Twelve recommendations for integrating existing systematic reviews into new reviews: EPC guidance

Karen A Robinson1, Roger Chou2, Nancy D Berkman3

  • 1Johns Hopkins University, 1830 E. Monument St, Suite 8068, Baltimore, MD 21287, USA.

Abstract

Related Concept Videos

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions01:15

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure...
72
Clinically Relevant Drug Product Specifications: Methods of Establishment01:29

Clinically Relevant Drug Product Specifications: Methods of Establishment

Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
285
Standards of Care II01:19

Standards of Care II

Nurses bear specific legal responsibilities under several federal statutes, including:
1.2K
Dosage Regimens: Designs and Approaches01:28

Dosage Regimens: Designs and Approaches

Designing a dosage regimen, which refers to the manner of drug administration, is a complex process involving the selection of drug dose, route, and frequency. This process is underpinned by pharmacokinetic parameters derived from tests and population averages. These parameters are then tailored to patient-specific variables such as diagnosis, demographics, and allergy status. Once therapy commences, therapeutic response monitoring is critical and achieved through clinical and physical...
477
Study Designs in Epidemiology01:20

Study Designs in Epidemiology

Epidemiological study designs are fundamental tools for investigating the distribution, determinants, and control of health conditions in populations. They help researchers understand the relationships between exposures and outcomes, and they broadly fall into two categories: "observational" and "experimental" studies.
Observational studies are those where the researcher does not intervene but rather observes natural variations. They include cross-sectional, cohort, and...
1.6K
Methods of Documentation VII: EMR01:30

Methods of Documentation VII: EMR

Electronic Medical Records (EMRs) primarily center around electronically documenting patients' health information within a single healthcare organization or practice. They contain essential clinical data related to a patient's medical history, diagnoses, medications, treatment plans, lab results, and other pertinent information relevant to the specific encounter or episode of care. EMRs are designed to streamline documentation and workflow processes within individual healthcare...
1.6K