PdF lec Flashcards
Is defined as an agent intended for use in the diagnosis, mitigation, treatment, cure, or prevention of disease in human or in other animals.
Drugs
has been defined as the profession which is concerned with the art and science of preparing drugs either from natural or synthetic sources in a suitable and convenient dosage form for administration of treatment, and prevention of diseases both of man and animals.
Pharmacy
The word Pharmacy is derived from the Greek word _______, meaning medicine or drug.
Pharmakon
is the person considered the expert on drugs
Pharmacist
Are pharmaceutical drug products in the form in which they are marketed for use, with a specific mixture of active ingredients and inactive components in a particular configuration, and apportioned into a particular dose.
DOSAGE FORMS
According to Stedman’s medical dictionary, ________ is the giving of medicines or other therapeutic agent in prescribed amount.
DOSAGE
Is a preparation devised to make possible the administration of medications in measured or prescribed amounts.
Dosage
Is any device intended to be used for medical purposes. Medical devices benefit patients by helping health care providers diagnose and treat patients and helping patients overcome sickness or disease, improving their quality of life.
Medical Device
is a noun to denote preparations of such nature.
Pharmaceuticals
THE HERITAGE OF PHARMACY:
4
The First Apothecary
Introduction of the Scientific Viewpoint
Early Drugs
Early Research
DRUG STANDARDS: 2
USP
NF
USP means
United States Pharmacopoeia
NF means
National Formulary
New Drug Development
NPIPCNP
1. New Chemical Entity (sources)
2. Preclinical Studies
3. Investigational New Drug Application (IND)
4. Preclinical Studies (continued #2)
5. Clinical Trials
6. New Drug Application (NDA)
7. Post Marketing
- New Chemical Entity (sources) : 3
Organic synthesis
Molecular Modification
Isolation from Plants
- Preclinical Studies
Chemistry
Physical Properties
Preformulation
Biological
(Pharmacology, toxicology)
- Investigational New Drug Application (IND)
Submission
FDA Review
- Preclinical Studies (continued #2)
Long-term Animal Toxicity
Product Formulation
Manufacturing and Controls
Package and Label Design
- Clinical Trials
Phase I Phase II Phase III
- New Drug Application (NDA)
Submission
FDA Review
FDAAction
Pre-approval Plant Inspection
- Post Marketing
Phase IV Clinical Studies
(Clinical Pharmacology/Toxicology)
Product Defect Reporting
Product Line Extension
Adverse Reaction Reporting
General Considerations in designing of Dosage Forms
A. Preformulation Studies
B. Drug and Drug Product Stability
C. Definition and Types
D. Handbook of Pharmaceutical Excipients
E. Harmonization of Standards
F. Appearance and Palatability
G. Preservatives
A. Preformulation Studies
Solubility
Solubility and Particle
Physical Description Size
Microscopic Examination
Melting Point Depression
The Phase Rule
Particle Size
Polymorphism
Solubility and pH
Dissolution
Membrane
Permeability
Partition Coefficient
pKa/Dissolution
Constants
B. Drug and Drug Product Stability
Drug stability: Mechanism of Degradation
Drug and Drug Product Stability: Kinetics and
Shelf Life
Rate Reactions
Q10 Method of shelf-Life Estimation
Enhancing Stability of Drug Products
Stability Testing
Pharmaceutic Ingredients:
C. Definition and Types
D. Handbook of Pharmaceutical Excipients E. Harmonization of Standards
F. Appearance and Palatability
G. Preservatives
F. Appearance and Palatability
Flavoring and Sweetness Pharmaceuticals
Coloring
G. Preservatives
Sterilization and Preservation
Preservative Selection
General Preservative Considerations
Mode of Action
Preservation Utilization