Results 111 to 120 of about 26,646 (226)

Highly variable medicines - specific aspects of bioequivalence studies

Регуляторные исследования и экспертиза лекарственных средств, 2018
At present a specific group of medicines - highly variable medicines - is distinguished based on intraindividual variability data (CVintra > 30%). It is quite difficult to confirm therapeutic equivalence of highly variable medicines by pharmacokinetic ...
D. P. Romodanovsky, T. V. Eremenkova, M. A. Dranitsyna, D. V. Goryachev, R. R. Niyazov, E. V. Gavrishina, V. A. Merkulov   +6 more
doaj  

Demystifying bioequivalence [PDF]

Medical Journal of Australia, 2014
openaire   +2 more sources

One of These Things Is Not Quite the Same: A Comparison of the Patent Doctrine of Equivalents with Suitability for Filing an Abbreviated New Drug Application [PDF]

, 2012
The doctrine of equivalents as applied to chemical patents is compared to the FDA’s findings of bioequivalence in reviewing suitability petitions for filing Abbreviated New Drug Applications (ANDAs).
Halstead, David P.
core  

Bioequivalence testing of topical dermatological formulations, the gap between science and legislation [PDF]

, 1998
Bioavailability concerns for topical dermatological products are complex and it is especially difficult to determine the bioequivalence of similar topical formulations.
Haigh, J M, Schwarb, F P, Smith, E W, Surber, C   +3 more
core   +1 more source

Bioequivalence Analysis of Terazosin Hydrochloride Tablets Based on Parallel Artificial Membrane Permeability Analysis

Pharmaceuticals
Parallel artificial membrane permeability analysis (PAMPA) is used to determine the permeability of compounds through concentrated negatively charged phospholipid bilayer barriers.
Jianzhao Niu, Hanhan Huang, Ming Ji, Wenjing Zhang, Yin Huang, Lingyun Ma, Baolian Wang, Qian Liu   +7 more
doaj   +1 more source

Problems of bioanalytical part of bioequivalence studies of drugs in Russia

Фармакокинетика и Фармакодинамика, 2014
In the review of the main problems holding bioanalytical part of bioequivalence studies of medicines in Russia. The analysis of the major causes of failure when performing studies of bioequivalence and pharmacokinetics.
A. L. Khokhlov, E. G. Lileeva, O. A. Sinitsyna, S. A. Speshilova, S. M. Demarina, L. N. Shitov   +5 more
doaj  

Bioequivalence and Safety Assessment of Brivaracetam Dry Syrup Compared With Tablets in Healthy Japanese Participants: Results From Two Randomized Single- and Multiple-Dose Trials. [PDF]

Clin Pharmacol Drug Dev
Hayakawa Y, Yoshinaka R, Sano T, Krauwinkel W, Soma T, Sasamoto H, Elshoff JP, Bass A, Chen Y, Kurihara N, Murakami H.   +10 more
europepmc   +1 more source

Single-Dose Bioequivalence Study of Elagolix Tablets 200 mg (Test Product) and Elagolix Tablets 200 mg (Reference Product) in Healthy Non-Pregnant, Non-Lactating Premenopausal Female Subjects Under Fasting Conditions. [PDF]

Clin Pharmacol Drug Dev
Kumar S, Khuroo A, Quadros R, Dharmadhikari S, Khandhedia C, Puppalwar G, Mane A.   +6 more
europepmc   +1 more source

Bioequivalence [PDF]

, 2020
openaire   +1 more source

Bioequivalence study of testosterone undecanoate soft capsules in healthy postmenopausal women under fed conditions: a single-center, four-period, repeated crossover trial. [PDF]

Front Pharmacol
Li N, Zhu F, Zhao Z, Zhu S, Wu J, Zuo X, Shi J, Qian X, Zhang X, Hu Y, Lv Y, Chen J, Zhang T.   +12 more
europepmc   +1 more source