Clinical Program Courses - PharmD
PAC 101 - Pharmaceutical Analytical Chemistry I (2+1)
Chemical Kinetics, rate of reaction, first Order reaction, rate law ,
Second order and third order of reaction, molecularity , Theories of
reaction rate, activation energy and catalysis , Photochemistry,
absorbed energy and quantum yield.Introduction to qualitative and quantitative inorganic chemistry, acidbase theory, titration curve and buffer solutions. Precipitimetry factors
affecting precipitate formation and pharmaceutical application.
PAC 202 - Pharmaceutical Analytical Chemistry II (2+1)
Complexometric titrations and oxidation-reduction titrations (electrical
properties of redox systems, Nernest equation factors affecting
oxidation potential, redox titration curves, pharmaceutical application
on redox reaction), Electrochemistry (potentiometry, conductometry;
and polarography).
PAC 703 - Quality Control of Pharmaceuticals (2+1)
The course is shared with departments: Microbiology & Chemistry :
I- Quality control & quality assurance of pharmaceuticals .
The course has to be designed for quality control
microbiology professionals, quality assurance or regulatory affairs
personnel who have responsibility for the performance of Bioburden,
Endotoxin & Sterility Testing or for data review, pharmacists
performing sterile compounding.Principles, methods and procedures
of different quality control tests used for evaluation of safety, potency
and palatability of pharmaceutical products of small and large
molecules drugs (biologicals) including herbal drugs have to be taught.
The standard pharmacopeial methods and procedures as well as
international guidelines as WHO, EMA, TGA should be discussed.
II-Good Analytical Practice and Sampling: Introduction, Sampling of
pharmaceuticals and related materials, Type of sampling tools,
Sampling plans.
III-Documentation
IV- Validation of analytical methods according to ICH Guidelines Q2
R1. Compendial testing , Validation of analytical methods, Data
elements required for assay validation.
V- drug stability, stability studies and stability indicating methods Drug
stability, Stability testing , Forced degradation studies , stability
indicating assay methods for drugs according to ICH Q1 R2
Guidelines. Stress conditions for drug degradation according to ICH Q1
R2 Guidelines. Factors affecting drug degradation, Drug expiration,
Drug withdrawal from the market. Pharmaceutical regulations
according to FDA & EMA (European medicine agency) and ISO and
BSI. Drug-excipient interactions and adduct formation; analytical
techniques used to detect drug-excipient compatibility, mechanism of
drug-excipient interactions, examples.
VI- Official methods of analysis applied to raw materials and end
products.
PAC E04 - Advanced Pharmaceutical Analysis (1+1)
Electromagnetic radiation- UV and visible light- molecular absorptionBeer’s Lambert Law- Monochromatic light and monochromators Spectrophotometer- deviation from Beer’s Lambert Law- Job’s
method- serial dilution- Calibration curve and determination of
unknown- Fluorimetry- difference between fluorimetry and
phosphorescence- Stoke’s shift- factors affecting Fluorescence -
Spectrofluorimeter- atomic spectroscopy- atomic absorption- atomic
emission.