Why Bioavailability (BA) and bioequivalence (BE) studies are an integral component
Bioavailability (BA) and bioequivalence (BE) studies are an integral component of drug development. They involve comparing two pharmaceutical dosage forms (test and reference) in a randomized clinical trial involving healthy volunteers to assess bioavailability (BA) or bioequivalence (BE).
BE trials typically focus on adult populations; however, their findings can also be applied directly to pediatric patients.
Regulatory Requirements
The FDA requires bioavailability (BA) and bioequivalence (BE) studies on all new formulations of drug ingredients or therapeutic molecules that have not already been approved for marketing. The goal of these studies is to ensure that generic versions perform as effectively or better than the innovator product regarding absorption, disposition, and clinical efficacy.
BA/BE studies typically employ healthy volunteers rather than patients for several reasons, including simpler inclusion and exclusion criteria, more amenable sampling schedules, no coexisting medications that might alter study results, as well as having more uniform population characteristics that make statistical analysis simpler for evaluating effects from formulation or other factors.
Medical monitors oversee the health and safety of participants enrolled in clinical trials. They monitor adverse events, review them with clinical research team members, and make recommendations based on medical science knowledge for potential trial adjustments or suspension. Furthermore, they ensure compliance with regulatory standards throughout an investigational plan or related document.
Clinical quality assurance auditors play a vital role in clinical research. Their job is to ensure that clinical trials adhere to stringent safety and compliance standards by conducting audits and inspections, reviewing regulatory documents submitted, communicating with regulatory authorities and offering advice regarding compliance issues. It requires knowledge of both the regulatory process as well as clinical trials in order to successfully fulfil this crucial function.
Beyond these roles, the clinical research industry offers many other careers you could explore. Some examples are:
Clinical Research Scientist – One of the more popular career options within clinical research involves designing and conducting clinical research. This involves creating protocols, collecting and analyzing data, writing reports, as well as working in pharmaceutical companies, universities or government agencies. You’ll find this job ideal if you possess strong analytical and communication abilities. To advance further in this career field, pursue advanced degrees or obtain certifications specific to your area of expertise – these steps will increase marketability while propelling you up the corporate ladder.
Study Design
Halle Kahlenberg made headlines as the first undergraduate clinical research student to publish her research, making an indelible mark on both her peers and industry, leading her to receive Campbell University’s inaugural Clinical Research Achievement Award.
Design of any study is of vital importance; its design should address identifying a problem, developing hypotheses and creating an experimental plan. Furthermore, direction of inquiry also influences ba/be studies in clinical research: for instance forward-direction studies track participants (such as smokers vs nonsmokers) to predict whether outcomes like lung cancer will occur at future time points; while backward-direction studies focus on exposures ( e.g. cases vs controls) as starting points and observe their correlation with outcomes like lung cancer development over time – thus shaping its design.
Clinical research professionals must abide by stringent regulatory and ethical bodies when carrying out their duties. Their tasks may include adhering to an investigational plan and study protocol, recording clinical trial information to relevant bodies, recruiting participants based on protocol-specific inclusion/exclusion criteria and performing data analyses with various analytical methods before interpreting statistical outputs derived from various analytic methods.
Sample Size
Sample size is an integral component of clinical studies, as it determines how informative the data collected will be with regards to inferential goals. In general, larger sample sizes tend to produce more informative data. However, specific goals may require different amounts of information.
Researchers testing the effectiveness of an emergency medicine training program must have enough participants in order to properly gauge its impact. Pioneers in this field recommend advanced methodological training, deliberate mentorship and research consortia as ways of conducting generalizable outcomes-based studies; additionally they emphasize providing funding and protected time to emerging researchers as part of fostering their careers.
Bioequivalence trials require sufficient samples in order to effectively compare two drugs that appear equivalent. According to regulatory bodies’ guidelines, the number of subjects must be large enough in order to yield reliable results; however, they don’t specify what constitutes sufficient size.
There are various methods available for determining sample size, such as traditional power calculations and experience-based heuristics. Heuristics provide researchers with an easy and efficient way to estimate sample sizes without extensive mathematical skills or effort required by traditional power analyses, yet do not always lead to identical conclusions as their counterpart. Heuristics rely on assumptions which may or may not hold true and lead to similar conclusions as their power equivalents.
No matter which method is employed to calculate sample size, it is critical that its results be reliable. To accomplish this, samples must reflect the population being studied while any confounding factors that could alter results must also be taken into consideration.
BE trials require samples to be comparable in terms of their absorption, distribution, metabolism and excretion (PK) properties. A BE trial does not necessarily compare two distinct medications but two formulations of one drug such as capsules versus tablets.
Data Analysis
Before any drug, vaccine, device or therapy that improves health and well-being can be prescribed or used in hospitals, it must undergo clinical trials. These trials help researchers ascertain how well and safely the medication performs; clinical research associates play an integral part here by acting as intermediaries between researchers sponsoring these trials and their study participants.
To gain more insight into how novices enter and advance within clinical research, the authors of this mixed-methods survey conducted an online survey with current graduate program students and alumni at an academic university. It was sent via an email listserv with two reminders provided to participants.
At least 83 respondents completed the three open-ended questions included in this survey, seeking information about how respondents first became interested in clinical research, how they found their first job within this field, and their advice for newcomers seeking to enter or advance in clinical research careers.
Most respondents were first introduced to clinical research through an undergraduate internship experience at their respective college or university. Some interns went on to obtain permanent positions within their department while others opted to remain as interns or transition to different sections within the research company.
Respondents without direct experience in clinical research reported discovering it through school programs or people they had met after college, although some discovered the field through happenstance. Many participants expressed enthusiasm about collaborating with patients while contributing to healthcare improvements through this field of research.
FDA guidance suggests that for those conducting PK studies on drugs that show highly variable within-subject drug concentrations (Class D drugs), BE measures should be statistically analysed on their original scale instead of being log transformed. This is important since much of the variation in PK data results from error term distribution which depends on sampling design
Bioavailability (BA) and bioequivalence (BE) studies are an integral component of drug development. They involve comparing two pharmaceutical dosage forms (test and reference) in a randomized clinical trial involving healthy volunteers to assess bioavailability (BA) or bioequivalence (BE). BE trials typically focus on adult populations; however, their findings can also be applied directly to pediatric…