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Bioanalytical technique: a quality check for pharmaceutical dosage forms

Helal Uddin, A.B.M. (2023) Bioanalytical technique: a quality check for pharmaceutical dosage forms. In: 3rd International Conference on New Horizon in Drug Discovery and Development Process, 23 Feb 2023, Kolkata, India. (Unpublished)

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Quality, safety and efficacy these are the endeavours required to be addressed meticulously for any drug development process. World regulatory agencies are repeatedly and continuously reminding the pharmaceutical manufacturer to abide by these three major requirements for any dosage form preparation either new drug entity or imitated generic drug. Bioavailability of drugs at target sights considered as a major indicator of the quality and efficacy of any therapeutic agent. Bioavailability of drug is often evaluated by bioequivalence (BE) of the drug with the reference drugs or already tested drugs. Bioanalysis of drug substances plays a critical role to determine the effectiveness of the bioequivalence results. In Malaysia, the regulatory agency responsible for overseeing the approval of drugs and ensuring their quality, safety, and efficacy is the National Pharmaceutical Regulatory Agency (NPRA). Bioequivalence result is important for the evaluation of generic drugs and NPRA follows the guidelines set by the World Health Organization (WHO) for determining bioequivalence. Thus, bioanalytical techniques become the key quality checking tool for the determination of the quality and efficacy of any drug dosage forms. At IIUM, we strive towards the excellence of quality manufacturing of drug dosage forms through its PICS GMP compliant manufacturing plant IKOP Sdn Bhd. NPRA requires that generic drugs demonstrate bioequivalence to their reference listed drug before they can be approved for sale and use in Malaysia. To comply with the NPRA requirement we have developed several bioanalytical assay for different classes of drugs such as antihypertensive, antidiabetic, NSAID, antihistamin etc. Different HPLC and LCMS technique was adopted to develop and validate bioanalytical technique for the determination of drugs in human plasma or serum. Design of experiment was used to optimise the extraction technique for a better sample preparation. USFDA, EMA, ICH and ASEAN BE guideline was followed for the development and validation of the bioanalytical techniques.

Item Type: Proceeding Paper (Keynote)
Additional Information: 4478/108961
Uncontrolled Keywords: bioavailability, bioequivalence, bioanalysis, NPRA, Malaysia
Subjects: Q Science > QD Chemistry
R Medicine > RM Therapeutics. Pharmacology
R Medicine > RS Pharmacy and materia medica
R Medicine > RS Pharmacy and materia medica > RS192 Materia Medica-Pharmaceutical Technology
R Medicine > RS Pharmacy and materia medica > RS403 Materia Medica-Pharmaceutical Chemistry
Kulliyyahs/Centres/Divisions/Institutes (Can select more than one option. Press CONTROL button): Kulliyyah of Pharmacy
Depositing User: Dr. A. B. M. Helal Uddin
Date Deposited: 04 Jan 2024 12:43
Last Modified: 04 Jan 2024 12:43
URI: http://irep.iium.edu.my/id/eprint/108961

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