Development of prednisone for Severe Arthritis Treatment

Development of prednison for Severe Arthritis Treatment
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Question 1
Discuss the Preclinical Research and Approvals (regulatory and other) that are required prior to commencing human Clinical Trials. What are the Safety and other requirements that need to be satisfied?
Preclinical research is a kind of study performed before actual clinical trials in human beings. This includes the collection of drug safety data, iterative testing and feasibility. In clinical trials, preclinical research is a crucial element in the determination of the future safety of the product. In clinical studies involving humans, researchers are expected to adhere to good clinical practices (GCP). Protection of human subjects is part of this good clinical practice. These researchers are also required to prepare documents for obtaining informed consent on these subjects. They are also expected to obtain an approval from an institutional review board before commencing such studies. In addition to these is that the researchers are required to prepare a clinical protocol, which they will employ in the study. The protocol is a description of the objectives, rationale, methodology, and design of the study. This is then presented to the investigators and a panel of experts for review.
Question 2
Having satisfied these preclinical Requirements, you are ready to proceed to Phase 1 “first into man studies.” Discuss the key requirement for the phase I study design. Discuss also the key aspects of phase 1 study including data collection, data analysis, and reporting requirements
This phase involves the collection of data pertaining to the safety of the drug and the participants involved in the study. Data collection will also entail the physiological responses of humans with regard to the provision of the sub therapeutic doses. The trials will be conducted in the clinical trial clinic, where the participants will be observed by staff on full time basis. Twenty health volunteers will be used in the study.
The study design for this trial is described as
Purpose: Treatment
Allocation: Non- randomized
Classification of endpoint: Pharmacokinetics research
Masking: Open Lable
In the case when the sub therapeutic doses offered do not indicate any side effects to these patients, and the pharmacokinetic data is aligned with safe values, the sub therapeutic dose should then be escalated and given to another group of people at high dose. If the level of toxicity is observed after this administration in any subject, an additional three subjects will be treated simultaneously for a similar dose. This will go on up to the time when the pre-calculated pharmacokinetic safety levels are observed, or when the side effects that appear to be intolerable shows up. At this point, the drug would have reached its limit in the tolerated dose. In the observation of unacceptable level of toxicity, ...