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Валидированные методы

Валидированные методы


Разработка и валидация биоаналитических методик проводится в соответствии с требованиями ФГБУ «НЦЭСМП» Минздрава России, Евразийского экономического союза, FDA и EMA. Под вашу задачу может быть разработана высокочувствительная аналитическая методика, отвечающая требованиям протокола клинического исследования.

Compound

(Metabolite, Biomarker)

Matrix

Method

LLOQ

Status

Abacavir

Plasma

LC-MS/MS

50 ng/mL

Active

Abacavir/

Lamivudine

Plasma

LC-MS/MS

50 ng/mL

50 ng/mL

Active

Abiraterone

Plasma

LC-MS/MS

0.2 ng/mL

Active

Acetaminophen /

Chlorpheniramine

Plasma

LC-MS/MS

10 ng/mL

0.1 ng/mL

Active

Acetylsalicylic acid /

Salicylic acid

Plasma

LC-MS/MS

4 ng/mL

15 ng/mL

Active

Ademethionine

Plasma

LC-MS/MS

10 ng/mL

Active

Ambroxol

Plasma

LC-MS/MS

1 ng/mL

Active

Ambroxol /

Cetirizine

Plasma

LC-MS/MS

1 ng/mL

4 ng/mL

Active

p-Aminosalicylic acid

Plasma

LC-MS/MS

50 ng/mL

Active

Amlodipine

Plasma

LC-MS/MS

0.2 ng/mL

Active

Amlodipine /

Metoprolol

Plasma

LC-MS/MS

0.2 ng/mL

0.1 ng/mL

Active

Amlodipine /

Telmisartan

Plasma

LC-MS/MS

0.2 ng/mL

2.5 ng/mL

Active

Amoxicilline /

Clavulanic acid

Plasma

LC-MS/MS

100 ng/mL

50 ng/mL

Active

Anandamide

Plasma

LC-MS/MS

0.1 ng/mL

Active

2-Arachidonoyl glycerol

Plasma

LC-MS/MS

0.5 ng/mL

Active

Arginine

Plasma

LC-MS/MS

4 µg/mL

Active

Atazanavir

Plasma

LC-MS/MS

5 ng/mL

Active

Atorvastatin

Plasma

LC-MS/MS

0.2 ng/mL

Active

Bosentan

Plasma

LC-MS/MS

5 ng/mL

Active

Bicalutamide

Plasma

LC-MS/MS

10 ng/mL

Active

Capecitabine /

5-Fluorouracil

Plasma

LC-MS/MS

20 ng/mL

20  ng/mL

Active

Celecoxib

Plasma

LC-MS/MS

10 ng/mL

Active

Cetirizine (Levocetirizine)

Plasma

LC-MS/MS

1 ng/mL

Active

Cinacalcet

Plasma

LC-MS/MS

0.1 ng/mL

Active

Cisplatine

Plasma

LC-MS/MS

1 ng/mL

Active

Citalopram

Plasma

LC-MS/MS

0.3 ng/mL

Active

Coenzyme Q10  /

reduced Coenzyme Q10 (ubiquinol)/

Coenzyme Q9

Plasma

Tissue

LC-MS/MS

1 µg/mL

Active

Corticosterone

Urine

HPLC/UV

5 ng/mL

Active

Cortineff

Urine

LC-MS/MS

1 ng/mL

Inactive

Cortisol (6ß-Hydroxycortisol)

Urine

HPLC/UV

5 ng/mL

Active

Cortisone

Urine

HPLC/UV

5 ng/mL

Active

Creamide

Plasma

LC-MS/MS

0.1 µg/mL

Active

Cycloserine

Plasma

LC-MS/MS

0.3 µg/mL

Active

Dapoxetine

Plasma

LC-MS/MS

1 ng/mL

Active

Darunavir

Plasma

LC-MS/MS

50 ng/mL

Active

Dasatinib

Plasma

LC-MS/MS

1 ng/mL

Active

Dexamethasone

Urine

HPLC/UV

1 ng/mL

Active

Docetacel

Plasma

LC-MS/MS

2 ng/mL

Active

Dopamine

Plasma

Urine

HPLC/ED

0.35 ng/mL

Active

Doxorubicin

Plasma

Tissue

LC-MS/MS

0.5 ng/mL

Active

Dutasteride /

Tamsulosin

Plasma

LC-MS/MS

0.1/

0.2 ng/mL

Active

Efavirenz

Plasma

LC-MS/MS

100 ng/mL

Active

Emtricitabine

Plasma

LC-MS/MS

20 ng/mL

Active

Emtricitabine /

Tenofovir

Plasma

LC-MS/MS

10 ng/mL

4 ng/mL

Active

Entecavir

Plasma

LC-MS/MS

0.1 ng/mL

 

