- Tsrlinc Bcs
- Tsrlinc Bcs Classification
- Bcs Classification System
- Bcs Classification Database Vs
- Bcs Classification Database Structure
BIOPHARMACEUTICS CLASSIFICATION SYSTEM (BCS) BASED BIOWAIVER APPLICATION FORM AUG-20 Subject Page 5 Biopharmaceutics Classification System (Bcs) Based Biowaiver Application Form6.39V2 Page 5 2 SUMMARY: REQUIREMENTS AND OUTCOMES (FOR SAHPRA USE ONLY) Requirements Outcome Therapeutic range (and dose) Narrow / Non-narrow.
- The BCS classification system is based on the scientific rationale that, if the highest dose of a drug candidate is readily soluble in the average fluid volume present in the stomach (250 ml) and the drug is more than 85% absorbed, then the in vitro drug product dissolution profiles should allow assessment of the equivalence of different drug.
- Based in Ann Arbor, Michigan, TSRL's Technology Accelerator creates value by providing a combination of business and scientific expertise, infrastructure, and wet-lab data to take drug-therapy concepts to business formation or licensing-readiness.
- WHO Drug Information Vol. 1, 2016 2 Pre-publication draft - page numbers are not for citation purposes 72 Misoprostol dispersion 76 Misoprostol tablets 79 Carbamazepine 84 Carbamazepine tablets 87 Carbamazepine chewable tablets 90 Carbamazepine oral suspension International Nonproprietary Names (INN) 93 Recommended INN: List 75 Continued Abbreviations and web sites.
The BCS classification system is used to categorize drugs and serves to help anticipate whether drugs will have bioavailability/ bioequivalence problems. BCS classifies drugs according to their solubility and permeability. A drug is considered to have high solubility if drug substance at the highest dose strength for an immediate release formulation can be dissolved in < 250 mL of water over a pH range of 1-7.5. A high permeability drug is one that has either complete intestinal absorption (fa > 90%) or exhibits rapid movement through intestinal epithelia cells in vitro. BCS classifies all drugs into four categories as shown in Table 3.3.
Table 3.3. Biopharmaceutics classification system
BCS CLASS I High solubility High permeability
BCS CLASS III High solubility Low permeability
BCS CLASS II Low solubility High permeability
BCS CLASS IV Low solubility Low permeability
Tsrlinc Bcs
BCS class I compounds (high solubility and permeability) are unlikely to show bioavailability/bioequivalence issues. Therefore, for BCS class I drugs, in vitro dissolution studies are thought to provide sufficient information to assure in vivo product performance making full in vivo bioavailability/bioequivalence studies unnecessary. BCS class II and III drugs are not eligible for biowavers due to anticipated formulation differences in oral exposure. BCS class IV compounds, in general, are problematic with both poor solubility and permeability. The following tables (see Tables 3.4-3.7) contain lists of drugs that are categorized as BCS classes I to IV.
Abacavir | Diazepam | Ketorolac | Phenobarbital |
Acetaminophen | Diltiazem | Ketoprofen | Phenylalanine |
Diphenhydramine | Labetolol | Prednisolone | |
Amiloride | Disopyramide | Primaquine | |
Amitryptyline | Doxepin | Levofloxacin | Promazine |
Antipyrine | Doxycycline | Lidocaine | Propranolol |
Atropine | Enalapril | Lomefloxacin | Quinidine |
Ephedrine | Meperidine | Rosiglitazone | |
Caffeine | Ergonovine | Metoprolol | Salicylic acid |
Captopril | Ethambutol | Metronidazole | |
Chloroquine | Ethinyl estradiol | Midazolam | Valproic acid |
Chlorpheniramine | Fluoxetine | Minocycline | Verapamil |
Cyclophosphamide | Glucose | Misoprostol | Zidovudine |
Desipramine | Imipramine | Nifedipine |
Adapted from Wu and Benet (2005)
Adapted from Wu and Benet (2005)
Amiodarone | Diclofenac | Itraconazole | Piroxicam |
Atorvastatin | Diflunisal | Ketoconazole | Raloxifene |
Azithromycin | Digoxin | Lansoprazole | Ritonavir |
Carbamazepine | Erythromycin | Lovastatin | Saquinavir |
Carvedilol | Flurbiprofen | Mebendazole | Sirolimus |
Chlorpromazine | Glipizide | Naproxen | Spironolactone |
Cisapride | Glyburide | Nelfinavir | Tacrolimus |
Ciprofloxacin | Griseofulvin | Ofloxacin | Talinolol |
Cyclosporine | Ibuprofen | Oxaprozin | Tamoxifen |
Danazol | Indinavir | Phenazopyridine | Terfenadine |
Dapsone | Indomethacin | Phenytoin | Warfarin |
Adapted from Wu and Benet (2005)
Adapted from Wu and Benet (2005)
Table 3.6. BCS class III compounds (high solubility, low permeability)
Acyclovir
Amiloride
![Classification Classification](/uploads/1/1/9/4/119400496/452183290.jpg)
Amoxicillin
Atenolol
Atropine
Bisphosphonates
Bidisomide
Captopril
Cefazolin
Cetirizine
Cimetidine
Ciprofloxacin
Cloxacillin
Dicloxacillin
Tsrlinc Bcs Classification
Erythromycin
Famotidine
Fexofenadine
Folinic acid
Furosemide
Ganciclovir
Hydrochlorothiazide
Lisinopril
Methotrexate
Nadolol
Pravastatin
Penicillins
Ranitidine
Tetracycline
![Bcs Bcs](/uploads/1/1/9/4/119400496/485223250.png)
Trimethoprim
Valsartan
Zalcitabine
Adapted from Wu and Benet (2005)
Bcs Classification System
Amphotericin B | Furosemide |
Chlorthalidone | Hydrochlorothiazide |
Chlorothiazide | Mebendazole |
Colistin | Methotrexate |
Ciprofloxacin | Neomycin |
Bcs Classification Database Vs
Adapted from Wu and Benet (2005)
Adapted from Wu and Benet (2005)
Bcs Classification Database Structure
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