Ajulemic Acid (IP-751): Synthesis, Proof of Principle, Toxicity Studies, and Clinical Trials

1 The potential for toxicity to reproduction and the developing fetus is an important concern requiring attention during the development of new medicines. However, there are differences in the opinions of the regulatory authorities in Europe, Japan and the USA regarding the nature and amount of data from reproductive toxicity tests that should be available at the various stages of clinical development. 2 Forty-one companies or their subsidiaries from Eur ope, Japan and the USA provided data for a ques tionnaire-based study, carried out in 1994, to ascertain the practices of pharmaceutical companies and their views on an ideal approach to the timing of reproduc tion and development toxicity studies in relation to clinical investigation. 3 Differences were identified in the stage of drug development at which animal studies were completed, the sequence of completion of specific studies, and the extent of reproduction testing completed to support the inclusion of women in clinical trials. 4 A harmonised, but flexible, guideline, encompassing the timing of reproductive toxicity studies in relation to clinical trials, would permit better integration between clinical and non-clinical studies in an international drug development programme.

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The pharmaceutical industry's experience concerning animal toxicity studies predicting adverse effects in clinical trials — the ILSI/HESI report

Toxicology Letters ◽

10.1016/s0378-4274(98)80102-1 ◽

1998 ◽

Vol 95 ◽

pp. 26

Author(s):

H.M. Olson

Keyword(s):

Clinical Trials ◽

Adverse Effects ◽

Toxicity Studies ◽

Animal Toxicity

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Innovative Therapies in Wound Healing

Journal of Cutaneous Medicine and Surgery ◽

10.1177/120347540300700305 ◽

2003 ◽

Vol 7 (3) ◽

pp. 217-224 ◽

Cited By ~ 6

Author(s):

John T. Shen ◽

Vincent Falanga

Keyword(s):

Wound Healing ◽

Clinical Trials ◽

Growth Factors ◽

Delivery System ◽

Diabetic Ulcers ◽

Venous Ulcers ◽

Novel Treatment ◽

Innovative Therapies ◽

Bioengineered Skin ◽

Proof Of Principle

Background: Apligraf is a bioengineered skin product composed of neonatal fibroblasts and keratinocytes. The FDA has approved Apligraf for the treatment of chronic venous ulcers and diabetic ulcers. Objective: We review the development of bioengineered skin, examine the cellular activities of various growth factors that may facilitate wound healing, and discuss the results of clinical trials with a particular construct, Apligraf, as proof of principle. Conclusion: Bioengineered skin acts as a “smart” delivery system for growth factors and other stimulatory substances. Not only does it present a novel treatment for chronic and diabetic ulcers, but it could also be considered for application to other types of acute wounds.

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Update on the War on Mental Illness

Convergence Mental Health ◽

10.1093/med/9780197506271.003.0009 ◽

2021 ◽

pp. 103-122

Author(s):

Seth W Perry ◽

Ma-Li Wong ◽

Julio Licinio

Keyword(s):

Mental Health ◽

Mental Illness ◽

Clinical Trials ◽

Global Health ◽

Mental Health Disorders ◽

Translational Science ◽

Call To Action ◽

Health Disorders ◽

Proof Of Principle

The authors first called for a “war on mental illness” in 2013. In this update, they re-establish and expand the previous concepts and arguments for translational psychiatry’s role in combating mental health disorders worldwide. The authors discuss the six steps of translational science (discovery, first in humans or proof of principle, clinical trials, healthcare policy and guidelines, long-term effectiveness and safety, and global health). Further, they highlight progress made since their initial call to action and renew and update their call with increased attention to how the principles of transdisciplinary and convergence science can be harnessed for expediting and maximizing progress toward new and improved therapies for mental illness.

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