Dimethoxybenzylidene which is abbreviated as DMXB-A is a drug is administered orally. It helps improve neuropsychological and attention in schizophrenia, hence an improved psychological outcome. There were three teams which were in the production of the drug and they were exploratory development team, project development team, clinical development and brand development team. They were tasked with discovery research, exploratory and full development, filling, launching and growth and maintenance.
The major team was the clinical development team whose main roles were developing a clinical development plan, manage its execution and compiling the clinical portion of the regulatory submission in form of a case report form (CRF). There are two models under study design. These are traditional model and Innovative/adaptive model. Traditional model is further divided into phase 1,2,and3. Phase 1, the drug safety and tolerability must be established. One has to start with no-effect dose then later on take maximally tolerated dose. The dose range of cover 3-5 fold difference. During the initial stages single dose is recommended but between 5-7 days, multiple dose is advised. Under phase 2 is further subdivided into phase 2a and phase 2b, the sample size is usually above 50 patients depending on the state of the disease. Its duration is between 1-5 year and studies conducted on patients and volunteers.
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Phase 2a which also known as pilot studies. Its initial step also is to determine the safety, efficacy and tolerability in patients, tolerated dose range in patients is also established. Thereafter evaluation is done on relevant biomarkers and pharmacokinetic parameters in patients. Estimation of degree of variation is also essential. Proof of concept states that the drug must demonstrate right pharmacology, appropriate therapeutic index and reach intended target and intended tissues. It should also be enriched with collection of data such as plasma and genomic (Meyer et al.).
Adaptive trial uses accumulating data from ongoing study. Its advantage is that it increases the likelihood of selecting phase 3 dose and it use more ethical treatment considerations. The early phase of adaptive trial is to find safe and effective dose while the later phase makes prospective changes to future trials. The traditional plan of adaptive design takes a duration of 16-22 week whereby SAD (4-5 dose) and MAD (3-4 dose) are administered. While modified adaptive design takes a duration of 12-18 weeks. Phase 2b one determines the dose range and level of phase 3 while confirming the its primary endpoints and estimating treatment effects. Phase 3 includes pivotal trials which generate clinically and statistically significant evidence. It involves thousands of patients and takes a span of 3.5 years. It was noted that between 2011 and 2015 that on a single pivotal, 50 % of new drug approvals were made (Sagineedu et al.).
Treatment groups were Experimental Therapy groups and control groups. Pompe disease showed that 70-80 % of children die as a result of cardiac failure before they attain the age of 1 year. In a case study carried out, it was found that in the treatment of Parkison’s disease by use of antidepressants, 65 % of the patients improved through active drug treatment. In the double-blind study, the percentage of the patients who improved were only 20%. In an early study carried out, it showed that recombinant GAA helped improve cardiac, survival and respiratory functions. It was concluded that patients who received rhGAA had 90% survival chances and were free from ventilation
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