Course unit; Pharmaceutics
04/09/2024
Reg no. :2023-08-17899
Pharmaceutics assignment 2
2.Discover reference books such as pharmacopoeia,guidelines that can be used In pharmaceutical
studies using names,formulas they contain, measurements for drugs.
Use this information to different in a discussion between the books.[use tabulated format]
The reference books that are used in the pharmaceutical studies are categorized in three ways that is
to say; pharmacopeia, compendia and guidelines.
Reference Book Description Formulas Measurements for Usage and
Drugs Guidelines
United States Official Contains Provides Provides
Pharmacopeia compendium for monographs with standards for drug guidelines on drug
(USP) drug quality chemical names, strength, quality, compounding,
standards in the molecular purity, and dosage labeling,
U.S. formulas, and form packaging, and
structural specifications storage; includes
formulas standards for
biologics and
dietary
supplements
British Official drug Includes Detailed Offers guidelines
Pharmacopoeia reference in the international measurements for on drug quality
(BP) UK, also used nonproprietary drug purity, control, analysis,
internationally names (INNs), potency, and and preparation;
chemical names, physical widely used in
molecular properties Europe and
formulas Commonwealth
countries
International Issued by the Covers Focuses on Aims to
Pharmacopoeia World Health international measurements for harmonize quality
(Ph. Int.) Organization names, formulas, quality, safety, standards
(WHO) to and structural and efficacy of worldwide,
promote uniform details of drugs medicines especially in low
standards globally and excipients and middle-
income countries
Martindale: The Comprehensive Includes chemical Provides Offers guidelines
Complete Drug drug reference names, formulas, information on on the clinical use
Reference book providing trade names, and dosage forms, of drugs,
details on drugs synonyms for strength, and pharmacology,
available drugs therapeutic use and drug
internationally interactions; used
widely in
hospitals and
clinical settings
WHO Guidelines Provides General Discusses Offers guidelines
on standards and reference, not measurements for on the
Pharmaceutical recommendations focused on bioavailability, development,
Development for the specific names or stability, and assessment, and
development of formulas efficacy regulatory
new approval of new
pharmaceutical drugs, focusing on
products quality, safety,
and efficacy
Good International Not specifically Focuses on Details
Manufacturing guidelines for focused on names measurements procedures and
Practice (GMP) pharmaceutical or formulas but related to processes to
Guidelines production to includes production quality maintain
ensure products requirements and batch consistent
are consistently related to APIs consistency manufacturing
high in quality and excipients quality, from raw
materials to
finished products
Comparison
Pharmacopoeias (USP, BP, Ph.);These reference books are primarily focused on setting standards for
the identity, strength, quality, and purity of medicines. They contain detailed monographs that
provide chemical names, formulas, and measurements for drug substances and excipients. Each
pharmacopoeia may vary slightly in its standards based on regional regulatory requirements but
generally aims for harmonization to ensure drug quality and safety.
Drug Compendia (Martindale): These books provide comprehensive information about drugs,
including chemical names, formulas, clinical use, dosing, and therapeutic indications. They are less
focused on the manufacturing standards and more on the clinical application and pharmacological
properties of Drugs.
Guidelines (GMP, GCP, WHO Guidelines): These documents are more focused on the processes
involved in drug development, manufacturing, and clinical trials rather than specific drug
measurements or formulas. They provide standardized practices to ensure that pharmaceutical
products are consistently produced and controlled to the quality standards appropriate for their
intended.
In conclusion; pharmacopoeias focus on the chemical and physical properties of drugs, compendia like
Martindale provide clinical and therapeutic information, and guidelines focus on regulatory, safety,
and quality aspects of drug production and clinical trials.
