Rituximab: A Case Study

2015). So many strategical methods can be applied to achieve a safety use of the off label medications, such as collaboration of the regulatory agencies, the provider/prescribers and the pharmaceutical companies in determining a common and safe guideline. Also, using the patient’s height and weight to calculate appropriate dosage needed. In addition, a small starting dose should be prescribed and increased dosage gradually as tolerated as long as the liver and kidney functions are within normal range. Finally, parents should be instructed to stop the medication and report to the health care provider once an adverse reactions are

Implementation of Good Clinical Practices under part 21 CFR 50 (protection of human subjects) which includes the document ICFs, under part 21 CFR 54 (Financial Disclosure), under part 21 CFR 56 (IRBs) and Under part 21 CFR 312 (Investigational New Drug Application) should be provided. [7] These documents will help us to ensure whether the study was performed with the willingness of subjects ' to participate and the subjects were aware of the risks and benefits to the exposure to the drug. And also the sponsor and investigator both had signed the financial disclosure forms.

The healthcare rofessional explain the process of obtaining the investigational product to the patient is of prime importance especially when the patient has exhausted all the available medications and therapies. During the clinical trials, Andrea or any patient cannot obtain the drug until the drug becomes approved or the patient is eligible for the study according to the protocol. Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement. The investigational new drug (IND) is the means through which the sponsor technically obtains this exemption from the FDA. The IND is not an application for marketing approval. Rather, it is a

Patients are selected randomized to receive Rituximab 400 mg intravenous (IV) every 3 weeks up to1 year. Patients are randomized to the standard of care for chemotherapy will get treatment as per the Physician’s choice and suggested dosage. All patients will be called for the follow up for up to 2 years after last dose of drug or until the death. The overall response rate (ORR), overall survival (OS), progression-free survival (PFS), and clinical advantage will be observed.

Good understanding of FDA submission (IND, NDA), clinical protocols, CRFs, CDISC, ICH guidelines, 21 CFR Part 11, GCP guidelines, and IRB guidelines.

United States. FDA. 21 U.S. Code § 321 (g). N.p., n.d. Web. 20 June 2015.

In this paper, I am going to discuss about the premarket approval process for pharmaceuticals from its drug development to ultimate approval conducted in Canada and United States. The main intention of Canada (Health Canada) and United States(USFDA) is safety and well-being of public.

The KEYNOTE-024 trial was designed by Merck representatives and academic advisors. According to European legislation, Merck, as the Sponsor, designated, per country, a national principal coordinator, responsible for coordinating the work of the principal investigators at the different trial sites in each member state of the multicentre trial, according to national regulations. Each coordinator agreed to allow: 1) the respect of local laws, rules and regulations relating to the conduct of the clinical trial; 2) a regulatory authority inspection of trial-related documents and procedures and 3) the access to all trial-related source data and documents. The Code of Conduct, a collection of goals and considerations that govern the ethical and scientific

The next step is we should Set up and implement the SOP. Prior to submission of the protocol to the IRB and/or to an external funding agency, the investigator should meet with the clinical research pharmacist or designee to review the feasibility of the proposed protocol. (prep course#14 advanced good clinical practice)The study protocol, as well as all requirements for study drug preparation should be reviewed. Because the consent and assent documents are highly dependent on the content of the protocol, their development will begin as soon as the protocol procedures and study-associated risks are well described. A quality assurance unit does the systematic and independent examination of all trial-related activities and documents which determines whether the evaluated activities were appropriately conducted and that the data were generated, recorded, analyzed, and accurately reported according to protocol, standard operating procedures and good clinical practices. (Advanced good clinical practice). A safety oversight review is to be conducted to independently assess the safety data (e.g., adverse events and unanticipated problems) as well as study progress (e.g., recruitment and enrollment), study conduct (e.g., protocol deviations), and key data elements determined on an individual study basis. (national institute of dental and craniofacial

Patients randomized to Rituximab will receive 400 mg intravenously (IV) every 3 weeks up to 12 months. Patients randomized to standard of care for chemotherapy will receive treatment per the Physician’s choice and recommended dosage. All patients will be followed for up to 24 months after last dose of study medications or until death. Overall response rate (ORR), progression-free survival (PFS), overall survival (OS) and clinical benefit will be determined.

The mAbs bind to antigen on the cell surface and exposes their binding sites for proteins. These proteins initiate the complement cascade and trigger the release of chemotactic factors and the formation of the membrane attack complex, which promotes target-cell lysis. Rituximab shows this activity.

According to the ICH-GCP guidelines, clinical trial monitoring is required to oversee the clinical trial, to ensure that the trial is conducted, recorded, and reported according to the protocol, the guidelines of good clinical practice, the SOPs, and the applicable regulatory requirements. Monitoring is an ongoing process conducted before, during and after clinical trials, and is classified into four distinct types of visits (pre-initiation, initiation, routine and close out visits). Monitoring is also a quality control measure that helps to ensure the integrity of clinical data and to protect the rights and well-being of the study participants.

On 28 June 2004, Biogen Idec and Elan Corporation, plc declared that the Biologics License Application for natalizumab had been entitled for Priority Review and Accelerated Approval by the U.S. Food and Drug Administration for the treatment of multiple sclerosis. The next step in the process was action by the FDA on formal acceptance of the application, which occurs within 60 days of submission. The FDA grants Priority Review status to products that are considered to be potentially meaningful therapeutic progressions over existing therapies that address an unmet medical need. Based on the FDA's designation of Priority Review for natalizumab in MS, the companies predicted action by the Agency approximately six months from the submission date,

The pharmaceutical industry proficiency involved secondary research on oncology drug development, disease states, therapeutic area strategies and new treatment modalities. The proficiency in clinical trial methodologies, design and statistics enables to interpret and coordinate the clinical research and human biological specimens’ activities, documentation and support functions. The familiarity with clinical trial procedures, guidelines and regulations also ensures a high level of compliance, accuracy and integrity of study data by tracking and reviewing documentation for subject management, study-related findings and post-clinic action plans.

Pre-Clinical trial is a series of experiment carried out on animals to test the feasibility, toxicity and safety of the drugs prior to human usage. This means that through the analysis of the animals’ responses to the drugs, data are collected. After sufficient data are collected clinical trials can then be carried out on human. Pre-clinical trials are required as it might be unethical and inhuman to carry out clinical trials on humans without knowing the side effects of the drugs. Some of the side effects might cause serious injuries, paralysis or even death to the consumers if pre-clinical trials are not carried out.