DRC Regulations
DRC perform Bioequivalence studies based on CAPA regulations & international regulations on Good Clinical Practice, provided by benchmark regulatory bodies like World Health Organization (WHO), U.S Food & Drug Administration (FDA), EMEA (European Agency For The Evaluation Of Medicinal Products) and ICH (International Conference Of Technical Requirements For The Registration Of Pharmaceuticals For Human Use). Moreover, the bioequivalence studies are conducted in accordance with the international ethical guidelines for clinical studies in humans set out in the declaration of Helsinki, as well as with the latest guidelines on Good Clinical Practice in so far as they do not intervene with the Egyptian guidelines.
|
Bioequivalence Studies -The Ethical Committee carefully review all submitted documents and provide its view of the proposed study protocol in a written document within a reasonable time. -Informed Consent Form: of a clinical trial is adhere to the ethical principles. -DRC is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs to ensure that trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory requirement(s) -DRC Technical Manager is responsible for securing agreement from all involved parties to ensure direct access to all trial- source data/documents, and reports for the purpose of monitoring and auditing by herself and inspection by regulatory authorities Summary of Bioequivalence Study protocol I.Introduction: II.Guidelines for carrying out Bioequivalence studies A. Investigator qualification and Agreements B. Protocol: 1-Selection of investigators 2-Informed consent: 3-Number of subjects 4-Selection of subjects 5-Inclusion criteria/ Exclusion criteria III. Laboratory tests must include the following: Blood Chemistry Hematological test Urine Analysis IV. Study Design a. Raw Material Identification. b.Stage (I): 1-Identification 2- Potency 3- Content uniformity 4- Weight Variation |
|
|
5-Dissolution Testing c. Stage (II) 1-Validation of Analytical Method 2-Major validation steps d- Study Conduct 1-Selection of dose 2-Sampling times 3-Sample collection e. Stage (IV): 1-Vivo Testing 2-Restrictions 3-Procedure 4-Blood Sampling 5-Subject Monitoring 6-Clinical Report, Side Effects and Adverse Reactions f. Stage (V) 1-Pharmacokinetic analysis 2-Statistical Analysis 3-Equivalence Criteria g. Stage (VI): 1-Presentation of Data 2-Statistical analysis of pharmacokinetic Reserve of samples 3-Approval
|