Active

Epinephrine

Plasma

Urine

HPLC/ED

0.2 ng/mL

Active

Eplerenone

Plasma

LC-MS/MS

25  ng/mL

Active

Eremomycin

Plasma

LC-MS/MS

50 ng/mL

Active

Etoricoxib

Plasma

LC-MS/MS

-

Development

Fexofenadine

Plasma

LC-MS/MS

1 ng/mL

Active

Finasteride

Plasma

LC-MS/MS

-

Development

Fingolimod ( FTY720 )/

Fingolimod phosphate ( FTY720-P)

Blood

LC-MS/MS

50 pg/mL

70 pg/mL

Active

Fosfomycin

Plasma

LC-MS/MS

-

 

Gliclazide

Plasma

LC-MS/MS

20 ng/mL

Active

Homovanillic acid

Urine

HPLC/ED

10 ng/mL

Active

Ibuprofen

Plasma

LC-MS/MS

200 ng/mL

Active

Imatinib

Plasma

LC-MS/MS

5 ng/mL

Active

Ketorolac

Plasma

LC-MS/MS

10 ng/mL

Active

Kynurenine

Plasma

HPLC/UV

10 ng/mL

Inactive

Kynurenic acid

Plasma

HPLC/UV

20 ng/mL

Inactive

Lenalidomide

Plasma

LC-MS/MS

1 ng/mL

Active

Levetiracetam

Plasma

LC-MS/MS

200 ng/mL

Active

Levofloxacin

Plasma

LC-MS/MS

250 ng/mL

Active

Lidocaine

Plasma

LC-MS/MS

1 ng/mL

Active

Linezolid

Plasma

LC-MS/MS

100 ng/mL

Active

Lipoic acid

Plasma

LC-MS/MS

5 ng/mL

Active

Lisinopril

Plasma

LC-MS/MS

5 ng/mL

Active

Losartan

Plasma

LC-MS/MS

5 ng/mL

Active

Irbesartan

Plasma

LC-MS/MS

5 ng/mL

Active

Marcaine

Plasma

Tissue

LC-MS/MS HPLC/UV

1 ng/mL

Active

Mebeverin Acid/

o-desmethyl mebeverine acid

Plasma

LC-MS/MS

1 ng/mL

5 ng/mL

Active

Meloxicam

Plasma

 

LC-MS/MS

10  ng/mL

Active

Melphalan

Plasma

Tissue

LC-MS/MS

0.3 ng/mL

Active

Memantine

Plasma

LC-MS/MS

0.3 ng/mL

Active

Metanephrine

Urine

HPLC/ED

10 ng/mL

Active

Metoprolol

Plasma

LC-MS/MS

0.1 ng/mL

Active

Mexidol (Emoxypine)

Plasma

LC-MS/MS

0.5 ng/mL

Active

Mildronate

Plasma

LC-MS/MS

50 ng/mL

Active

4-Methylaminoantipyrine (Metamizole metabolite)

Plasma

LC-MS/MS

100  ng/mL

Active

Mitomicyn C

Plasma

Tissue

LC-MS/MS

0.6 ng/mL

Active

Mitoxantrone

Plasma

Tissue

LC-MS/MS

5 ng/mL

Inactive

Montelukast/

Cetirizine

Plasma

LC-MS/MS

10 ng/mL

1 ng/mL

Active

Moxifloxacin

Plasma

LC-MS

2 ng/mL

Active

Naftidrofuryl

Plasma

LC-MS/MS

10  ng/mL

Active

Naloxone

Plasma

LC-MS/MS

80 pg/mL

Active

Naltrexone

Plasma

LC-MS/MS

150 pg/mL

Active

Nevirapine

Plasma

LC-MS

80 ng/mL

Active

Nifedipine/

Lidocaine

Plasma

LC-MS/MS

0.5 ng/mL

1 ng/mL

Active

Nilotinib

Plasma

LC-MS/MS

2 ng/mL

Active

Nimesulide

Plasma

LC-MS/MS

20 ng/mL

Active

Norepinephrine

Plasma

Urine

HPLC/ED

0.2 ng/mL

Active

Normetanephrine

Urine

HPLC/ED

5 ng/mL

Active

Oxybutynin

Plasma

Tissue

LC-MS/MS

0.5 ng/mL

Active

Oseltamivir carboxylate

Plasma

LC-MS/MS

2 ng/mL

Active

PAS (4-Aminosalicylic acid)

