drug (IND) application in the US or a Clinical Trial Application (CTA) in the EU, phase 1–3 clinical trials, a New Drug Application (NDA), Food and Drug Administration (FDA) review and approval, and postapproval studies required for continuing safety evaluation. Preclinical testing assesses safety and biologic activity, phase 1 determines safety and dosage, phase 2 evaluates efficacy and side effects, and phase 3 confirms efficacy and monitors adverse effects in a larger number of patients. Postapproval studies provide additional postmarketing data. On average, it takes 15 years from preclinical studies to regulatory approval by the FDA: about 3.5–6.5 years for preclinical, 1–1.5 years for phase 1, 2 years for phase 2, 3–3.5 years for phase 3, and 1.5–2.5 years for filing the NDA and completing the FDA review process. Of approximately 5000 compounds evaluated in preclinical studies, about 5 compounds enter clinical trials, and 1 compound is approved (Tufts Center for the Study of Drug Development, 2011). Most drug development programs include approximately 35–40 phase 1 studies, 15 phase 2 studies, and 3–5 pivotal trials with more than 5000 patients enrolled. Thus, to produce safe and effective drugs in a regulated environment is a highly complex process. Against this backdrop, what is the best way to develop drugs for pulmonary arterial hypertension (PAH), an orphan disease often rapidly fatal within several years of diagnosis and in which spontaneous regression does not occur?

Applications of liquid biopsy in the Pharmacological Audit Trail for anticancer drug development

2021 ◽  
Author(s):  
Abhijit Pal ◽  
Rajiv Shinde ◽  
Manuel Selvi Miralles ◽  
Paul Workman ◽  
Johann de Bono
Keyword(s):  
Drug Development ◽  
Anticancer Drug ◽  
Liquid Biopsy ◽  
Audit Trail ◽  
Anticancer Drug Development

Non-invasive MRS in new anticancer drug development

1992 ◽  
Vol 5 (5) ◽  
pp. 270-272 ◽  
Author(s):  
Paul Workman ◽  
Ross J. Maxwell ◽  
John R. Griffiths
Keyword(s):  
Drug Development ◽  
Anticancer Drug ◽  
Non Invasive ◽  
Anticancer Drug Development
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