Generics, Chemisimilars and Biosimilars: is clinical testing fit for purpose?
Summary of "Generics, Chemisimilars and Biosimilars: is clinical testing fit for purpose?"
The effectiveness and safety of generic drugs is backed by sound physicochemical control and regulatory bioequivalence acceptance criteria. Statistical testing of bioequivalence, comparing the pharmacokinetic profiles of the test and reference products, was made possible by modern drug assays. When the pharmacokinetic profile correlates with the dose, such comparisons show assay sensitivity and readily detect differences in dose. For large biological molecules different manufactured batches cannot be validated using pharmacokinetic data alone. For these biosimilars there is a three stage assessment of pharmaceutical quality, laboratory testing and clinical data. This approach has also been applied to certain chemical products, termed "chemisimilars", which have variable or complex synthesis of the active substance, or complex formulation, or a complex delivery device. Though there may be no detectable difference between the test and reference on clinical testing, many of the outcome measures are insensitive to even large differences in dose. For testing to be fit for purpose it should distinguish important dose differences, but many clinical tests of chemisimilars and biosimilars do not. As pharmacokinetic and pharmacodynamic technology advances the trend of replacing dose insensitive clinical trial data with equivalence tests that show assay sensitivity can be expected to continue. © 2012 The Author. British Journal of Clinical Pharmacology © 2012 The British Pharmacological Society.
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This article was published in the following journal.
Name: British journal of clinical pharmacology
- PubMed Source: http://www.ncbi.nlm.nih.gov/pubmed/22574725
- DOI: http://dx.doi.org/10.1111/j.1365-2125.2012.04323.x
Medical and Biotech [MESH] Definitions
A form of LEPROSY classified by the World Health Organization for the purpose of treatment, based on clinical manifestations and skin smear results. Patients with paucibacillary leprosy have fewer than six skin lesions with no causative agent MYCOBACTERIUM LEPRAE on any slit-skin smear testing. Paucibacillary leprosy encompasses indeterminate, borderline tuberculoid, and tuberculoid leprosy.
Detection of or testing for certain ALLELES, mutations, genotypes, or karyotypes that are associated with genetic traits, heritable diseases, or with a predisposition to a disease, or that may lead to the disease in descendants. It includes prenatal genetic testing.
Process that is gone through in order for a drug to receive approval by a government regulatory agency. This includes any required pre-clinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance of the drug.
Testing in which the source of the specimen or the person being tested is not individually identified.
An indolesulfonic acid that is used as a dye in renal function testing and as a reagent for the detection of nitrates and chlorates and in the testing of milk.
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