Plasma

LC-MS/MS

50  ng/mL

Active

Penciclovir

Plasma

LC-MS/MS

50 ng/mL

Active

Perindopril /

Perindoprilat

Plasma

LC-MS/MS

0.4 ng/mL

Active

Perindoprilat /

Indapamide

Plasma

LC-MS/MS

0.4 ng/mL

0.3 ng/mL

Active

Phenibut

Plasma

LC-MS/MS

10 ng/mL

Active

Phenylephrine

Plasma

LC-MS/MS

-

Development

Pregabalin

Plasma

LC-MS/MS

50 ng/mL

Active

Rabeprazole

Plasma

LC-MS

2 ng/mL

Active

Ranolazine

Plasma

LC-MS/MS

5 ng/mL

Active

Ramipril /

Ramiprilat

Plasma

LC-MS/MS

0.2 ng/mL

0.5 ng/mL

Active

Ritonavir

Plasma

LC-MS/MS

5 ng/mL

Active

Rivaroxaban

Plasma

LC-MS/MS

0.5 ng/mL

Active

Rhein (Diacerein)

Plasma

HPLC/UV

100 ng/mL

Active

Ropinipole

Plasma

LC-MS/MS

10 pg/mL

Active

Rosuvastatin

Plasma

LC-MS/MS

0.2 ng/mL

Active

Salbutamol

Plasma

LC-MS/MS

0.2 ng/mL

Active

Serotonin

Plasma

HPLC/UV

10 ng/mL

Active

Sildenafil

Plasma

LC-MS

5 ng/mL

Active

Sildenafil

Plasma

LC-MS/MS

1 ng/mL

Active

Simvastatine / Simvastatin acid

Plasma

LC-MS/MS

-

Development

Spironolactone /

Canrenone

Plasma

LC-MS/MS

2 ng/mL

2 ng/mL

Active

Stavudine

Plasma

HPLC/UV

30 ng/mL

Active

Succinic acid

Plasma

LC-MS/MS

0.1 µg/mL

Active

Tacrolimus

Blood

LC-MS/MS

0.5 ng/mL

0.1 ng/mL

Active

Active

Telmisartan

Plasma

LC-MS/MS

3 ng/mL

Active

Telmisartan/

Hydrochlorothiazide

Plasma

LC-MS/MS

3 ng/mL

1 ng/mL

Active

Tenofovir

Plasma

LC-MS/MS

4 ng/mL

Active

Terizidone

Plasma

LC-MS/MS

0.3 µg/mL

Active

Thyroxine (T4)

Serum

LC-MS/MS

30 ng/mL

Active

Troventol

Plasma

LC-MS/MS

35 pg/mL

Active

Troxerutin

Plasma

LC-MS/MS

-

Development

Tryptophan

Plasma

HPLC/UV

10 ng/mL

Active

Quetiapine

Plasma

LC-MS/MS

1  ng/mL

Active

Valsartan

Plasma

LC-MS/MS

10 ng/mL

Active

Vanillyl mandelic acid

Urine

HPLC/UV

10 ng/mL

Active

Vinblastine

Plasma

Tissue

LC-MS/MS HPLC/UV

1 ng/mL

Active

Voriconazole

Plasma

LC-MS

20 ng/mL

Active

Zidovudine

Plasma

LC-MS/MS

40 ng/mL

Active

Zidovudine /

Lamivudine

Plasma

LC-MS/MS

30 ng/mL

25 ng/mL

Active

Полный перечень валидированных методик

Контакты

Наш адрес:


195220, Санкт-Петербург,
ул. Гжатская, д. 27, оф. 240, а/я 27

Тел.:

8 (812) 294-82-04

Факс:

8 (812) 294-82-04

E-mail:

info@csuas.ru
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