Research Design

Bioequivalence Study

study compares the bioavailability of a generic drug formulation to that of a reference (brand-name) drug. It demonstrates therapeutic equivalence by analyzing pharmacokinetic parameters and ultimately determines whether the generic formulation can serve as a substitute for the brandname product.

1. Compares pharmacokinetic parameters (AUC, Cmax, Tmax)

2. Usually employs crossover design

3. Focuses on rate and extent of absorption

4. Requires fewer subjects than efficacy trials

5. Typically conducted in healthy volunteers

Distinct Characteristics of Bioequivalence Study

Case report

a detailed description of a single patient’ s condition, treatment, and outcome. It is used in research to share unique or rare medical cases, new treatments, or unexpected side effects. Case reports help doctors and researchers learn from real-life experiences but do not provide strong evidence like larger studies.

1. Focus on a single patient

2. No comparison group

3. Low in hierarchy of evidence

4. Highly detailed clinical description

5. Often first indication of new findings

Distinct Characteristics of Case Report

Case Series

a report on a collection of patients who share the same condition, documenting clinical experiences with multiple similar cases. It provides valuable insights into disease patterns, treatment responses, and potential risk factors, though it lacks a control group for comparison.

1. Multiple similar cases

2. No control group

3. Descriptive rather than analytical

4. Can generate hypotheses for future studies

5. No statistical comparisons between groups

Distinct Characteristics of Case Series

Case Control Study

a retrospective research design that compares individuals with a specific outcome (cases) to those without it (controls). It aims to identify factors associated with the condition or outcome by working backward from the observed effect to potential causes. This method is particularly useful for studying rare diseases or outcomes with long latency periods.

1. Starts with outcome and looks backward to find exposures

2. Particularly useful for rare diseases

3. Subject to recall bias

4. Uses odds ratios as measure of association

5. Relatively quick and inexpensive

Distinct Characteristics of Case Control Study

Clinical Study

—broad term for research studies involving human subjects. It evaluates biomedical or health-related outcomes and may be interventional or observational

1. Umbrella term covering many specific designs

2. Interventional or observational

3. Focus on clinical endpoints

4. Human subjects

5. Usually requires ethical approval

Distinct Characteristics of Clinical Study

Cohort Study

an observational research design that follows a group of individuals (cohort) over time to assess the relationship between exposures and outcomes. Participants are classified based on their exposure to a certain factor and are observed to determine the incidence of a specific outcome.

1. Prospective or retrospective

2. Starts with exposure and follows to outcomes

3. Allows calculation of incidence rates

4. Can study multiple outcomes

5. Less subject to selection bias than case-control studies

Distinct Characteristics of Cohort Study

Cross Sectional Study

examines data from a population at a single point in time. It provides a " snapshot" of prevalence and associations, and it cannot establish temporal relationships

1.NO follow-up (snapshot)

2.Can establish prevalence but not incidence 3.Cannot determine causality

4.Relatively quick and inexpensive

5.Can study multiple exposures and outcomes simultaneously

Distinct Characteristics of Cross Sectional Study

Meta-analysis

a statistical method combining results from multiple studies, this kind of study increases statistical power and improves precision hence providing an accurate overall effect estimate.

1. Quantitative synthesis of research findings

2. Uses statistical methods to combine data

3. Higher level of evidence than individual studies

4. Provides measure of effect size

5. Includes assessment of heterogeneity

Distinct Characteristics of Meta-analysis

Post Marketing Surveillance

involves monitoring drug safety after regulatory approval, identifies adverse events in real-world use, and evaluates longterm outcomes in broader populations.

1. Real-world data after drug approval

2. Large population exposure

3. Can detect rare adverse events

4. Passive and active surveillance methods

5. Longer-term follow-up than pre-approval trials

Distinct Characteristics of Post Marketing Surveillance

Qualitative Systematic Review

a comprehensive synthesis of findings from qualitative studies. It explores experiences, perceptions, and meanings. It also uses interpretive rather than statistical methods.

1. Focuses on qualitative research only

2. Interpretive rather than statistical synthesis

3. Explores experiences, perceptions, and meanings 4. Thematic analysis common

5. No statistical pooling of data

Distinct Characteristics of Qualitative Systematic Review

Stability Study

evaluates how the quality of a drug substance or product varies over time. It tests different environmental conditions and storage parameters. This study determines shelf life and storage recommendations.

1. Focus on pharmaceutical properties

2. Predetermined storage conditions

3. Specific testing intervals

4. Evaluates degradation patterns

5. Determines shelf life and storage recommendations

Distinct Characteristics of Stability Study

Randomized Control Trial

an experimental study where participants are randomly assigned to groups. This tests interventions against control conditions. It is considered the GOLD STANDARD for evaluating efficacy and safety.

1. Random allocation to groups

2. Controls for known and unknown confounders

3. Gold standard for testing interventions

4. Can be blinded (single, double, triple)

5. Provides strongest evidence for causality

Distinct Characteristics of RCT

Quasi-Experimental Study

resembles an experimental study but lacks random assignment of participants to groups. It evaluates the impact of an intervention on an outcome by comparing groups that are not randomly assigned. It is also commonly used when randomization is impractical or unethical, and it provides stronger evidence than observational studies but is more prone to confounding than true experiments.

1. No random allocation of participants

2. Independent variable is manipulated

3. Lower internal validity than randomized controlled trials (RCTs) due to potential confounding.

4. Higher external validity since it reflects real-world conditions.

5. Common in healthcare, education, and public policy research.

Distinct Characteristics of Quasi-Experimental Study

Systematic Review

a structured, comprehensive synthesis of research literature that follows explicit, reproducible methods to identify, evaluate, and summarize all relevant studies on a specific question.

1. Clearly defined research question using frameworks like PICO (Population, Intervention, Comparison, Outcome)

2. Comprehensive search strategy documented in detail to ensure reproducibility

3. Explicit inclusion and exclusion criteria for study selection

4. Critical appraisal of included studies using validated tools to assess quality and risk of bias

5. Transparent synthesis methods (qualitative or quantitative) with clear reporting of findings

Distinct Characteristics of Systematic Review

.Protocol Development

Creating a detailed plan registered in databases like PROSPERO before beginning the review to prevent arbitrary decision-making

Systematic Searching

Using multiple databases (PubMed, Embase, CINAHL) with Boolean operators and controlled vocabulary terms, supplemented by hand-searching reference lists

Dual Independent Screening

Having two reviewers independently assess titles, abstracts, and full texts against criteria with a third reviewer resolving disagreements

Data Extraction

Using standardized forms to systematically collect relevant information from included studies to ensure consistency

Meta-Analysis

Statistically combining quantitative data from comparable studies to calculate pooled effect estimates with confidence intervals