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Currently, the center is pursuing straightforward Bio-Equivalency studies.
However, very shortly, the center intends to offer a wide range of services to guide pharmaceuticals, it intends to provide clinical research (Phase II/III and IV clinical trials) based on Good Clinical Practice.
Presently, Pharmacokinetics and Bio-equivalence services include Preclinical service, single dose toxicity, repeated dose toxicity. Protocol development, Subject recruitment, analysis and interpretation of statistical data, data management, pharmacokinetics studies, single dose and multiple dose pharmacokinetics, dose proportionality studies, feasibility studies.
Studies carried out on Systemic exposure profile determining, during clinical trials in the IND period, which serves as a benchmark for subsequent BE studies. Carrying out Non Regulatory and Regulatory IND for pre clinical service development.
For BE studies, the center compares the systemic exposure profile of a test drug product, to that of a reference drug product (RLD) to determine, orally administered drug products to be bioequivalent. To compare and determine, whether, active drug ingredient or active moiety in the test product is exhibiting the same rate and extent of absorption as the reference drug product.
Ethical Team and Regulatory Support Service: The center is highly equipped to conduct bioequivalence trials, bio-analytical method development and validation, data management, pharmacokinetics and biostatistics, etc. Since bioequivalence focus on the release of a drug substance from its dosage form and subsequent absorption into the systemic circulation, an independent seven-member Ethical Committee (comprising of medical experts, a lawyer, a Clergy (Imam) and a layman) exists at the Khwaja Yunus Ali Medical College Hospital to approve the study, to oversee regulatory affairs and report.