PARENTERAL ADMINISTRATION
2. An IV solution must be made in the pharmacy and delivered to the floor. It consists of 20 mEq of potassium chloride in a liter of dextrose 5% in…
CONCENTRATION AND DILUTION
Beginning with % w/v, which is the most common concentration form, the active ingredient is usually a solid that is expressed in grams. In % v/v (usually seen with alcoholic…
MILLIEQUIVALENT CALCULATIONS
[Note: This equation is the shortcut of the following: Then, this last equation is converted to milliequivalents (mEq) by dividing both sides by 1000, which yields the equation above. As…
BASIC MATHEMATICS REVIEW
Although capital letters are commonly used in this system, lower case letters are also seen to depict Roman numerals. Practice Exercises Convert the following Roman numerals to their Arabic equivalent…
OFTEN USED PHARMACY AND MEDICAL ABBREVIATIONS
Practice Exercises Interpret the following: 1. Sig: ii cap q4h 2. i tab qid c food 3. i tsp tid 4. 1 mL SC q24h 5. 1-2 cap q4-6h…
DOSAGE CALCULATIONS
Dose = 1.75 mg/kg × 106.4 kg × 4 hours = 744.8 mg 5. 1250 mg/m2 po bid × 2 weeks, 1 week off then repeat for 3 cycles. BSA…
Pharmacovigilance Medical Writing for Marketed Products
5.1 Introduction Once a medicinal product has been approved for marketing, the marketing authorization holder (MAH) has an obligation to periodically submit a number of pharmacovigilance reports to relevant regulatory…
Pharmacovigilance Medical Writing for Marketing Authorization
3.1 Introduction The process of pre-authorization clinical development is considered complete when the sponsor has collated sufficient evidence of efficacy and safety for the investigated medicinal product. Thereafter, it is…
Pharmacovigilance Medical Writing in Risk Evaluation and Management
4.1 Introduction The pharmacovigilance documents associated with risk evaluation and management are often required components of Marketing Authorization Application (MAA) and New Drug Application (NDA) submissions, and thus could have…
The ad-hoc Safety Review and Response to Questions Document
6.1 Introduction In addition to the multiplicity of mandated periodic pharmacovigilance documents required for investigational and authorized medicinal products, documents submitted at the time of application for marketing authorization, and…
