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Related Concept Videos

Preclinical Development: Overview01:28

Preclinical Development: Overview

Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
Drug Administration and Therapy Phases: Overview01:26

Drug Administration and Therapy Phases: Overview

Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
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 (CHF).
Pharmacokinetic–Pharmacodynamic Relationship: Problems01:24

Pharmacokinetic–Pharmacodynamic Relationship: Problems

The empirical approach to drug therapy optimization relies on correlating pharmacological response with administered dosage. Such an approach can be costly, time-consuming, and often yields poor correlation due to variables like formulation factors and drug elimination characteristics. A more precise approach correlates response with plasma drug concentration or the amount of drug in the body, rather than dosage. This is achieved through pharmacokinetic-pharmacodynamic (PK/PD) modeling, which...
Clinical Trials: Overview01:11

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
Pharmacokinetic–Pharmacodynamic Relationship: Exposure, Response and Effect01:26

Pharmacokinetic–Pharmacodynamic Relationship: Exposure, Response and Effect

The pharmacokinetic-pharmacodynamic (PK-PD) relationship describes the intricate link between drug exposure, efficacy, and toxicity, forming the foundation for optimal dosing regimens. This relationship uses mathematical modeling to characterize drug concentration-effect dynamics, ensuring precise therapeutic outcomes.Exposure represents the pharmacokinetic aspect of the PK-PD relationship, denoting the drug amount that elicits a biological response. It is typically quantified by administered...

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Desired professional development pathways for clinical pharmacists.

1, Stacy S Shord, Terry L Schwinghammer

  • 1American College of Clinical Pharmacy, Lenexa, KS 66215, USA. stacy.shord@fda.hhs.gov

Pharmacotherapy
|February 13, 2013
PubMed
Summary

The American College of Clinical Pharmacy (ACCP) recommends postgraduate residencies and board certification for clinical pharmacists. Lifelong learning and systematic professional development are crucial for maintaining expertise and optimizing patient care.

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Area of Science:

  • Pharmacy Practice
  • Clinical Pharmacy Education
  • Professional Development

Background:

  • The American College of Clinical Pharmacy (ACCP) Certification Affairs Committee developed guidelines for clinical pharmacist professional development in 2012.
  • This document outlines recommended postgraduate education and training pathways for U.S. pharmacy graduates.

Purpose of the Study:

  • To describe preferred pathways for clinical pharmacists to achieve, demonstrate, and maintain competence.
  • To provide guidance on postgraduate education and training for clinical pharmacy practice.

Main Methods:

  • Recommendations based on established professional development models.
  • Summary of postgraduate training, including PGY1 and PGY2 residencies, fellowships, and graduate education.
  • Emphasis on lifelong learning and continuous professional growth.

Main Results:

  • Completion of an accredited PGY1 pharmacy residency is recommended post-licensure.
  • PGY2 pharmacy residency is advised for specialization.
  • Fellowship or graduate education is encouraged for research-focused pharmacists.
  • Board certification by organizations like the Board of Pharmacy Specialties (BPS) is recommended within two years of practice specialization.

Conclusions:

  • Clinical pharmacists should pursue accredited residencies and specialty certifications.
  • Lifelong learning, including traineeships and certificate programs, is essential for professional growth.
  • Collaboration with professional organizations is encouraged to develop innovative competency assessment strategies.